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Not graded by the source2010-04-16FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03546da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON (B)(4) 2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2010. ON (B)(6) 2010, APPROXIMATELY 1 WEEK BEFORE THE HYSTERECTOMY PROCEDURE, THE PATIENT UNDERWENT A LOOP ELECTROSURGICAL EXCISION PROCEDURE (LEEP) AND ENDOCERVICAL CURETTAGE TO EVALUATE A HIGH-GRADE DYSPLASIA WITH FINDINGS OF SMALL FOCUS OF MICROINVASIVE SQUAMOUS CELL CARCINOMA OF THE CERVIX. ON (B)(6) 2010, THE PATIENT UNDERWENT THE DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO OOPHORECTOMY. ACCORDING TO THE OPERATIVE REPORT, THE NEOVASCULARIZATION AND HYPERTROPHY OF SMALL VESSELS WERE NOTED WITH INCREASED OOZING OF BLOOD, WHICH WAS CONTROLLED WITH CAUTERY AND CLOSURE OF THE VAGINAL CUFF. THE VAGINAL CUFF WAS CLOSED BY TAKING GENEROUS BITES BACK FROM THE DIVIDED EDGES OF THE VAGINA AS THE PATIENT WAS AT INCREASED RISK OF POOR WOUND HEALING AND SEROMA FORMATION, AS WELL AS POSTOPERATIVE HEMATOMA FORMATION. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION; NO COMPLICATIONS WERE NOTED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THE OPERATIVE REPORTS DID NO
cause not established2955842-2013-03546Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-04-12FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2010-00191da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGEON NOTICED A BURN MARK ON THE PATIENT'S ABDOMEN, LOCATED AT ONE OF THE PORT INCISIONS WHERE A CANNULA ACCESSORY WAS USED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH NO ADDITIONAL PATIENT HARM.
cause not established2955842-2010-00191Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-04-09FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04924da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL HYSTERECTOMY FOR REFRACTORY MENORRHAGIA ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORTS. IN ADDITION, A PATHOLOGY REPORT WAS PROVIDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE PROCEDURE WAS UNEVENTFUL - OVARIES WERE LEFT IN PLACE PER PATIENT'S WISHES. THE UTERUS WEIGHED 134 GRAMS. SHE WAS MOVED TO THE POST-ANESTHESIA CARE UNIT IN GOOD CONDITION. ESTIMATED BLOOD LOSS WAS 450ML. SHE WAS DISCHARGED HOME ON (B)(6) 2010 FOR A TOTAL STAY OF ONE DAY. ON (B)(6) 2010 THE PATIENT PRESENTED WITH NAUSEA, VOMITING AND ABDOMINAL PAIN. SHE REPORTED A BROWNISH RED VAGINAL DISCHARGE. A DIAGNOSIS OF POSTOP ILEUS WAS MADE. A CT SCAN WAS CONDUCTED ON (B)(6) 2010 AND NOTED ATELECTASIS IN BOTH LOWER LUNG FIELDS. A PULMONARY THROMBOEMBOLISM WAS NOT NOTED, BUT POSSIBLE EARLY INFILTRATES WERE NOTICED IN THE RIGHT BASE COULD BE EARLY PNEUMONIA. KIDNEYS WERE NOTED AS NORMAL. A LATER PYELOGRAM NOTED LEFT HYDRONEPHROSIS AND A DILATED
cause not established2955842-2013-04924Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-03-30FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04337da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI AFIB PROCEDURE ON (B)(6) 2010. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'DEATH'.
cause not established2955842-2013-04337Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-03-26FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2010-00122da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI SI THYROIDECTOMY PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS DUE TO RADIAL NERVE DAMAGE.
cause not established2955842-2010-00122Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-03-25FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04949da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY FOR A PELVIC MASS, AN ENLARGED UTERUS, ATYPICAL CELLS ON ENDOMETRIAL BIOPSY, AND UNSATISFACTORY ENDOMETRIAL BIOPSY PLUS UTERINE FIBROIDS ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: DISCHARGE SUMMARY FROM (B)(6) 2010, SURGICAL PATHOLOGY REPORT (B)(6) 2010, HISTORY AND PHYSICAL (H&P) (B)(6) 2010, OR REPORT (B)(6) 2010 AND THE ATTORNEYS CLAIM FORM. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. AFTER PLACEMENT OF THE UTERINE MANIPULATOR AND DEVELOPMENT OF A PNEUMOPERITONEUM THROUGH AN OPEN INCISION IN THE LUQ, ALL PORTS WERE PLACED UNDER DIRECT VISUALIZATION. THEN, THE ROUND LIGAMENTS WERE BILATERALLY SEALED AND DIVIDED, THE BLADDER FLAP DEVELOPED USING SHARP DISSECTION, BOTH URETERS IDENTIFIED AND THE INFUNDIBULOPELVIC LIGAMENTS SEALED AND DIVIDED. COLPOTOMY WAS PERFORMED CIRCUMFERENTIALLY ONTO THE UTERINE MANIPULATOR CUP AND THE
cause not established2955842-2013-04949Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-03-19FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04774da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY MENORRHAGIA AND ENDOMETRIOSIS PROCEDURE ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDE HOSPITAL NOTES, OFFICE NOTES, RADIOLOGY REPORTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2010 THE PATIENT WAS ADMITTED FOR ROBOTIC TOTAL HYSTERECTOMY. THE PATIENT WAS DISCHARGED HOME THE NEXT DAY IN STABLE CONDITION. ON (B)(6) 2010, THE PATIENT WAS RE-ADMITTED FOR VAGINAL CUFF DEHISCENCE AND UNDERWENT SURGICAL REPAIR VIA A VAGINAL APPROACH. THIS PATIENT HAD A VERY SMALL CUFF PELVIC HEMATOMA AND RESULTANT CUFF SEPARATION WITHOUT EVISCERATION, INFECTION OR COMPLICATION.
cause not established2955842-2013-04774Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-03-18FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2010-00156da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI MYOMECTOMY PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS IN HER HANDS AND FINGERS AND SHARP PAIN AND TINGLING IN HER LEGS. PER THE SURGEON THAT PERFORMED THE OPERATION, THE MYOMECTOMY PROCEDURE TOOK LONGER THAN ANTICIPATED, APPROXIMATELY 5 HOURS, WITH THE PATIENT IN THE TRENDELENBURG POSITION. PER THE OPERATIVE REPORT THE PATIENT TOLERATED THE ENTIRE PROCEDURE WELL WITH GOOD HEMOSTASIS AND MINIMAL BLOOD LOSS.
