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Not graded by the source2012-08-07FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04990da 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 WITH RIGHT SALPINGO-OOPORECTOMY ON (B)(6) 2012. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: SUBSEQUENT ER VISIT NOTES AND OPERATIVE REPORT OF VAGINAL REPAIR THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WERE NO INTRAOPERATIVE OR IMMEDIATE POST OPERATIVE COMPLICATIONS. ON (B)(6) 2012 THE PATIENT PRESENTED WITH SYMPTOMS OF ABDOMINAL PAIN AND VAGINAL BLEEDING AFTER INTERCOURSE. SHE HAD RESUMED SEXUAL ACTIVITY A FEW WEEKS EARLIER WITHOUT DIFFICULTY. ON THIS DAY HOWEVER, SHE WAS FOUND TO HAVE A VAGINAL CUFF DEHISCENCE WITH SMALL BOWEL SEEN IN THE UPPER VAGINA. ON (B)(6) 2012, THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE SHE UNDERWENT A LAPAROSCOPIC REPAIR OF VAGINAL CUFF DEHISCENCE WITHOUT COMPLICATION. NO FURTHER FOLLOW UP INFORMATION WAS PROVIDED.
cause not established2955842-2013-04990Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-06FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03925da 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 TOTAL BENIGN HYSTERECTOMY PROCEDURE ON (B)(6) 2012. 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 INJURIES AND DAMAGES.
cause not established2955842-2013-03925Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-06FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-01332da 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, ISI RECEIVED A LEGAL COMPLAINT ALLEGING THAT A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2012, AT (B)(6), DEVELOPED POST-SURGICAL SYMPTOMS OF ABDOMINAL PAIN AND DISTENTION, SOFT TISSUE SWELLING IN THE LOWER ABDOMEN AND LABIAL AREA, ANEMIA, NAUSEA, AND FEVER. THE LEGAL COMPLAINT ALSO ALLEGES THAT THE PATIENT WAS READMITTED TO THE HOSPITAL POST-OPERATIVELY FROM ROBOTIC SURGERY FOR REPAIR OF A BLADDER LACERATION ON (B)(6) 2012.
cause not established2955842-2013-01332Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-03FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03723da 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 HYSTERECTOMY PROCEDURE ON (B)(6) 2012, AND ALLEGED TO HAVE INJURIES INCLUDING EXTREME HEMORRHAGING AND POST-OPERATIVE TRAUMA. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
cause not established2955842-2013-03723Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-07-31FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03194da 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. RECEIVED INFORMATION INCLUDING A MEDICAL RECORDS SUMMARY OF A PATIENT THAT UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SURGICAL PROCEDURE DUE TO RECURRING PELVIC PAIN, UTERINE TENDERNESS, BILATERAL ADNEXAL TENDERNESS AND AN OVARIAN CYST. THE SURGEON ENCOUNTERED FILMY ADHESIONS IN THE BLADDER AREA WHILE PERFORMING DISSECTION. THE BLADDER WAS ADHERENT TO THE UTERINE SEGMENT. IN ADDITION, THERE WERE PERITONEAL ADHESIONS AROUND THE LOW UTERINE SEGMENT. AFTER THE UTERUS WAS REMOVED AND CLOSURE OF THE PATIENT'S VAGINAL CUFF WAS COMPLETED, A SMALL OPENING INTO THE DOME OF THE PATIENT'S BLADDER WAS NOTED. AT THAT TIME, A UROLOGIST WAS CONSULTED AND THE PATIENT'S BLADDER WAS REPAIRED INTRAOPERATIVELY. A CYSTOSCOPY POST-BLADDER CLOSURE WAS PERFORMED. DYE WAS OBSERVED FLOWING THROUGH BOTH THE RIGHT AND LEFT URETERS. THE PATIENT WAS AWAKENED AND RETURNED TO THE RECOVERY ROOM. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. DURING A ROUTINE FOLLOW-UP EXAMINATION ON (B)(6) 2012, THE PATIENT HAD SUPRAPUBIC PAINS AND RECURRENT URINARY TRACT INFE
cause not established2955842-2013-03194Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-07-30FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00360da 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) 2012, A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE, PROVIDED INTUITIVE SURGICAL INFORMATION REGARDING THEIR POSTSURGICAL EXPERIENCE. THE PATIENT INDICATED THAT APPROXIMATELY 1 WEEK AFTER THEIR PROCEDURE, ON (B)(6) 2012, THE PATIENT BECAME VERY ILL AND EXPERIENCED PAIN AND WAS ADMITTED INTO (B)(6) MEDICAL CENTER FOR A SLEEPING BOWEL. PER THE PATIENT, HER BELLY WAS FILLED WITH FLUID AND REQUIRED DRAINING. UPON RETURNING HOME THE PATIENT THREW UP, EXPERIENCED A FULL BELLY, AND CONTINUED TO FEEL ILL. THE PATIENT WAS ADVISED HER SYMPTOMS WERE A NATURAL RESPONSE TO HER PROCEDURE. ON (B)(6) 2012, THE PATIENT WAS ADMITTED INTO THE ER AND A CAT SCAN FOUND FLUID, HOWEVER NO DRAINAGE WAS PERFORMED. THE ATTENDING PHYSICIAN RELEASED THE PATIENT AND ADVISED THE PATIENT THAT THE SYMPTOMS WERE THE RESULT OF AN INFLAMMATORY CONDITION. PER THE PATIENT, ON (B)(6) 2012, ONE-LITER OF FLUID WAS DRAINED FROM HER STOMACH AND SHE WAS PRESCRIBED STEROIDS TO CONTROL THE INFLAMMATION. PER THE PATIENT, DYE TESTS PERFORMED REVEALED THAT HER URETER WAS NICKED. PER THE PATIENT A STENT WAS PLACED IN HER URETER, AN ABDOMINAL DRAIN AND CATHETER WERE PLACED TO REPAIR HER U
cause not established2955842-2012-00360Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-07-30FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04934da 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 EXTRAFASCIAL TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND PELVIC AND PARAORTIC NODE DISSECTION FOR AN UNSTAGED ADENOCARCINOMA OF THE ENDOMETRIUM ON (B)(6) 2012. IN ADDITION, THE PATIENT ALSO UNDERWENT A DIAGNOSTIC LAPAROSCOPY AND WASHINGS. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL (B)(6) 2012, HANDWRITTEN (B)(6) 2012, DISCHARGE SUMMARY (B)(6) 2012 THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. A DIAGNOSTIC LAPAROSCOPY REVEALED A BENIGN UPPER ABDOMEN, BOWEL, AND RETROPERITONEUM. THERE WAS NO OBVIOUS EVIDENCE OF EXTRAUTERINE DISEASE. THE ROBOT WAS DOCKED AND THE UTERUS WAS MOBILIZED BY ISOLATING AND DIVIDING THE BILATERAL LIGAMENTS OF THE UTERUS, THE INFUNDIBULOPELVIC LIGAMENTS AND THE PERITONEUM AROUND IT. THE URETERS WERE IDENTIFIED. THE UTEROVESICAL FOLD WAS DIVIDED AND THE BLADDER PROGRESSIVELY DISSECTED OFF THE LOWER UTERINE SEGMENT TO APPROXIMATELY 2CM BELOW THE CERVICOVAGINAL JUNCTION. AFTER COLP
cause not established2955842-2013-04934Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-07-29FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00444da 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 PATIENT'S BLADDER WAS PUNCTURED WITH A NEEDLE. THE AFFECTED AREA WAS REPAIRED AND THE PATIENT IS REPORTED TO HAVE RECOVERED OK. REPORTEDLY, DAMAGE TO THE PATIENT'S BLADDER WAS UNRELATED TO THE DA VINCI SI SYSTEM, INSTRUMENT AND/OR ACCESSORIES.
