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Not graded by the source2012-09-26FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04268da 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 PARTIAL HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PIECE OF UTERUS FELL DOWN AND BURNED A HOLE IN BLADDER.
cause not established2955842-2013-04268Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-25FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-02267da 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 DEMAND INDICATING THAT A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE PERFORMED ON (B)(6) 2012, EXPERIENCED POST-SURGICAL COMPLICATIONS, REQUIRING THE PATIENT TO UNDERGO SUBSEQUENT TREATMENT. THE PATIENT'S OPERATIVE REPORTS AND OTHER RELATED MEDICAL RECORDS WERE ALSO PROVIDED TO ISI. THE PATIENT'S MEDICAL RECORDS INDICATED THE FOLLOWING: THE PATIENT'S MEDICAL HISTORY AS INDICATED IN THE OPERATIVE REPORT REGARDING THE DA VINCI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE INDICATED THAT THE PATIENT EXPERIENCED CONTINUED AND WORSENING PAIN WITH HER MENSTRUAL CYCLE. THE OPERATIVE REPORT DID NOT INDICATE THAT ANY INTRA-OPERATIVE COMPLICATIONS WERE EXPERIENCED BY THE PATIENT. THE PATIENT'S UTERUS WAS REMOVED VAGINALLY AND EXCELLENT HEMOSTASIS WAS NOTED. THE PATIENT'S ABDOMINAL CAVITY WAS IRRIGATED, INSPECTED AND THERE WAS NO BLEEDING FROM ANY SITES. THERE WAS NO INDICATION IN THE PATIENT'S OPERATIVE REPORT THAT ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2013 THE PATIENT UNDERWENT
cause not established2955842-2013-02267Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-25FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical SystemMW5027084da 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: HARMONIC ACE SHEARS INSERT TIP BROKE OFF INSIDE THE PT DURING SURGICAL INTERVENTION. REASON FOR USE: ROBOTIC MYOMECTOMY TUBAL PERFUSION DX LAPAROSCOPY.
cause not establishedMW5027084Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-24FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2015-00665da 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 DISCOVERY ACTIVITY, ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE. ISI WAS PROVIDED WITH A COPY OF THE HOSPITAL'S RISK OCCURRENCE REPORT FROM THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT. THE RISK OCCURRENCE REPORT INDICATED THAT DURING THE SURGICAL PROCEDURE, AN UNPLANNED SMALL INCISION WAS MADE INTO THE PATIENT'S BLADDER. THE DEFECT TO THE PATIENT'S BLADDER WAS REPAIRED BY THE HOSPITAL'S UROLOGIST. NO ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS PROVIDED.
cause not established2955842-2015-00665Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-21FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03729da 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 SUSTAINED A THERMAL BOWEL INJURY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
cause not established2955842-2013-03729Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-21FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04936da 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 LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND ADHESIOLYSIS FOR PELVIC PAIN, OVARIAN CYST, AND MENORRHAGIA ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL (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. AFTER TRANSVAGINAL PLACEMENT OF THE RUMI AND CREATION OF A PNEUMOPERITONEUM WITH A TRANSUMBILICALLY INSERTED VERESS NEEDLE, 5 PORTS WERE INSERTED INTO THE ABDOMEN (FOUR UNDER DIRECT VISUALIZATION) AND THE ROBOT WAS DOCKED. ON INITIAL INSPECTION, ADHESIONS OF THE OMENTUM TO THE ANTERIOR ABDOMINAL WALL WERE FOUND, WHICH WERE TAKEN DOWN WITH SHARP DISSECTION, AS WELL AS ELECTROCAUTERY. THE INSPECTION REVEALED GOOD URETERS. BILATERAL LATERAL LIGAMENTS FROM THE UTERUS TO THE PELVIS WERE BURNED WITH THE PK AND CUT; THE BLADDER FLAP COMPLETED AND DISSECTED OF THE UTERUS, THE UTERINE VESSELS CLAMPED AND BURNED AND THEN AN ANTERIOR AND
cause not established2955842-2013-04936Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-20FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-01333da 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 SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012, AT (B)(6), EXPERIENCED POST-OPERATIVE COMPLICATIONS OF BILATERAL RENAL OBSTRUCTION AND ACUTE RENAL FAILURE.
cause not established2955842-2013-01333Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-19FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04808da 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 CYSTOSCOPY PROCEDURE ON (B)(6) 2012. 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 PRESENTED WITH VAGINAL BLEEDING. THE PATIENT WAS FOUND TO HAVE A SMALL SEPARATION OF THE VAGINAL CUFF WITH AN AREA OF VENOUS BLEEDING. SUTURES WERE PLACED TO STOP THE BLEEDING AND CLOSE THE VAGINAL DEFECT. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.
cause not established2955842-2013-04808Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-18FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00690da 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 AFTER A DA VINCI SI HYSTERECTOMY SURGERY THE PATIENT PRESENTED A DISTENDED ABDOMEN AND COMPLAINED OF PAIN. IMAGING WAS PERFORMED AND THE SURGICAL STAFF CONCLUDED THE PATIENT HAD A SBO (SMALL BOWEL OBSTRUCTION) AND A PORT SITE HERNIA. THE PATIENT HAD A LAPAROTOMY AND SMALL BOWEL RESECTION 1 WEEK AFTER THE ORIGINAL SURGERY AND WAS IN THE HOSPITAL 2-3 WEEKS AFTER THAT. ON (B)(6) 2012 THE SURGEON CONFIRMED THAT PATIENT IS AT HOME AND DOING WELL CURRENTLY. THIS INVESTIGATION IS STILL ONGOING AND A FOLLOW-UP MDR WILL BE GENERATED IF ADDITIONAL INFORMATION IS RECEIVED.