cause not established2955842-2010-00156Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-03-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2010-00140da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT APPROXIMATELY 45 MINUTES INTO A DA VINCI PROSTATECTOMY PROCEDURE, WHILE THE SURGEON WAS PERFORMING A DISSECTION, THE MONOPOLAR FOOT PETAL WAS PRESSED, HOWEVER, THE BIPOLAR ENERGY BECAME ACTIVATED. THE BIPOLAR INSTRUMENT WAS HOLDING TISSUE AND CREATED A SUPERFICIAL LACERATION TYPE BURN TO THE PATIENT'S BOWEL. A GENERAL SURGEON REVIEWED THE INJURY AND DETERMINED THAT THE BURN WAS NOT THROUGH AND THROUGH AND DID NOT REQUIRE REPAIR, HOWEVER, THE SURGEON PLACED ONE SUTURE IN THE PATIENT'S BOWEL AS A PRECAUTION. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH THE SAME EQUIPMENT AND NO FURTHER INSTANCES OF THE EVENT WAS REPORTED.
cause not established2955842-2010-00140Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-03-09FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04759da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT HAD UNDERWENT A DA VINCI HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, PLICATION OF THE UTEROSACRAL LIGAMENT AND LYSIS OF ADHESIONS FOR THE INDICATION OF FIBROID UTERUS AND MENOMETRORRHAGIA PROCEDURE ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY AND FOLLOW UP SURGERY AND OFFICE NOTES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THE PATIENT'S UTERUS WAS NOTED TO BE LARGE AND DEFORMED WITH SEVERAL FIBROIDS, AND AN ADHESION OF THE LEFT OVARY TO THE PELVIC SIDEWALL WITH A CLEAR FLUID CYST. THE STANDARD PROCEDURE WAS PERFORMED WITH ISOLATION, CAUTERIZATION AND CUTTING OF THE LATERAL LIGAMENTS AND UTERINE ARTERIES BILATERALLY. THE RIGHT SIDE WAS NOTED TO BE ADHERED TO THE RIGHT ABDOMINAL WALL MAKING ACCESS TO THE IP LIGAMENT DIFFICULT. THE VAGINAL INCISION WAS MADE AROUND A VCARE AND THE UTERUS DELIVERED VAGINALLY. THE VAGINAL CUFF WAS CLOSED WITH 0 VICRYL, THE UTEROSACRAL LIGAMENT PLICATED. NO COMPLICATIONS WERE NOTED DURING THE SURGERY. ON (B)(6), THE PATIENT PRESENTED WITH A HIS
cause not established2955842-2013-04759Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-03-08FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03193da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, ON JULY 25, 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI SUPRACERVICAL HYSTERECTOMY PROCEDURE ON (B)(6) 2010. NO INTRA-OPERATIVE COMPLICATIONS WERE DOCUMENTED IN THE OPERATIVE REPORT. AFTER THE PATIENT'S UTERUS WAS RESECTED AND MORCELLATED, HER PELVIS WAS IRRIGATED. THE OPERATIVE REPORT STATED THAT EXCELLENT HEMOSTASIS WAS NOTED. UPON CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT'S SKIN INCISIONS WERE CLOSED. SHE WAS THEN EXTUBATED AND ESCORTED TO RECOVERY IN EXCELLENT CONDITION. BASED ON THE PATIENT'S MEDICAL RECORDS, THE PATIENT EXPERIENCED VAGINITIS AND VAGINAL INFECTIONS ON MULTIPLE OCCASIONS BETWEEN (B)(6) 2010 AND (B)(6), 2012. ON (B)(6) 2012, THE PATIENT HAD AN OFFICE VISIT AND WAS EVALUATED FOR HYDRONEPHROSIS. THE OFFICE VISIT REPORT STATED THAT THE PATIENT HAD AN MRI THAT REVEALED LEFT SIDED HYDRONEPHROSIS. IT IS UNKNOWN WHAT DATE THE MRI WAS PERFORMED. THE OPERATIVE REPORT ALSO STATED THAT THE PATIENT HAS BEEN TOLD THAT SHE HAS HAD HYDRONEPHROSIS IN THE PAST. ON (B)(6) 2012, A CT SCAN WAS PERFORMED ON THE PATIENT'S ABDOMEN AND PELVIS. THE CT SCAN
cause not established2955842-2013-03193Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-03-02FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2010-00238da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON MAY 4, 2010, A WALL STREET JOURNAL (WSJ) ARTICLE TITLED "SURGICAL ROBOT EXAMINED IN INJURIES" WAS PUBLISHED. THE ARTICLE INCLUDED DETAILS CONCERNING PT INJURIES AND A PT DEATH AT (B) (6) HOSPITAL. NONE OF THE ALLEGATIONS OF PT INJURIES IN THE WSJ ARTICLE WERE REPORTED TO ISI, HOWEVER, ON (B) (6) 2010, UPON FOLLOW UP WITH THE HOSPITAL, (B) (6), THE VP OF COMMUNITY RELATIONS, CONFIRMED ONE PT INJURY. REPORTEDLY, AFTER A DA VINCI S HYSTERECTOMY PROCEDURE, THE PT DID NOT HAVE URINE OUTPUT. ON (B) (6) 2009, A CYSTOSCOPY WITH URETEROSCOPY AND EXPLORATORY LAPAROSCOPY PROCEDURE WAS PERFORMED WHICH REVEALED THAT THE PT HAD BILATERAL URETERAL TRANSECTION. BILATERAL URETERAL REIMPLANTATIONS AND A BILATERAL URETERAL STENT PLACEMENT WAS REQUIRED TO REPAIR THE AFFECTED AREA. IN ADDITION, (B) (6) STATED THAT (B) (6) HAS NO RECORD OF THE OTHER PT INJURIES/PT DEATH RELATED TO THE DA VINCI S SURGICAL SYSTEM AS INDICATED IN THE WSJ ARTICLE. DAMAGE TO THE PT'S URETER PROLONGED THE PT'S HOSPITALIZATION AND THE PT HAS RETURNED TO THE HOSPITAL DUE TO POST OPERATIVE COMPLICATIONS. THE HOSPITAL WAS UNABLE TO PROVIDE ADDITIONAL INFO CONCERNING THE PT'S STATUS.