cause not established2955842-2012-00444Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-07-27FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04038da 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 SI CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2012. 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 INJURIES AND DAMAGES.
cause not established2955842-2013-04038Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-07-26FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04810da 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) 2012, THE PATIENT UNDERWENT A DA VINCI ROBOTIC HYSTERECTOMY PROCEDURE FOR CYCLIC PELVIC PAIN. 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) 2012 THE PATIENT HAD THE ROBOTIC HYSTERECTOMY PROCEDURE AND WAS DISCHARGED AFTER UNEVENTFUL STAY THE FOLLOWING DAY. ON (B)(6) 2012, THE PATIENT ARRIVED AT THE HOSPITAL WITH FEVER, MYALGIA AND PELVIC FLUID COLLECTION. CT SCAN WAS DONE AND SUGGESTED ABSCESS. THE PATIENT WAS TREATED WITH ANTIBIOTICS, SIZE DECREASING. ON (B)(6) 2012, SURGEON PERFORMED VAGINAL DRAINAGE OF ABSCESS AND IT WAS NOTED THE CUFF APPEARED TO BE INTACT. THE PATIENT WAS DISCHARGED ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT WAS READMITTED FOR PELVIC PAIN. RESUMED IV ANTIBIOTIC THERAPY AND CT SCAN PRIOR TO DISCHARGE ON (B)(6) 2012 NOTED RESOLUTION OF ABSCESS. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.
cause not established2955842-2013-04810Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-07-25FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04778da 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 (BSO) FOR FIBROIDS AND DYSMENORRHEA ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL MEDICAL RECORDS FOR THE FOLLOW UP CARE WERE PARTIALLY 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. ON (B)(6) 2012 THE PATIENT PRESENTED WITH SEVERE ABDOMINAL PAIN, NAUSEA, VOMITING, AND SOME LOW-GRADE FEVERS. SHE HAD NOTED SOME FECULENT DRAINAGE FROM HER VAGINA. IN THE EMERGENCY ROOM THERE WAS EVIDENCE OF PERITONITIS ON EXAM AND STOOL DRAINING FROM HER VAGINA. HER WHITE BLOOD CELL COUNT WAS ELEVATED AT 15, AND A CT SCAN DEMONSTRATED EVIDENCE OF PELVIC FLUID AND AN ABSCESS. ON (B)(6) 2012 THE PATIENT HAD AN EXPLORATORY LAPAROTOMY AND COLOSTOMY WITH REPAIR OF SIGNIFICANT RECTAL INJURY AND REPAIR OF VAGINAL CUFF DEHISCENCE. AREA OF PERFORATION WAS NOTED AT RECTO-SIGMOID JUNCTION. ON (B)(6) 2013, HAD SUBSEQUENT EXPLORATORY LAPAROTOMY WITH SIGMOID COLON RESECTION AND PRIM
cause not established2955842-2013-04778Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-07-23FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03527da 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. RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT ROBOTIC HYSTERECTOMY FOR FIBROID UTERUS ON (B)(6) 2012 AND WAS REPORTED TO HAVE DEVELOPED POST-OPERATIVE COMPLICATIONS. THE PATIENT UNDERWENT THE ROBOTIC ASSISTED HYSTERECTOMY ON (B)(6) 2012, WITH A MEDICALLY MANAGEABLE POST-OPERATIVE RECOVERY AND WAS DISCHARGED FROM HOSPITAL ON POST-OPERATIVE DAY 2 ((B)(6) 2012). FOLLOWING THE ROBOTIC-ASSISTED HYSTERECTOMY,THE PATIENT UNDERWENT ELECTIVE VESICOVAGINAL FISTULA REPAIR ON (B)(6) 2012. THE PATIENT WAS DISCHARGED ON (B)(6) 2012, WITH A FOLEY CATHETER TO MANAGE THE HEALING OF THE VESICOVAGINAL REPAIR. THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2012, WITH COMPLAINTS OF ABDOMINAL PAIN AND HEMATURIA WITH CLOTS. PER THE MEDICAL RECORDS, THE PATIENT WAS BROUGHT TO THE OPERATING ROOM ON (B)(6) 2012, FOR OPEN RETROPERITONEAL REPAIR OF THE VESICOVAGINAL FISTULA, REVISION OF THE VAGINAL CUFF AND CYSTOSCOPY. PROCEDURE WENT AS PLANNED WITHOUT ANY COMPLICATIONS. DURING THE POST-OPERATIVE RECOVERY PHASE, THE PATIENT DEVELOPED ABDOMINAL/FLANK AND RIGHT LEG HYPERESTHESIAS. THE PATIENT WAS TREATED WITH PAI
cause not established2955842-2013-03527Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-07-19FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04793da 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 RADICAL HYSTERECTOMY, URETEROLYSIS, PELVIC AND PARAAORTIC LYMPH NODE SAMPLING ON (B)(6) 2012. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED FOLLOW-UP CONSULTATIONS, REPORTS AND RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION ON (B)(6) 2012 THE PATIENT PRESENTED WITH RIGHT SIDED PAIN, NAUSEA, VOMITING AND FEVER. THE PATIENT ALSO COMPLAINED OF VAGINAL DISCHARGE. A CT SCAN SHOWED FLUID COLLECTIONS IN THE CULDESAC WITH SIGNS OF INFLAMMATION OR INFECTION. ON (B)(6) 2012 THE PATIENT WAS ADMITTED FOR STUDIES AND TREATMENT AND WAS STARTED ON ANTIBIOTICS. ON (B)(6) 2012 THE PATIENT UNDERWENT A CYSTOSCOPY, RETROGRADE PYELOGRAM AND ATTEMPTED DOUBLE-J STENT PLACEMENT TO RULE OUT VESICOVAGINAL FISTULA, WHICH WAS NEGATIVE. A DOUBLE-J STENT COULD NOT BE PLACED; HOWEVER, AND THERE APPEARED TO BE A URETERAL OBSTRUCTION 2-3 CM CEPHALAD FROM THE BLADDER. ON (B)(6) 2012 THE PATIENT
cause not established2955842-2013-04793Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-07-18FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03138da 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 25TH, 2013 INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE DOCUMENTATION RECEIVED STATES THAT THE PATIENT SUSTAINED AN INJURY TO HER BLADDER DURING THE SURGICAL PROCEDURE. IN REGARDS TO THE DA VINCI SI HYSTERECTOMY PROCEDURE, THE PATIENT'S MEDICAL RECORDS INDICATE THAT DURING CREATION OF THE BLADDER FLAP, IT WAS NOTED THAT THERE WAS A 5 MM INCISION MADE IN THE DOME OF THE BLADDER. THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE CYSTOTOMY WAS INADVERTENTLY MADE IN THE DOME OF THE BLADDER. THE SURGEON REQUESTED A UROLOGIST TO THE OR, BUT THE UROLOGIST DECLINED BECAUSE HE WAS NOT FAMILIAR WITH DA VINCI. THE UROLOGIST INSTRUCTED THE SURGEON TO REPAIR THE CYSTOTOMY. PER INSTRUCTIONS GIVEN BY A UROLOGIST VIA AN INTRAOPERATIVE UROLOGY CONSULT, THE SURGEON REPAIRED THE CYSTOTOMY WITH 2 LAYERS OF SUTURES. ACCORDING TO THE OPERATIVE REPORT, AFTER THE REPAIR WAS COMPLETED, THE PATIENT'S BLADDER WAS FILLED WITH 300 ML OF DILUTED INDIGO CARMINE SOLUTION AND THE REPAIR WAS FOUND TO BE WATERTIGHT. TOWARDS THE CONCLUSION OF THE SURGIC
cause not established2955842-2013-03138Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-07-16FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04817da 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 SI VINCI S TOTAL HYSTERECTOMY WITH CYSTOSCOPY FOR DYSPAREUNIA AND PROLAPSE WITH PREVIOUS HISTORY OF UTERINE ABLATION ON (B)(6) 2012. 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. CYSTOSCOPY REVEALED GOOD EFFLUX OF DYE BILATERALLY. ON (B)(6) 2012 PATIENT PRESENTED WITH VAGINAL CUFF DEHISCENCE AND BOWEL PROLAPSE. SHE UNDERWENT VAGINAL REPAIR. NO FURTHER FOLLOW UP IS AVAILABLE.
cause not established2955842-2013-04817Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-07-16FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04896da 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 PROSTATECTOMY AND CYSTECTOMY FOR INVASIVE BLADDER CANCER ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES OPERATIVE AND HOSPITAL 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) 2012 PATIENT PRESENTED WITH ROBOTIC PROSTATECTOMY, CYSTECTOMY AND BILATERAL PELVIC LYMPHADENECTOMY, AND RETROPERITONEAL LYMPHADENECTOMY, WITH ILEAL NEOBLADDER. SUBSEQUENTLY DEVELOPED NUMBNESS AND WEAKNESS IN RIGHT LEG. HAD NO PRIOR WEAKNESS IN LEG. DIAGNOSED AS A RIGHT FEMORAL NERVE PALSY, POSSIBLE RELATED TO POSITIONING FOR LENGTHY SURGERY. THEN FOLLOWED BY DR (B)(6). TEMPORALLY THE ISSUES ARE RELATED TO THE SURGERY TIME THIS PHYSICIAN NOTED. EXTENSIVE TESTING NERVES, MUSCLES, SPINAL CORD SHOW NO OTHER DISEASE PROCESS.