cause not established2955842-2010-00238Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-02-26FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03158da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(4) 2013 INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION CONCERNING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2010. THE INFORMATION RECEIVED STATES THAT THE PATIENT SUSTAINED A THERMAL MONOPOLAR INJURY TO HER URETER DURING THE SURGICAL PROCEDURE WHICH CAUSED DOCUMENTED EXTRAVASATION OF URINE INTO THE PERITONEAL CAVITY AND THAT THIS WAS DIRECTLY CAUSATIVE TO THE FLUID COLLECTION AND INCREASED PELVIC PAIN THAT WAS THEN MISDIAGNOSED AS AN OVARIAN CYST. THE INFORMATION STATES THAT THE PATIENT UNDERWENT SURGICAL CASTRATION AS A DIRECT RESULT OF A COMPLICATION FROM HER DA VINCI HYSTERECTOMY. THE DOCUMENTATION STATES THAT AT THE TIME OF THE SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE A SMALL UTERUS, NORMAL OVARIES BILATERALLY, AND NO EVIDENCE OF EXTRA-CERVICAL DISEASE. DURING POST OPERATIVE FOLLOW UP THE PATIENT EXPERIENCED SHOULDER PAIN AND RECEIVED PHYSICAL THERAPY FOR A DIAGNOSIS OF COMPRESSION FROM SURGICAL POSITIONING. THE PATIENT RECEIVED NON STEROID ANTI-INFLAMMATORY TREATMENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010. ON (B)(6) 2010, THE DOCUMENTATION STATES THAT THE PATIENT RETURNED T
cause not established2955842-2013-03158Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-02-23FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04976da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY WITH BILATERAL SALPINGO OOPHORECTOMY, ADHESIOLYSIS, AND REPAIR OF VAGINAL WALL LACERATION PROCEDURE ON (B)(4) 2010 FOR AN ENLARGED FIBROID UTERUS, ANEMIA, PERSISTENT OVARIAN CYST, AND CHRONIC PELVIC PAIN. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES AN UNDATED OPERATIVE REPORT OF A FISTULA REPAIR, A PATHOLOGY REPORT FROM (B)(6) 2010, AND OFFICE NOTES FROM THE PRIMARY SURGEON DOCUMENTING THE PATIENT'S RECOVERY ON (B)(6) 2010. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. ACCORDING TO THE DA VINCI SURGICAL PROCEDURE OPERATIVE REPORT, THE PATIENT WAS NOTED TO HAVE A UTERUS THAT WAS ENLARGED, IRREGULAR, FIRM CONSISTENCY, AND HAD FIBROIDS. BOWEL ADHESIONS TO ANTERIOR ABDOMINAL WALL ON RIGHT WERE NOT IN DIRECT FIELD OF OPERATION; THEY WERE MORE LATERAL. ADHESIONS ON LEFT SIDE WERE LYSED TO GET BOWEL AWAY FROM INFUNDIBULOPELVIC LIGAMENTS. ON CONTRALATERAL SIDE, THE SURGEON LOOKED TO SEE IF MORE ROOM TO MANEUVER THE BULKY UTERUS AND NOTED IT WAS D
cause not established2955842-2013-04976Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-02-22FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03679da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI RADICAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY, COLLECTION OF PERITONEAL CYTOLOGY AND PELVIC LYMPHADENECTOMY ON (B)(6) 2010. THE PATIENT HAD A PRE-OPERATIVE DIAGNOSIS OF GRADE 2 ENDOMETRIAL CARCINOMA. ACCORDING TO THE PATIENT'S OPERATIVE (OP REPORT) THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED. REPORTEDLY, AT THE END OF THE SURGICAL PROCEDURE, EXCELLENT HEMOSTASIS WAS NOTED AFTER CLOSURE OF THE PATIENT'S VAGINAL CUFF WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO COMPLICATIONS EXPERIENCED BY THE PATIENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010. REPORTEDLY DURING A POST-OPERATIVE EXAMINATION ON (B)(6) 2010, IT WAS DISCOVERED THAT THE PATIENT HAD A SLIGHT VAGINAL CUFF DEHISCENCE AT THE APEX AND ON THE SAME DAY, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPAIR THE AFFECTED AREA.
cause not established2955842-2013-03679Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-02-22FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03914da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6), 2010. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED URINARY INCONTINENCE AND ERECTILE DYSFUNCTION.
cause not established2955842-2013-03914Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-02-15FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04923da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI'S PARTIAL NEPHRECTOMY PROCEDURE ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE PATIENT'S PRIMARY OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED THE HOSPITAL CONSULTATION AND OPERATIVE NOTES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE PATIENT EXPERIENCED PERSISTENT PAIN POST OPERATIVELY AND WAS FOUND TO HAVE A POSSIBLE SMALL BOWEL PERFORATION. ON (B)(6) 2010, AN EXPLORATORY LAPAROTOMY WAS PERFORMED WITH LYSIS OF ADHESIONS AND A SMALL BOWEL RESECTION. HE ALSO DEVELOPED A DEEP VEIN THROMBOSIS WITH PULMONARY EMBOLI AND DEVELOPED SOME EXTRAVASATION FROM THE OPERATIVE AREA OF HIS LEFT KIDNEY. HE ALSO DEVELOPED SOME PROBLEMS WITH ATRIAL FIBRILLATION. ACCORDING TO THE PATIENT'S DISCHARGE SUMMARY REPORT, DURING THE PATIENT'S PRIMARY SURGICAL PROCEDURE, THE OPERATION INVOLVED A FAIR AMOUNT OF LYSIS OF ADHESION IN ORDER TO GET THE TROCARS IN.
cause not established2955842-2013-04923Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-02-13FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04920da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY WITH PELVIC AND PARA-AORTIC LYMPH NODE SAMPLING, URETEROLYSIS, AND CYSTOSCOPY WITH STENT PLACEMENT ON (B)(6) 2010. THE PATIENT WAS DIAGNOSED WITH STAGE IB-1 CERVICAL ADENOSQUAMOUS CARCINOMA. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HISTORY AND PHYSICAL EXAM, PATHOLOGY REPORTS, DISCHARGE SUMMARY, SUBSEQUENT OPERATIVE NOTES FROM UROLOGY, UROLOGY CONSULTATIONS AND HOSPITAL DISCHARGE SUMMARIES. THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ACCORDING TO THE INFORMATION PROVIDED, ON (B)(6) 2010, THE PATIENT PRESENTED WITH LOWER ABDOMINAL PAIN AND WAS ADMITTED FOR EVALUATION AND WAS FOUND TO HAVE A LEFT URETERAL INJURY. A PERITONEAL FLUID COLLECTION WAS DRAINED ON (B)(6) 2010, A LEFT PERCUTANEOUS NEPHROSTOMY TUBE WAS PLACED, CT AND X-RAYS WERE OBTAINED AND A RETROGRADE UROGRAM WAS PERFORMED. THE PATIENT THEN WENT TO SURGERY WHERE A CYSTOSCOPY, A NEPHROSTOG
cause not established2955842-2013-04920Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-02-05FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2010-00084da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE, THE PHYSICIAN AT THE SURGEON SIDE CONSOLE INTERMITTENTLY FELT A SHOCK IN HIS FINGERTIPS FROM THE RIGHT MASTER TOOL MANIPULATOR (MTMR). THE SURGEON SWITCHED TO THE SITE'S SECOND SURGEON SIDE CONSOLE TO COMPLETE THE PLANNED PROCEDURE AND NO FURTHER OCCURRENCES OF SHOCK WERE REPORTED. NO HARM TO THE PHYSICIAN OR PATIENT WAS REPORTED.