cause not established2955842-2013-04896Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-07-16FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04940da 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 LYSIS OF ADHESIONS, RELEASE OF RIGHT OVARY AND TUBE FROM SIDEWALL, LEFT UTEROSACRAL NERVE ABLATION, EXCISION OF ADHESIONS CONSISTENT FOR ENDOMETRIOSIS AND REMOVAL OF A PARATUBAL CYST FOR CHRONIC PELVIC PAIN, DYSMENORRHEA AND A HISTORY OF ENDOMETRIOSIS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH ALL OPERATIVE REPORTS. ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL (H&P) (B)(6) 2012, (B)(6) 2012 GASTROENTEROLOGY CONSULTATION FOR ABDOMINAL PAIN (B)(6) 2012, OR REPORT (B)(6) 2012, (B)(6) 2012, (B)(6) 2012 ; RENAL CONSULTATION FOR INCREASING CREATININE 07/30/2012, EYES, NOSE, THROAT (ENT) CONSULTATION FOR TRACHEOTOMY (B)(6) 2012, INTERNAL MEDICINE CONSULTATION FOR ELEVATED BLOOD PRESSURE (B)(6) 2012, CARDIOLOGY CONSULTATION FOR TACHYCARDIA 08/16/2012, DISCHARGE SUMMARY (B)(6) 2012 AND (B)(6) 2012. 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. A V-CARE DEVICE WAS PLACED INTRAVAGINALLY AND A PNEUMPERITONEUM CREATED THROUGH AN INC
cause not established2955842-2013-04940Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-07-13FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00414da 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 SURGICAL PROCEDURE, THE PATIENT SUSTAINED DAMAGE TO THE COLON AND BLADDER. THE DAMAGE REQUIRED AN ADDITIONAL SURGERY, WHICH WAS COMPLETED SUCCESSFULLY. NO FURTHER DETAILS HAVE BEEN PROVIDED.
cause not established2955842-2012-00414Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-07-13FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2014-01652da 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) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED (B)(4). PER THE REPORT, PATIENT HAD ELECTIVE SALPINGO-OOPHORECTOMY; FOUR WEEKS POST-OP THE PATIENT HAD SYMPTOMS OF UNCONTROLLABLE URINE LEAKAGE. ADDITIONAL SURGERY WAS PERFORMED TO REPAIR THE VAGINAL CUFF, VAGINAL FISTULA AND STENT THE LEFT URETER. ON (B)(4) 2014, ISI CONTACTED THE RISK MANAGEMENT DEPARTMENT FROM THE SITE AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT'S PRE-OPERATIVE DIAGNOSIS PRIOR TO UNDERGOING THE DA VINCI SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012 WAS PELVIC PAIN, LEFT OVARIAN CYST, AND ABNORMAL UTERINE BLEEDING. THE PROCEDURE FINDINGS WERE LEFT HYDROSALPINX, SOME OOZING NOTED ALONG RIGHT PELVIC SIDEWALL. AT THE CONCLUSION OF THE DA VINCI SURGICAL PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. SHE WAS DISCHARGED FROM THE HOSPITAL ON POST-OPERATIVE DAY 1 ((B)(6) 2012). ON (B)(6) 2012, THE PATIENT UNDERWENT A CYSTO, ATTEMPTED RETROGRADE PROCEDURE FOR COMPLAINTS OF UNCONTROLLABLE URINE LEAKAGE, URINARY INCONTINENCE, AND INCREASED VAGINAL BLEEDING. THE PROCEDURE FINDINGS INCLUDING A 1 CM LESION CEPHALAD, SLIGHTLY LATERAL TO LEFT ORIFICE THAT HAD SOME MUCOSAL EDEMA. AT THE END OF THE SURGICAL PROCEDUR
cause not established2955842-2014-01652Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-07-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03543da 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 HYSTERECTOMY WITH LEFT SALPINGO OOPHORECTOMY PROCEDURE FOR MENORRHAGIA AND UTERINE FIBROIDS ON (B)(6) 2012. PER THE OPERATIVE REPORT, THE PROCEDURE FINDINGS WERE UTERINE FIBROIDS, SCARRED CAVITY, SCARRED LEFT FALLOPIAN TUBE AND OVARY. THE PATIENT TOLERATED THE PROCEDURE WELL WITH AN ESTIMATED BLOOD LOSS OF 25 ML AND WAS TAKEN TO THE RECOVERY IN STABLE CONDITION. THE OPERATIVE REPORT DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. ON POSTOPERATIVE DAYS 0-1, THE PATIENT'S HEMOGLOBIN AND HEMATOCRIT LEVELS WERE LOW, SO SHE RECEIVED 3 UNITS OF PACKED RED BLOOD CELLS. FOLLOWING THE BLOOD TRANSFUSION, THE PATIENT CLINICALLY IMPROVED. ON POSTOPERATIVE DAY 2, THE PATIENT COMPLAINED OF ABDOMINAL PAIN. A CT SCAN WAS PERFORMED, WHICH REVEALED BILATERAL PLEURAL EFFUSIONS, ATELECTASIS, AND A 10.0 X.7.5 X 7.5 CM HEMATOMA IN THE PELVIS. GIVEN THAT THE PATIENT'S HEMOGLOBIN WAS STABLE AND THERE WAS NO EVIDENCE OF PULMONARY COMPROMISE, THE PATIENT WAS ENCOURAGED TO USE HER INCENTIVE S
cause not established2955842-2013-03543Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-07-06FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03482da 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 TRACHELECTOMY, HIGH UTEROSACRAL VAGINAL VAULT SUSPENSION, TRANSOBTURATOR SUBURETHRAL SLING AND A CYSTOSCOPY PROCEDURE ON (B)(6) 2012 WITH A PRE-OPERATIVE DIAGNOSIS OF CERVICAL VAGINAL PROLAPSE, CERVICAL PAIN AND STRESS INCONTINENCE. ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT, THE PATIENT HAS UNDERGONE A PREVIOUS HYSTERECTOMY PROCEDURE. THE PATIENT'S MEDICAL RECORDS REGARDING THIS PROCEDURE WERE NOT PROVIDED TO ISI. BASED ON THE INFORMATION IN THE PATIENT'S OP REPORT, THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRAOPERATIVE COMPLICATIONS. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND IT WAS STATED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN EXCELLENT CONDITION. REPORTEDLY, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2012 COMPLAINING OF VAGINAL BLEEDING AND ABDOMINAL PAIN. THE PATIENT WAS
cause not established2955842-2013-03482Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-30FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03071da 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 PROCEDURE ON (B)(6) 2012. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, SHE SUSTAINED A SMALL RENT/TEAR IN THE POSTERIOR WALL OF THE BLADDER. ISI HAS REVIEWED THE MEDICAL RECORDS FOR THE PATIENT. BASED ON THE OPERATIVE REPORT OF THE HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2012, THERE IS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE SURGEON INDICATED THAT AFTER CLOSING OFF THE VAGINAL CUFF WITH THE SUTURE, WE THEN PLACED INDIGO CARMINE IN THE PATIENT'S VESSELS. THE SURGEON ALSO INDICATED, WE THEN PERFORMED A CYSTOSCOPY AFTER WE REMOVED ALL THE TROCARS UNDER DIRECT VISUALIZATION. AT THE CYSTOSCOPY, BOTH URETERS WERE NOTED TO BE EJECTING INDIGO CARMINE. WE THEN SAW A SMALL LITTLE HOLE, PIN SIZE HOLE. THE OPERATIVE REPORT INDICATED THAT AN INTRAOPERATIVE CONSULT WAS PERFORMED BY A SURGEON FROM UROLOGY AND IT WAS CONFIRMED THAT THERE WAS AN INCIDENTAL CYSTOTOMY. THE PATIENT'S INCISION SITES WERE THEN REOPENED AND 2 ROBOTIC TROCARS WERE USED IN THE LATERAL PORTS AND
cause not established2955842-2013-03071Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-29FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00301da 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: THE FOLLOWING PATIENT COMMENTS WERE FOUND POSTED ON INTUITIVE SURGICAL'S MARKETING FEEDBACK PATIENT SURVEY WEBSITE CONCERNING THE OUTCOME OF THEIR DA VINCI SURGICAL PROCEDURE: I DIDN'T RECOVER AS QUICKLY AS I THOUGHT. I WASN'T FULLY PREPARED FOR THE INCONTINENCE. I ALSO DEVELOPED A LEFT HIP PAIN THAT LASTED FOR A MONTH, MAYBE MORE BECAUSE I AM STILL IN RECOVERY. DOCTORS AREN'T SURE IF THE HIP PAIN IS RELATED TO THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDE. LATE SUBMISSION OF THIS MEDWATCH REPORT IS DUE TO AN OVERSIGHT DURING REVIEW OF THE SURVEY BY ISI MARKETING.
cause not established2955842-2012-00301Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-27FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-01043da 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: THE FOLLOWING PATIENT STORY CONCERNING A DA VINCI S HYSTERECTOMY PROCEDURE WAS SUBMITTED TO INTUITIVE SURGICAL ON (B)(6) 2012 THROUGH THE (B)(4) WEBSITE: MY EXPERIENCE WAS HORRIFIC. I HAD A RADICAL HYSTERECTOMY FOR CERVICAL CANCER. MY FAMILY WAS UNSUPPORTIVE AS WELL. I WOULD NOT EVER RECOMMEND DA VINCI. AND I CERTAINLY WOULD NOT RECOMMEND THE HOSPITAL WHERE MY SURGERY WAS PERFORMED. I WAS NOT PROVIDED ANY INFORMATION ABOUT WHAT TO EXPECT. THE ADMITTING NURSES DID NOT COMPLETE ALL PAPERWORK FOR PROPER ADMITTANCE. I WAS GIVEN TOO MUCH ANESTHESIA AND NOT FULLY RECOVERED IN THE RECOVERY ROOM. WHILE STILL GROGGY FROM SURGERY I WAS ASKED ALL KINDS OF MEDICAL QUESTIONS AND DIDN'T KNOW WHAT WAS GOING ON, WHICH I THINK IS JUST RIDICULOUS OF A MEDICAL STAFF. I WAS IN ICU FOR 1 DAY AND THERE WAS A TOTAL LACK OF PRIVACY FOR URINATING ONCE THE CATHETER WAS REMOVED. AT 10 WEEKS POST SURGERY, I HAD TO HAVE SURGERY AGAIN DUE TO VAGINAL CUFF DEHISCENCE. MY RECOVERY TIME WAS DOUBLE - MY HOSPITAL BILLS WERE MORE THAN DOUBLE. THE VAGINAL CUFF DEHISCENCE WAS VERY SCARY. I WAS A GREAT AMOUNT OF PAIN FOR 6 DAYS PRIOR TO THE SECOND SURGERY. THE RECOVERY TIMES FOR BOTH SURGERIES WERE MUCH LONGER THAN ADVER
cause not established2955842-2012-01043Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-25FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03727da 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) 2012, AND ALLEGED TO HAVE INJURIES INCLUDING POST-OPERATIVE TRAUMA AND HEMORRHAGING. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
cause not established2955842-2013-03727Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-25FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04013da 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 SI ADRENELECTOMY ON (B)(6) 2012. 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 INJURIES TO HER PANCREAS AND DAMAGES THEREFROM.
cause not established2955842-2013-04013Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-22FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00291da 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 A PATIENT SUSTAINED A BOWEL INJURY WHILE UNDERGOING A DA VINCI S SURGICAL PROCEDURE.
cause not established2955842-2012-00291Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-22FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00290da 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 A PATIENT SUSTAINED A BOWEL INJURY WHILE UNDERGOING A DA VINCI S SURGICAL PROCEDURE.
cause not established2955842-2012-00290Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-20FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04814da 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 PROCEDURE ON (B)(6) 2012 FOR HIGH GRADE CERVICAL DYSPLASIA. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED IS LIMITED TO A SINGLE FOLLOW UP NOTE. 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) 2012, THE PATIENT PRESENTED WITH HEADACHE, ABDOMINAL PAIN, AND VOMITING AND WAS ADMITTED TO A LOCAL HOSPITAL. SHE WAS FOUND TO HAVE SIGNIFICANT BLOOD PRESSURE ELEVATION AND A URINARY TRACT INFECTION. SHE WAS DEHYDRATED AND TESTED POSITIVE FOR OPIATES, MARIJUANA, AND BENZODIAZEPINES. FOR THE EVALUATION OF HEADACHE, A CT SCAN OF THE HEAD WAS PERFORMED AND SHOWED A POSSIBLE MICROANEURYSM OF THE LEFT VERTEBRAL ARTERY.