cause not established2955842-2010-00084Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-02-03FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-02026da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY AND CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2010. THE LEGAL FILING CLAIMS THAT AT SOME POINT DURING THE DA VINCI SI SURGICAL PROCEDURE THE PATIENT'S RIGHT OVARY WAS REMOVED WITHOUT HER CONSENT OR KNOWLEDGE. THE PATIENT REPORTEDLY DISCOVERED THAT HER RIGHT OVARY WAS MISSING AFTER UNDERGOING A SURGICAL PROCEDURE ON (B)(6) 2013 TO REMOVE HER LEFT OVARY. AFTER COMPLETION OF THE SURGICAL PROCEDURE PERFORMED ON (B)(6) 2013, THE SURGEON INFORMED THE PATIENT THAT THERE WAS SCAR TISSUE WHERE HER RIGHT OVARY SHOULD HAVE BEEN, AND THAT THE RIGHT OVARY WAS GONE. THE LEGAL FILING INDICATES THAT THE ONLY SURGICAL PROCEDURE THE PATIENT HAD PRIOR TO (B)(6) 2013, WAS THE DA VINCI PROCEDURE PERFORMED ON (B)(6) 2010.
cause not established2955842-2013-02026Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-01-27FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2010-00060da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT APPROXIMATELY 2.5 HOURS INTO A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGEON BEGAN TO INITIATE A TOOL CHANGE TO SWITCH INSTRUMENTS. AT THIS TIME THE NURSE ASSISTANT WHO WAS RETRACTING THE PATIENT'S UTERUS, DROPPED THE UTERUS CAUSING THE SURGEON TO LOSE SITE OF THE TENNACULUM FORCEPS INSTRUMENT IN USE. THE PATIENT SIDE MANIPULATOR (PSM) ARM THAT THE TENNACULUM FORCEPS INSTRUMENT WAS INSTALLED ON BECAME UNRESPONSIVE. THE ISI REPRESENTATIVE ONSITE HAD THE SURIGCAL STAFF EMERGENCY STOP THE SYSTEM AND PERFORM A FAULT OVER-RIDE, HOWEVER, THE PSM CONTINUED TO BE UNRESPONSIVE. THE PATIENT'S UTERUS WAS MOVED, AND THE SURGICAL STAFF FOUND THAT THE TENNACULUM FORCEPS INSTRUMENT WAS CLOSED ON THE PATIENT'S RECTUM AND THEY WERE UNABLE TO RELEASE THE INSTRUMENT. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER, THE INSTRUMENT WAS RELEASED AND REMOVED FROM THE PSM. A GENERAL SURGEON WAS REQUESTED TO ATTEND THE PROCEDURE AND ALTHOUGH THERE WERE NO VISIBLE HOLES, TEARS, OR PINCHES IN THE PATIENT'S RECTUM, HE PLACED A FEW SUTURES AS A PRECAUTION. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH OUT ANY FURTHER PATIENT HARM, INJURY OR ADVERSE OUTCOME REPORTED.
cause not established2955842-2010-00060Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-01-27FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03516da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2010. THE MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD PREOPERATIVE DIAGNOSIS OF MENORRHAGIA AND FIBROIDS. ACCORDING TO THE OPERATIVE REPORT OF THE DA VINCI S HYSTERECTOMY, THE SURGEON STATED THAT ENDOMETRIOSIS AND FIBROIDS WERE FOUND AROUND THE LEFT SIDE OF THE BROAD LIGAMENT. THE SURGEON ALSO STATED THAT THE URETER WAS DIFFICULT TO SEE AND IN TRYING TO DISSECT OUT THE FIBROIDS FROM THE PREPERITONEAL SPACE, THE URETER WAS INADVERTENTLY TRANSECTED. UROLOGY WAS CALLED FOR ASSISTANCE. A FIBROID WAS FOUND EXTENDING AROUND THE URETER ON THE LEFT AND WAS REMOVED. AT THAT POINT, THE SURGEON MADE THE DECISION TO COMPLETE THE PROCEDURE AS A SUPRACERVICAL HYSTERECTOMY. AFTER COMPLETION OF THE HYSTERECTOMY, A SURGEON FROM UROLOGY MADE THE DECISION TO OPEN THE PATIENT FOR OPEN REANASTOMOSIS OF THE URETER INTO THE BLADDER. THE SURGEON PERFORMED A LEFT URETERAL RE-IMPLANT WITH STENT PLACEMENT. THE PATIENT'S FOLEY
cause not established2955842-2013-03516Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-01-14FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03681da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2010 AND ALLEGED TO HAVE INJURIES INCLUDING POSTOPERATIVE HEMORRHAGING. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
cause not established2955842-2013-03681Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-01-14FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00253da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON MAY 8, 2012, INTUITIVE SURGICAL RECEIVED A LEGAL COMPLAINT THAT ALLEGED THE FOLLOWING: ON (B)(6) 2010, A PATIENT UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE WITH A LEFT SALPINGO-OOPHORECTOMY AT (B)(6). THERE WERE NO RECORDS OF ANY COMPLICATIONS DURING THE SURGERY AND THE PATIENT WAS DISCHARGED ON (B)(6) 2010. ON (B)(6) 2010, THE PATIENT EXPERIENCED SEVERE PAIN IN HER LOWER ABDOMEN AND FEVER AND WAS SUBSEQUENTLY RE-ADMITTED TO (B)(6). THE PATIENT WAS IMMEDIATELY STARTED ON TRIPLE INTRAVENOUS ANTIBIOTIC THERAPY INCLUDING ROCEPHIN, GENTAMICIN, AND FAGYL. A DIAGNOSIS OF PELVIC ABSCESS ALONG THE VAGINAL CUFF WAS MADE. SECONDARY TO THIS, THE PATIENT HAD RADIOLOGY TESTS DONE, INCLUDING A CT SCAN OF THE ABDOMEN AND PELVIS WITH ORAL AND INTRAVENOUS CONTRAST, THAT CONFIRMED A LARGE MASS IN THE LEFT LOWER QUADRANT AND PELVIS HAVING INFLAMMATORY-TYPE FEATURES AND CONTAINING AIR MOST SUGGESTIVE OF AN ABSCESS. THE MASS WAS MEASURED TO BE 7.3 X 5.1 CENTIMETERS IN SIZE. THE READING RADIOLOGIST ALSO NOTED THAT THIS COULD ALSO BE A NECROTIC TYPE MASS WHICH COMMUNICATES WITH BOWEL. THE PATIENT WAS NOTED TO HAVE AN ELEVATED WHITE BLOOD CELL COUNT WITH A LEFT SHIFT CONSISTENT WITH SEPSIS. ON (B)(6