cause not established2955842-2013-04814Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-19FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00338da 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 HYSTERECTOMY PROCEDURE, DAMAGE TO THE PATIENT'S BOWEL MAY HAVE OCCURRED. NO OTHER INFORMATION CONCERNING THE REPORTED EVENT HAS BEEN PROVIDED.
cause not established2955842-2012-00338Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-19FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-05000da 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 HYSTERECTOMY PROCEDURE ON (B)(6) 2012 FOR CHRONIC PELVIC PAIN. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED FOLLOW UP OPERATIVE NOTES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. REPORTEDLY, THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ACCORDING TO THE INFORMATION AS PROVIDED IN THE PATIENT'S MEDICAL RECORDS, SHORTLY AFTER UNDERGOING THE PRIMARY SURGERY, THE PATIENT COMPLAINED OF LEAKING URINE. WAS SENT BY HER GYN TO UROLOGIST AND WAS DIAGNOSED VESICOVAGINAL FISTULA. A CYSTOSCOPY CONFIRMED THE DIAGNOSIS. ON (B)(6) 2012 AND (B)(6) 2013 THE PATIENT UNDERWENT REPAIR OF FISTULA WITH VAGINAL APPROACH. THE REPAIRS FAILED AND ON (B)(6) 2013 THE PATIENT UNDERWENT A ABDOMINAL SURGICAL REPAIR OF THE FISTULA.
cause not established2955842-2013-05000Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-18FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00283da 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 IN THE (B)(6) 2008, A PATIENT UNDERWENT A DA VINCI S MITRAL VALVE REPAIR PROCEDURE. THE RECOVERY WAS QUICK AND EASY, HOWEVER, THE PATIENT ALLEGES THAT THE MITRAL VALVE REPAIR WAS NOT SUCCESSFUL AND HE STILL HAS A HEART MURMUR AND REGURGITATION OF BLOOD THROUGH THE VALVE.
cause not established2955842-2012-00283Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-15FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03517da 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 SI TOTAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012. THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS. ACCORDING TO THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD AN ENLARGED FIBROID UTERUS, SEVERE DYSMENORRHEA, EXCESSIVE MENSTRUATION OR MENOMETRORRHAGIA, RIGHT LOWER QUADRANT ABDOMINAL PAIN, CHRONIC LOW BACK PAIN AND VAGINAL PRESSURE. AFTER THE PATIENT'S UTERUS WAS REMOVED DURING THE DA VINCI SURGICAL PROCEDURE, THE SURGEON STATED IN THE OPERATIVE REPORT THAT THE VAGINAL CUFF WAS CLOSED USING 2 V-LOCK SUTURES AND WITHOUT DIFFICULTY. INDIGO CARMINE DYE WAS THEN INJECTED INTO AN IV IN ORDER TO ENSURE THAT THE PATIENT'S GENITOURINARY TRACT WAS INTACT. THERE WAS NO INTRAPERITONEAL SPILLAGE OF INDIGO CARMINE DYE AND THE FOLEY CATHETER WAS TINTED BLUE WITH GOOD URINE OUTPUT AT THE END OF THE PROCEDURE. AT THE COMPLETION OF THE PROCEDURE, THE PATIENT WAS SENT TO THE PACU IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY ON (B)(6) 2
cause not established2955842-2013-03517Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-15FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04928da 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 LEFT SALPINGO-OOPHORECTOMY, ABDOMINAL AND PELVIC ADHESIOLYSIS FOR PELVIC PAIN AND A FIBROID UTERUS, MENORRHAGIA ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL ON (B)(6) 2012; DISCHARGE INSTRUCTIONS (B)(6) 2012, WOUND/OSTOMY CONSULT ON (B)(6) 2012, CARE MANAGEMENT CONSULT ON (B)(6) 2012, GENERAL EVALUATION-PHYSICAL THERAPY ON (B)(6) 2012, REHABILITATION MEDICINE CONSULTATION ON (B)(6) 2012, INTERNAL MEDICINE CONSULTATION & CARDIOLOGY CONSULTATION ON (B)(6) 2012, DISCHARGE SUMMARY ON (B)(6) 2012 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. DUE TO THE EXTENSIVE AMOUNT OF ADHESIONS INCLUDING COLON THAT WAS ADHERED TO THE ANTERIOR ABDOMINAL WALL, INITIAL OPEN SUPRAUMBILICAL ACCESS TO THE ABDOMEN FAILED AND ACCESS WAS CREATED IN THE LUQ BY MEANS OF A VISIBLE PORT. IT TOOK AROUND 1.5 HOURS OF ADHESIOLYSIS AND TO DETACH THE SMALL BOWEL AND COLON F
cause not established2955842-2013-04928Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-13FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04773da 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 DYSMENORRHEA, MENORRHAGIA ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT . ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL NOTES, OPERATIVE 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) 2012, THE PATIENT UNDERWENT ROBOTIC HYSTERECTOMY. FOLLOWING SURGERY, DEVELOPED POSTOP FEVER, ABDOMINAL DISTENTION AND INCREASING FLUID IN THE PELVIS. ON (B)(6) 2012, THE PATIENT RETURNED TO SURGERY- DIAGNOSTIC LAPAROSCOPY CONVERTED TO OPEN LAPAROTOMY WITH SMALL BOWEL RESECTION AND PRIMARY ANASTOMOSIS FOR THROUGH AND THROUGH INJURY. THE SURGEON ALSO FELT THAT A BOWEL INJURY OCCURRED DURING THE ROBOTIC HYSTERECTOMY.
cause not established2955842-2013-04773Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-13FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00319da 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, USING DUAL SURGEON SIDE CONSOLES (SSC) THE SURGEON WORKING FROM SSC 1 EXPERIENCED RESISTANCE WHILE MANIPULATING THE MASTER TOOL MANIPULATORS (MTM) AND WHEN THE SURGEON LET GO OF THE MTMS ON THE SSC1 THE PATIENT'S ABDOMINAL WALL WAS DAMAGED. THE SITE CONTACTED ISI TECHNICAL SUPPORT ENGINEERING (TSE) FOR TROUBLE-SHOOTING ASSISTANCE. WITH THE ASSISTANCE OF THE TSE, THE SITE SWITCHED FROM DUAL SSC SETUP TO SINGLE SSC SETUP TO PROCEED WITH THE PLANNED SURGICAL PROCEDURE. RESISTANCE ON THE SSC 2 MTMS WAS NOT EXPERIENCED BY THE SURGEON. THE TSE ASKED THE INITIAL REPORTER IF THE SURGEON WORKING FROM SSC1 HAD REMOVED HEAD FROM THE HIGH RESOLUTION STEREO VIEWER (HRSV) PRIOR TO RELEASING THE HIS HANDS FROM THE MTMS; HOWEVER, THE SURGICAL STAFF WAS UNABLE TO PROVIDE THIS INFORMATION. REVIEW OF THE SITE'S SYSTEM LOG BY THE TSE FOUND RECOVERABLE SYSTEM ERROR CODE 23002 OCCURRED ON THE MTMR AT THE TIME OF THE CUSTOMER'S REPORT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED.
cause not established2955842-2012-00319Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-13FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03932da 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 PROCEDURE ON (B)(6) 2012. TYPE OF PROCEDURE WAS NOT PROVIDED. 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 INJURIES AND DAMAGES.
cause not established2955842-2013-03932Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-12FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03480da 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 AND THE MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012, WITH A PRE-OPERATIVE DIAGNOSIS OF MENORRHAGIA, LEIOMYOMATA UTERI AND COMPLEX OVARIAN MASS. ACCORDING TO THE PATIENT'S OPERATIVE (OP REPORT) THERE WERE NO ANOMALIES NOTED. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED. REPORTEDLY, AT THE END OF THE SURGICAL PROCEDURE, THE ENTIRE SURGICAL AREA WAS INSPECTED FOR HEMOSTASIS AND THERE WAS NO EVIDENCE OF BLEEDING. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS. THE PATIENT WAS TRANSFERRED TO THE PAR IN STABLE CONDITION. REPORTEDLY, DURING HOSPITALIZATION THE PATIENT COMPLAINED OF CHEST PAIN, SHORTNESS OF BREATH AND ABDOMINAL PAIN AND ON (B)(6) 2012. A CHEST CT SCAN SHOWED NO EVIDENCE OF PULMONARY EMBOLISM. ON (B)(6) 2012, THE PATIENT UNDERWENT AN ABDOMINAL AND PELVIS CT SCAN. THE CT SCAN SUGGESTED SUBCUTANEOUS EMPHYSEMA AND PNEUMOPERITONEUM WITH SMALL BO
cause not established2955842-2013-03480Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-12FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03457da 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 OF A PATIENT WHO UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2012 AND DEVELOPED POST-OPERATIVE COMPLICATIONS. ON (B)(6) 2012, THE PATIENT WAS ADMITTED FOR PERSISTENT DYSFUNCTIONAL UTERINE BLEEDING, PERSISTENT PELVIC PAIN, DYSMENORRHEA AND PROBABLE ADENOMYOSIS. THE PATIENT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE WITH PRESERVATION OF THE OVARIES ON (B)(6) 2012. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WAS NO INDICATION IN THE OPERATIVE REPORTS THAT A MALFUNCTION OCCURRED WITH THE DA VINCI SYSTEM OR INSTRUMENT. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012 IN SATISFACTORY CONDITION. ON (B)(6) 2012, THE PATIENT CONTACTED THE HOSPITAL WITH COMPLAINT OF PASSAGE OF SOME RED TISSUE IN A SMALL CLUMP. SHE HAD NO ACTIVE BLEED AT THAT TIME. SEVERAL HOURS LATER HER BLEEDING WAS HEAVY AND SHE WAS ADVISED TO COME INTO THE ER. SHE WAS TRANSFERRED TO THE HOSPITAL AND UPON ARRIVAL; THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE WITH HYPOTENSION, UNRESPONSIVENESS AND PERSISTENTLY HEAVY VAGINAL BLEEDING. ULTRASOUND WAS PERFORMED AND REVEALED AN 8X6CM CLOT AND FLUID
cause not established2955842-2013-03457Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-11FDA MAUDEAccuray2950679-2012-00001CyberKnife
CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: COMPLICATIONS WERE DESCRIBED IN A ORAL PRESENTATION (B)(6). ACCURAY PREVIOUSLY CONTACTED THE PHYSICIAN AND CONFIRMED THAT THE REPORTED COMPLICATIONS WERE NOT DUE TO A MALFUNCTION OF THE CYBERKNIFE SYS. THE PTS HAD RECEIVED PRIOR RADIOTHERAPY AND WERE UNDERGOING RE-IRRADIATION BY THE CYBERKNIFE SYS IN AN ATTEMPT TO CONTROL RECURRENT DISEASE. DUE TO THE NATURE AND EXTENT OF DISEASE, CYBERKNIFE TREATMENT WAS THE ONLY TREATMENT OPTION FOR THE PTS IN THE STUDY. THE TOXICITIES EXPERIENCED BY THE PTS ARE KNOWN TO BE ASSOCIATED WITH RE-IRRADIATION.
cause not established2950679-2012-00001AccurayRead the record ↗Not graded by the source2012-06-11FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04776da 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 ROBOTIC HYSTERECTOMY PROCEDURE FOR UTERINE ENLARGEMENT AND FIBROID TUMORS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL OPERATIVE REPORTS AND MEDICAL 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) 2012, THE PATIENT PRESENTED WITH ABDOMINAL PAIN, NAUSEA, LEFT FLANK PAIN. ADMISSION FOR OBSERVATION. CT SCAN RESULT WAS NORMAL. ON (B)(6) 2012, THE PATIENT VISITED THE ER FOR SIMILAR COMPLAINTS. CT SCAN WAS REPEATED AND SHOWED PELVIC FLUID, AND DILATED URETER. SUSPECT LEFT URETERAL TRANSECTION AND URINOMA. CYSTOSCOPY WITH LEFT RETROGRADE PYELOGRAM SHOWED A DAMAGED TRANSECTED LEFT URETER AS WELL AS AN OPEN BLADDER LACERATION. ON (B)(6) 2012, THE PATIENT WENT FOR URETERAL RE-IMPLANTATION AND BLADDER REPAIR. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.