cause not established2955842-2012-00253Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2010-01-06FDA MAUDEZimmer BiometMW5178577ROSA Robotic Surgery
ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2020 I HAD A STEREOTACTIC EEG PERFORMED AT (B)(6). THE ROSA ONE BRAIN ROBOT WAS USED DURING THIS SURGERY TO PLACE 16 DEPTH ELECTRODES INTO MY BRAIN. THE LEADS WERE MISPLACED DURING THIS TEST GIVING MISINFORMATION TO THE DOCTORS. SUBSEQUENTLY WHEN MY NEUROPACE STIMULATOR WAS IMPLANTED THE LEADS WERE PLACED WRONG. ONE OF THE LEADS WAS IN MY HIPPOCAMPUS CAUSING PAIN FROM THE STIMULATION AND WAS TURNED OFF. THE OTHER LEAD WAS PLACED NEXT TO THE FORAMEN OVALE, CAUSING ME TO FEEL THE STIMULATION IN MY LEFT TEMPLE AND EYE AND CAUSING FACIAL PAIN. THE PAIN WAS VERY INTENSE, AND I HAVE LASTING EYE PAIN, ISSUES WITH MY LEFT EYE AND EXTREME MEMORY ISSUES. AFTER 4 YEARS OF ARGUING THIS INFORMATION WAS GIVEN TO ME AND SURGERY WAS PERFORMED IN 2024 TO REMOVE AND REIMPLANT THE DEVICE AND LEADS DUE TO THEM BEING PLACED WRONG. DURING THIS TIME, I HAD MORE INTENSE AND MORE FREQUENT SEIZURES AS WELL I HAVE FREQUENT MIGRAINE HEADACHES FROM ALL THE INCISIONS AND SCARE TISSUE AND EXTREME ANXIETY OVER WHETHER I HAVE ONCE AGAIN FELT THE STIMULATION OR NOT. PT CODES: 4467; 1994; 1958; 4406; 1880; 2060; 2328; 1924. DEVICE CODES: 1508, 1158, 3023. REF REPORT: MW5178578.
cause not establishedMW5178577Zimmer BiometRead the record ↗Not graded by the source2010-01-04FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04947da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S PROSTATECTOMY FOR PROSTATE CANCER ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: FOLLOW UP NOTES THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION OF A LOST NEEDLE. THE NEEDLE BECAME DISLODGED INTO THE PATIENT AND CONVERSION TO AN OPEN LAPAROTOMY WAS REQUIRED ADDING 2 HOURS TO THE CASE. TOTAL OPERATING TIME WAS 10 HOURS. THE SURGEON NOTED IN THE OPERATIVE REPORT THAT AT AROUND THE 1 O'CLOCK POSITION THE NEEDLE SNAPPED FROM THE SUTURE. I ATTEMPTED TO GRAB THE SUTURE TO KEEP TENSION IN ORDER TO PLACE A LAPRATY TO COMPLETE THE ANASTOMOSIS, HOWEVER, DURING THIS, THE NEEDLE HAD FALLEN AND WAS OUT OF MY SIGHT. WE LOOKED FOR THE NEEDLE DEEP IN THE PELVIS IN THE AREA WHERE IT HAD BECOME DETACHED FROM THE SUTURE, HOWEVER, WE WERE UNSUCCESSFUL IN SEARCHING FOR IT. KNOWING THAT THE LAPAROSCOPIC VISION WITH THE CAMERA WAS SUPERIOR THAN OPENING, WE DID TAKE OUR TIME SEARCHING FOR THE NEEDLE. INTRAO
cause not established2955842-2013-04947Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-12-31FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04281da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2009. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY:HAD A FISTULA, HAD TO WEAR A CATHETER AND COLOSTOMY FOR 10 MONTHS, HOLE BETWEEN URETHRA AND BOWELS.
cause not established2955842-2013-04281Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-12-30FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2010-00031da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED, THAT WHILE MOBILIZING THE LEFT INTERNAL MAMMARY ARTERY DURING A DA VINCI S CABG PROCEDURE, THE MICRO BIPOLAR FORCEPS (MBF) INSTRUMENT JUMPED FORWARD AND PUNCTURED THE PATIENT'S ARTERY. THE DAMAGED SECTION OF THE ARTERY WAS TRANSECTED AND THE HEALTHY PORTION OF THE ARTERY WAS USED TO COMPLETE THE BYPASS. IT WAS ALSO REPORTED THAT THROUGHOUT THE CASE, PNEUMO WAS ESTABLISHED AND LOST SEVERAL TIMES. THE ISI REPRESENTATIVE PRESENT DURING THE PROCEDURE INDICATED THAT PRIOR TO THE MBF INSTRUMENT JUMP, THE SURGEON NOTED THAT WHEN THE MASTER TOOL MANIPULATOR WAS MOVED, THE INSTRUMENT FELT STUCK AND THEN MOVED. IT IS BELIEVED THAT THE SURGEON CAUGHT THE MBF INSTRUMENT IN THE PATIENT'S RIB. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES OR PATIENT HARM.
cause not established2955842-2010-00031Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-12-18FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2009-00410da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED BY THE PT THAT SHE RECENTLY HAD A DA VINCI HYSTERECTOMY PROCEDURE AND WAS UNDER ANESTHESIA FOR 8 HOURS INSTEAD OF THE EXPECTED 4 HOURS DUE TO HER BEING SEVERELY OVERWEIGHT. SHE STATED THAT SHE WOKE UP AND WAS UNABLE TO MOVE EITHER OF HER ARMS, HOWEVER, AFTER TIME, SHE WAS ABLE TO GET FULL USE OF HER LEFT ARM. SHE STATED HER RIGHT ARM IS STILL IN A LOT OF PAIN.