cause not established2955842-2013-04776Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-08FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04965da 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 TOTAL HYSTERECTOMY FOR MENORRHAGIA ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL MEDICAL RECORDS WERE PROVIDED FOR HER POST OPERATIVE CARE. 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 DEVELOPED SYMPTOMS OF PNEUMONIA WITH COUGH. SHE REQUIRED HOSPITAL ADMISSION AND ICU TREATMENT. ON (B)(6) 2010 THE PATIENT PRESENTED WITH VAGINAL BLEEDING AND LEAKING FLUID AFTER INTERCOURSE. ON (B)(6) 2010 THE PATIENT UNDERWENT A VAGINAL REPAIR OF PARTIAL VAGINAL CUFF DEHISCENCE USING MULTIPLE SUTURES. NO FISTULA WAS DETECTED.
cause not established2955842-2013-04965Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-06FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04845da 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 HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY ON (B)(6) 2012 FOR UTERINE BLEEDING, PELVIC PAIN AND DYSPAREUNIA. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2012 PATIENT PRESENTED TO THE EMERGENCY ROOM WITH DIFFUSE ABDOMINAL PAIN, LEUKOPENIA AND ELEVATED LACTIC ACID. A CT SCAN DEMONSTRATED FREE AIR AND FREE FLUID IN THE PELVIS AND RIGHT SIDED HYDRONEPHROSIS. SHE WAS TAKEN TO THE OPERATING ROOM WHERE SHE WAS FOUND TO HAVE CLOT AND BLEEDING IN HER ABDOMEN, SUTURE MATERIAL AROUND THE AREA WHERE THE URETER WAS OBSTRUCTED BUT NO EVIDENCE OF A THERMAL INJURY TO THE URETER AND BRUISING OF THE COLONIC MESENTERY WITH NO INTESTINAL INJURY. THE UROLOGIST FELT THE URETERAL OBSTRUCTION WAS DUE TO SUTURE MATERIAL FROM THE VAGINAL CUFF OR THE VASCULAR PEDICLE. THE BLEEDING WAS CONTROLLED, A URETEROLYSIS AND STENT PLACEMENT WAS PERFORMED. THE URETERAL STENT WAS REMOVED 6 WEEKS LATER THEN THE PATIENT DEVELOPED A URETERAL-VAGINAL
cause not established2955842-2013-04845Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-06FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03495da 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 SI TOTAL HYSTERECTOMY WITH LEFT SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012. THE MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED AN INTRA-OPERATIVE COMPLICATION. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD PREOPERATIVE DIAGNOSIS OF CHRONIC PERSISTENT PELVIC PAIN AND OVARIAN CYST. ACCORDING TO THE OPERATIVE REPORT OF THE DA VINCI SI SURGICAL PROCEDURE, THE SURGEON STATED THAT AFTER THE UTERUS WAS REMOVED AND THE VAGINA WAS CLOSED, AN APPROXIMATELY 1.5 CM DEFECT IN THE URINARY BLADDER WAS NOTED WHICH WAS REPAIRED BY A UROGYNECOLOGIST WITH GOOD RESULTS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012, WITHOUT ANY REPORTED ONGOING COMPLICATIONS. NO MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY WAS REPORTED DURING THE DA VINCI SI SURGICAL PROCEDURE.
cause not established2955842-2013-03495Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-05FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03693da 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 HYSTERECTOMY PROCEDURE ON (B)(6) 2012 AND ALLEGED TO HAVE INJURIES INCLUDING URETER INJURY, URETEROVAGINAL FISTULA, CERVICAL ABSCESSES AND INFECTION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
cause not established2955842-2013-03693Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-06-04FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03458da 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 AND OPERATIVE REPORTS OF A PATIENT WHO UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2012. DURING THE ROBOTIC PROCEDURE IT WAS REPORTED THAT THE PATIENT SUSTAINED RIGHT URETERAL INJURY. THE PATIENT'S PRE-OPERATIVE DIAGNOSIS INCLUDED FIBROID UTERUS,MENORRHAGIA AND ANEMIA. ACCORDING TO THE REPORT, A TRANSECTED URETER WAS NOTED DURING THE PROCEDURE. THE ATTENDING UROLOGIST, REIMPLANTED THE URETER INTO THE BLADDER WITH STENT PLACEMENT AFTER UNDOCKING THE DA VINCI SYSTEM. AT THE END OF THE REIMPLANTATION A JACKSON- PRATT DRAIN WAS PLACED IN THE PELVIS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN A STABLE CONDITION. THE PATIENT WAS DISCHARGED ON (B)(6) 2012 WITH NO REPORTED ONGOING COMPLICATIONS. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE PATIENT'S CURRENT STATUS.
cause not established2955842-2013-03458Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-05-31FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04215da 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) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'DAMAGE TO URETER (CUT OR BURNED), SURGICAL CORRECTION'.
cause not established2955842-2013-04215Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-05-30FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04341da 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) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: LASER CUT SOMETHING WHICH CAUSE INTESTINES AND OTHER INTERNAL ORGANS TO FALL OUT
cause not established2955842-2013-04341Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-05-30FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03736da 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 HYSTERECTOMY PROCEDURE ON (B)(6) 2012, AND ALLEGED TO HAVE INJURIES INCLUDING A PERFORATED BOWEL, ABDOMINAL ABSCESSES, SEPTIC SHOCK, AND RESPIRATORY FAILURE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
cause not established2955842-2013-03736Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-05-23FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00224da 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 EXPERIENCED NON-INTUITIVE MOVEMENT WITH THE INSTRUMENT AND HAD TO RESEAT THE INSTRUMENT STERILE ADAPTER AND DRAPE. POST-SURGERY, THE PATIENT DEVELOPED AN INFECTION CAUSED BY A HOLE FOUND IN HER BOWEL. AS A RESULT, THE PATIENT'S BOWEL WAS RESECTED.
cause not established2955842-2012-00224Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