cause not established2955842-2009-00410Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-12-17FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04968da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S TOTAL HYSTERECTOMY FOR MENORRHAGIA ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL OPERATIVE REPORTS AND HISTORY AND PHYSICAL DICTATION THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. 6 WEEKS AFTER SURGERY, THE PATIENT PRESENTED WITH COMPLAINED OF HAVING INTERCOURSE COMPLICATED BY SLIGHT VAGINAL BLEEDING AND THE LEAKAGE OF A WATERY FLUID. ON (B)(6) 2010, THE PATIENT WAS TAKEN BACK TO SURGERY FOR CYSTOSCOPY, AND INSPECTION OF URINARY TRACT. INDIGO CARMEN DYE TESTING FAILED TO SHOW ANY VESICO VAGINAL FISTULA AND THE URETERS APPEARED NORMAL ON RETROGRADE PYELOGRAM. A SINGLE SUTURE WAS USED TO CLOSE THE VAGINA. NO FURTHER INFORMATION WAS OBTAINED
cause not established2955842-2013-04968Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-12-14FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04997da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY FOR UTERINE FIBROIDS ON (B)(6) 2009 ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES OFFICE NOTES, OPERATIVE REPORTS, CONSULTATIONS, AND RADIOLOGY FINDINGS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2009 THE PATIENT WAS ADMITTED FOR LEAKAGE OF URINE. ON (B)(6) 2009, THE PATIENT UNDERWENT A LEFT URETEROSCOPY. THE UROLOGIST NOTED CAUTERY OF TISSUE IN HIS REPORT. COULD NOT PASS A GUIDE WIRE SO NO STENT WAS PLACED. THEREFORE, A NEPHROSTOMY TUBE WAS PLACED. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2009. ON (B)(6) 2010, THE PATIENT UNDERWENT A URETERAL RE-IMPLANTATION.
cause not established2955842-2013-04997Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-12-14FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04992da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY ON (B)(6) 2009 FOR PROSTATE CANCER. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED FOLLOW-UP HOSPITAL MEDICAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. AN INTRAOPERATIVE COMPLICATION WAS REPORTED, SPECIFICALLY AN UNINTENDED RECTOTOMY OCCURRED WHILE DISSECTING ADHERENT PROSTATE TISSUE. IT WAS REPAIRED PRIMARILY AT THE TIME. THE PATIENT WAS OBSERVED FOR 48 HOURS IN THE HOSPITAL WITHOUT APPARENT COMPLICATION AND WAS DISCHARGED HOME IN SATISFACTORY CONDITION TO BE FOLLOWED BY HIS PHYSICIAN.
cause not established2955842-2013-04992Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-12-03FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2010-00007da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE DAY FOLLOWING A SUCCESSFUL DA VINCI SI PROSTATECTOMY PROCEDURE, THE PT DEVELOPED COMPARTMENT SYNDROME IN THEIR RIGHT ARM. A SURGICAL PROCEDURE WAS PERFORMED TO RELIEVE PRESSURE TO THE PT'S AFFECTED AREA. NO ADD'L PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.
cause not established2955842-2010-00007Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-12-02FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04871da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI ROBOTIC HYSTERECTOMY FOR FIBROIDS, ABNORMAL BLEEDING AND PELVIC PAIN ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2009, ROBOTIC HYSTERECTOMY WITH LYSIS OF ADHESIONS. IT WAS NOTED THE USE OF HARMONIC SCALPEL AND ROBOTIC INSTRUMENTS DURING PROCEDURE. THE PATIENT WAS DISCHARGED ON (B)(6) 2009. ON (B)(6) 2010, THE PATIENT SUBSEQUENTLY WAS DIAGNOSED WITH A VESICOVAGINAL FISTULA AND UNDERWENT A VESICOVAGINAL FISTULA REPAIR WITH LEFT URETERAL REIMPLANTATION. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.
cause not established2955842-2013-04871Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-11-23FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04783da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S LAVH-LSO FOR HISTORY OF PELVIC PAIN AND IRREGULAR VAGINAL BLEEDING ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT AND SUBSEQUENT RENAL SCAN AND ABDOMINAL ULTRASOUND REPORTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. STANDARD DISSECTION WAS PERFORMED WITH PK DISSECTOR AND CAUTERY SCISSORS, UTERUS DELIVERED TRANSVAGINALLY, VAGINAL CUFF CLOSED, AND SKIN CLOSED. ON (B)(6) 2009, PATIENT PRESENTED WITH LEFT FLANK PAIN. AN INTRAVENOUS PYELOGRAM WAS PERFORMED WHICH SHOWED DILATION OF THE LEFT URETER WITH NARROWING NEAR THE BLADDER, NO EXTRAVASATION OF CONTRAST AND DELAYED EMPTYING OF THE BLADDER DATE OF DISCHARGE IS UNKNOWN. ON (B)(6) 2009, 3 WEEKS POSTOP, PATIENT RECEIVED RENAL SCAN WITH CONTRAST FOR LEFT FLANK AND PELVIC PAIN AND H/O HYDROURETER WHICH SHOWED NORMAL RENOGRAM WITH SOME PELVIC CONTRAST ACCUMULATION. ON (B)(6) 2009, A PELVIC TRANSABDOMINAL ULTRASOUND WAS PERFORMED FOR HISTORY OF CONSTIPATION AND PE
cause not established2955842-2013-04783Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-11-12FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04834da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY AND BILATERAL PELVIC LYMPH NODE DISSECTION PROCEDURE ON (B)(6) 2009 FOR CERVICAL CARCINOMA AND IDIOPATHIC THROMBOCYTOPENIA. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ADHESIONS WERE NOTED - THE OMENTUM WAS ADHERED TO THE RECTUS MUSCLES. ESTIMATED BLOOD LOSS WAS 650ML. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED ON (B)(6) 2009. ON (B)(6) 2009, THE PATIENT PRESENTED WITH LEAKING URINE. A CT SCAN SHOWED BILATERAL HYDROURETER AND URINE LEAKING IN THE PELVIC AREA, LEADING TO THE SUSPICION OF A URETERAL-VAGINAL FISTULA. PERCUTANEOUS NEPHROSTOMY WAS PERFORMED ON (B)(6) 2009. THE PATIENT WAS DISCHARGED ON (B)(6) 2009. SOMETIME BEFORE (B)(6) 2009, THE PATIENT WENT TO THE ER WHO DIAGNOSED VAGINAL CUFF DETACHMENT AND GREEN DRAINAGE. ON (B)(6) 2010, SHE WAS BROUGHT TO THE OPERATING ROOM FOR NEPHROSTOGRAMS AND A PYELOGRAM TO ASSESS THE URETERAL DEFECT FOR SURGICAL PLANNING AT
cause not established2955842-2013-04834Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-11-09FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03701da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2009. THE LEGAL COMPLAINT ALLEGED THAT THE DA VINCI SURGICAL SYSTEM MALFUNCTIONED AND THE PATIENT SUFFERED GRIEVOUS AND PERMANENT PERSONAL INJURIES, PAIN, SUFFERING AND LOSS OF ENJOYMENT OF LIFE, AGGRAVATION, EXACERBATION AND WORSENING OF PRE-EXISTING CONDITIONS, AND INCURRED PECUNIARY DAMAGES, MEDICAL, HOSPITAL, REHABILITATIVE AND OTHER EXPENSES, AND DIMINUTION OF CURRENT AND FUTURE EARNING CAPACITY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
cause not established2955842-2013-03701Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-10-31FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04280da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2009. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: DEVICE TORE A HOLE IN BLADDER, INCONTINENCE, USED CATHETER FOR 3 WEEKS.
cause not established2955842-2013-04280Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-10-28FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04045da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2009, AND ALLEGED TO HAVE SUSTAINED A PUNCTURED BOWEL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
cause not established2955842-2013-04045Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-10-16FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2009-00346da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON SEPTEMBER 18, 2009, A REUTERS ARTICLE TITLED "MEDICAL SOCIETIES PUSH STANDARDS FOR ROBOTIC SURGERY" WAS PUBLISHED. THE ARTICLE INCLUDES QUOTES FROM DR. KEVIN ZORN AND MENTIONS HIS RECOUNT OF A CASE WHERE A PATIENT DIED POST A DA VINCI PROSTATECTOMY PROCEDURE: "HE RECOUNTED ONE CASE OF A SURGEON WHO WAS USING THE SYSTEM FOR THE FOURTH TIME. AFTER EIGHT HOURS OF SURGERY, THE PROCTOR -- AN EXPERIENCED SURGEON WHO SUPERVISES THE OPERATION -- TOLD THE SURGEON THAT PROGRESS WAS TOO SLOW. HE RECOMMENDED THE SURGEON SWITCH TO CONVENTIONAL SURGERY, WHERE AN INCISION IS MADE FROM THE NAVEL TO THE PUBIC BONE TO ACCESS THE PROSTATE. AFTER THE PROCTOR LEFT THE OPERATING ROOM, THE SURGEON CONTINUED USING THE ROBOT. THE PATIENT LATER DIED FROM COMPLICATIONS." ON SEPTEMBER 29, 2009, UPON FOLLOWING UP, IT WAS DISCOVERED THAT ANOTHER DR WAS THE PROCTOR.
cause not established2955842-2009-00346Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-10-07FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2009-00363da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT TOWARD THE END OF A DA VINCI S SACRALCOPOPEXY PROCEDURE, THE CONSOLE SURGEON EXPERIENCED USER MESSAGE "LIGHTEN GRIP". THE CONSOLE SURGEON ATTEMPTED TO TROUBLESHOOT THE SYSTEM ERROR BY RELEASING THE GRIPS ON THE MASTER TOOL MANIPULATORS (MTM); HOWEVER, THE SYSTEM ERROR PERSISTED. THE CONSOLE SURGEON THEN PLACED THEIR HEAD BACK INTO THE HIGH RESOLUTION STEREO VIEWER (HSRV) LOCATED ON THE SURGEON'S CONSOLE AND ACCIDENTLY CLUTCHED AND CHANGED CONTROL OF THE PATIENT SIDE MANIPULATOR (PSM) FROM PSM 2 TO PSM 3. THE SURGEON WAS UNCLEAR WHY THE INSTRUMENT ON THE PSM 2 WAS NOT MOVING WHEN SHE NOTICED THAT SHE HAD ACCIDENTLY CLUTCHED AND GAINED CONTROL OF THE INSTRUMENT IN PSM 3. AT THIS POINT, THE SURGEON HAD ALREADY MOVED PSM 3 WITH INSTRUMENT DOWN CAUSING THE INSTRUMENT TO MAKE CONTACT AND INJURING THE PATIENT'S SACRAL. THE CASE WAS CONVERTED TO A TRADITIONAL OPEN PROCEDURE AND THE PATIENT'S INJURY WAS REPAIRED AND THE PROCEDURE WAS COMPLETED. AS OF 2009, THE PATIENT WAS REPORTED AS DOING WELL WITH NO FURTHER ISSUES.
cause not established2955842-2009-00363Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-10-05FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04969da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2009 FOR PELVIC PAIN, ENDOMETRIOSIS, AND IRREGULAR BLEEDING. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED HOSPITAL OPERATIVE, RADIOLOGY REPORTS, AND OFFICE NOTES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2009, THE PATIENT PRESENTED WITH SEVERE PAIN FOLLOWING INTERCOURSE (THE PATIENT HAD BEEN CLEARED TO RESUME THIS ACTIVITY) AND VAGINAL DISCHARGE. SHE WAS FOUND TO HAVE PARTIAL DEHISCENCE WITH EVISCERATION. ADHESIONS OF BOWEL TO CUFF NOTED. PATIENT WENT TO O.R. FOR CUFF CLOSURE. THE PATIENT REPORTED PAINFUL INTERCOURSE ON NOTES FROM (B)(6) 2010. SHE RETURNED TO THE OR FOR DIAGNOSTIC LAPAROSCOPY WITH FINDING OF VERY THIN AREA OF VAGINAL TISSUE.
cause not established2955842-2013-04969Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-09-30FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04252da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2009. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PATIENT'S STITCHES WAS CLOSED IMPROPERLY WHICH CAUSED AN INTERNAL LEAKAGE OF URINE. HE HAD EXTREME PAIN IN THE ICU. HAD A HEAT ATTACK WHICH CAUSED A BOWEL BLOCKAGE.
cause not established2955842-2013-04252Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-09-28FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03494da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON AUGUST 16TH, 2013 INTUITIVE SURGICAL, INC. RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI TOTAL HYSTERECTOMY WITH RIGHT SALPINGO-OOPHORECTOMY, LYSIS OF ADHESIONS, ABLATION OF ENDOMETRIOSIS IMPLANTS AND CYSTOSCOPY THE SURGEON'S OPERATIVE REPORT FOR THE SURGICAL PROCEDURE OF (B)(6) 2009 STATES THAT DURING THE VINCI TOTAL HYSTERECTOMY WITH RIGHT SALPINGO-OOPHORECTOMY,SIGNIFICANT SCARRING FROM THE PATIENT'S PREVIOUS SURGERY AND ENDOMETRIOSIS WERE OBSERVED. THE PATIENT'S CERVIX AND UTERUS WERE REMOVED WITHOUT COMPLICATIONS AND THE PATIENT TOLERATED THE PROCEDURE WELL. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WS DISCHARGED TO HOME THE NEXT DAY ON (B)(6) 2009. ON (B)(6) 2009, THE PATIENT PRESENTED TO HER DOCTOR'S OFFICE AND REPORTED SUDDEN ONSET OF PAIN WITH INTERCOURSE THE PREVIOUS NIGHT. EXAMINATION, PER MEDICAL CHART, SHOWED VAGINAL CUFF DEHISCENCE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SURGICAL REPAIR. THE VAGINAL
cause not established2955842-2013-03494Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-09-24FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04218da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATE CANCER PROCEDURE ON (B)(6) 2009. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'NICKED A VEIN AND AN ARTERY, INTERNAL BLEEDING. IMPOTENCE AND PAIN TO THE ABDOMEN'.
cause not established2955842-2013-04218Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-09-18FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2010-00266da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON MAY 19, 2010, A COPY OF MEDWATCH REPORT # (B)(4) WAS RECEIVED FROM THE FDA, WITH THE FOLLOWING EVENT DESCRIPTION. "VOLUN 3-APR-2010: MY OBGYN DR (B) (6) PERFORMED A ROBOTIC ASSISTED HYSTERECTOMY. THIS RESULTED IN INJURY TO BOTH URETERS. THE RIGHT URETER HAD TO BE REIMPLANTED, AND THE LEFT URETER WAS STENTED. DR (B) (6) WAS USING A MEDICAL DEVICE CALLED THE 'DA VINCI'. IT WAS SUPPOSED TO BE THE STATE OF THE ART MEDICAL DEVICE IN GYNECOLOGICAL SURGERIES. THE HOSP I WAS IN (B) (6) IN (B) (6). THE HOSPITALS THAT USE THE DA VINCI ARE SUPPOSED TO HAVE A PRIVILEGING OR CREDENTIALING SYSTEM TO DETERMINE THE REQUIREMENTS PRIOR TO PERFORMING ROBOTIC SURGERIES. I DO NOT BELIEVE THAT MY DOCTOR HAD BEEN TRAINED TO USE THIS MEDICAL DEVICE, THAT IS WHY MY INJURIES OCCURRED. ALSO, I HAVE BEEN UNABLE TO GET IN TOUCH WITH ANYONE AT (B) (6) HOSP WHO CAN TELL ME IF THIS PARTICULAR HOSP HAS SET UP A PRIVILEGING SYSTEM IN THE MATTER OF THIS MEDICAL DEVICE. I HAVE NOT BEEN ABLE TO FIND OUT IF THE HOSP HAS FOLLOWED THE REGULATIONS THAT MUST BE FOLLOWED, IN WHICH A REPORT HAS TO BE FILLED OUT WHEN A PT IS INJURED. I WILL CONTINUE TO ASK QUESTIONS FROM THE HOSP ABOUT WHAT AND WHY I WAS INJURED ON (B) (6)
cause not established2955842-2010-00266Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-09-18FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2009-00347da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT 4 DAYS POST OP, A DA VINCI SI HYSTERECTOMY PROCEDURE, A 5MM PERFORATION OF THE PT'S BOWEL WAS OBSERVED DURING A LAPAROSCOPIC COLOSTOMY PROCEDURE. IN 2009, THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFO: PRE-OPERATIVELY, THE PT EXPERIENCED COMPLICATIONS OF SEVERE BOWEL IMPACTION (HARD STOOL) THROUGHOUT THE ENTIRE LARGE INTESTINE DUE TO DIVERTICULOSIS. THE PT'S BOWEL WAS INFUSED WITH AN ENEMA AND CONTRAST ALL THE WAY TO THE CECUM TO AID IN THE MOVEMENT OF THE PT'S BOWEL. IN ADDITION, THE PT HAD A COLOSTOMY TUBE THAT PRESENTED LEAKAGE THUS CAUSING THE PT TO DEVELOP AN INFECTION. IT IS UNK HOW DAMAGE TO THE PT'S BOWEL OCCURRED; HOWEVER, THE PERFORATION MAY HAVE BEEN INTRODUCED DURING THE ENEMA AND CONTRAST PROCEDURE. THE PT REMAINS HOSPITALIZED AS OF THE SAME DAY. IN ADDITION, THE INFECTION IS UNDER CONTROL AND THE PT IS REPORTED TO BE DOING WELL.
cause not established2955842-2009-00347Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-09-16FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2010-00121da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI S THYROIDECTOMY PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS, DUE TO RADIAL NERVE DAMAGE.
cause not established2955842-2010-00121Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-09-15FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2009-00337da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE, THE SURGEON ACTIVATED THAT MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WHILE IT WAS OUT OF THEIR FIELD OF VIEW AND ACCIDENTLY LACERATED THE PATIENT'S RIGHT EXTERNAL ILIAC ARTERY. THE PLANNED SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE AND THE DAMAGE TO THE PATIENT'S ARTERY WAS REPAIRED USING A PRIMARY CLOSURE TECHNIQUE. THE PATIENT WAS REPORTED TO BE DOING WELL AND HAS NOT EXPERIENCED ANY POST OPERATIVE COMPLICATIONS.
cause not established2955842-2009-00337Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2009-09-09FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04889da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI ROBOTIC MITRAL VALVE REPAIR ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION, NAMELY HEMOPERITONEUM SECONDARY TO TRAUMA TO THE LIVER. IT IS SUSPECTED THAT PRESSURE FROM ONE OF THE ROBOTIC ARMS MAY HAVE EXCEEDED THE LIVER CAPSULES BURST PRESSURE AND A SMALL SECTION OF THE LIVER'S RIGHT LOBE OPENED ALLOWING BLEEDING TO OCCUR INTO THE ABDOMINAL CAVITY. THIS WAS HAPPENING WHILE THE ROBOTIC VALVE REPLACEMENT WAS ONGOING. HEMODYNAMIC CONCERNS DEVELOPED, THE HEMOPERITONEUM WAS RECOGNIZED AND THE ABDOMEN WAS OPENED AND THE LIVER WAS REPAIRED. CONSEQUENTLY THE PATIENT DEVELOPED SYMPTOMS OF ACUTE RENAL FAILURE AND REQUIRED HEMODIALYSIS. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.
cause not established2955842-2013-04889Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