cause not established2955842-2012-00690Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-18FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03314da 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)(6) 2013, INTUITIVE SURGICAL, INC.(ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI PARTIAL NEPHRECTOMY PROCEDURE ON (B)(6) 2012 DUE TO A RIGHT RENAL MASS AND A POSSIBLE CYSTIC RENAL CELL. ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT THE PROCEDURE WAS COMPLEX, AND TOOK MULTIPLE HOURS TO PERFORM. AN INTRA-OPERATIVE ULTRASOUND WAS PERFORMED AND CONFIRMED THAT THE MASS WAS LOCATED DEEP INSIDE OF THE KIDNEY, WHICH REQUIRED EXTENSIVE RECONSTRUCTIVE EFFORTS. ACCORDING TO THE OP REPORT, THERE WAS NO REPORTED MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED. NO INTRA-OPERATIVE ADVERSE EVENT WAS REPORTED EITHER. THE PATIENT WAS RE-ADMITTED DUE TO LIVER LACERATION. THE MEDICAL CHARTS FOR THIS HOSPITALIZATION WERE NOT AVAILABLE, BUT IN THE DOCUMENTATION DATED (B)(6) 2012, THIS RE-ADMISSION WAS STATED. ON (B)(6), 2012 VISIT, THE PATIENT WAS REPORTEDLY IMPROVING. ON (B)(6) 2012, THE PATIENT VISITED THE DOCTOR'S OFFICE AND HE CONTINUED TO IMPROVE. THE PATIENT APPEARED WELL WITH NO OBVIOUS SIGNS OF DISTRESS. NO MEDICAL RECORDS SINCE THIS OFFICE VISIT WERE PROVIDED.
cause not established2955842-2013-03314Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-18FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-05235da 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 HYSTERECTOMY ON (B)(6) 2012. THE LEGAL DOCUMENT ALLEGES THAT DURING THE SURGICAL PROCEDURE HER URETER, VAGINA BLADDER, AND OTHER ORGANS NOT ASSOCIATED WITH THE PROCEDURE WERE NEGLIGENTLY INJURED, AND THESE INJURIES RESULTED IN THE NECESSITY OF CONTINUED FOLLOW-UP CARE, SURGICAL INTERVENTION, AND EMBARRASSING SIDE-EFFECTS. IN ADDITION, THE LEGAL DOCUMENT CLAIMS THAT THE PATIENT HAS UNDERGONE SEVERE PHYSICAL PAIN AND MENTAL ANGUISH, SUFFERED PERMANENT DEBILITATING INJURIES, INCURRED SUBSTANTIAL HOSPITAL AND MEDICAL BILLS AND RELATED COSTS, LOST WAGES, AND WILL CONTINUE TO SUFFER SUCH DAMAGES IN THE FUTURE.
cause not established2955842-2013-05235Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-18FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-02803da 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 INDICATING THAT A PATIENT WHO UNDERWENT A DA VINCI SURGICAL PROCEDURE ON (B)(6) 2012, SUSTAINED AN INTRA-OPERATIVE THERMAL BURN TO THE BLADDER, RESULTING IN A LACERATION THAT REQUIRED THE PLACEMENT OF A FOLEY CATHETER AND FURTHER HOSPITALIZATION. THE LEGAL COMPLAINT ALSO ALLEGES THAT THE PATIENT REQUIRED AN INTRA-OPERATIVE PLACEMENT OF A TRANSOBTURATOR TAPE (BLADDER SLING) WHICH CAUSED EROSION OF THE PATIENT'S VAGINAL MESH, REQUIRING THE PATIENT TO UNDERGO TWO SUBSEQUENT SURGICAL PROCEDURES. PER THE INFORMATION INDICATED IN THE LEGAL COMPLAINT, THE PATIENT CONTINUES TO SUFFER FROM CHRONIC VAGINAL PAIN AND INCONTINENCE, THUS REQUIRING THE PATIENT TO WEAR BLADDER PADS. THE PATIENT ALSO REQUIRES FURTHER BLADDER RECONSTRUCTIVE SURGERY AND URETERAL RE-IMPLANTATION. REPORTEDLY DUE TO THE INJURY SUSTAINED BY THE PATIENT DURING THE SURGICAL PROCEDURE, THE PATIENT HAS UNDERGONE AND CONTINUES TO UNDERGO MULTIPLE PAINFUL ADDITIONAL MEDICAL TESTS AND PROCEDURES, PHYSICIAN CONSULTATIONS AND ADDITIONAL SURGERIES. THE PATIENT HAS SUFFERED AND CONTINUES TO SUFFER PAIN, LOSS OF FUNCTION, EMOTIONAL DISTRESS AND PERMANENT INJUR
cause not established2955842-2013-02803Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-17FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04174da 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: URETER WAS DAMAGED.
cause not established2955842-2013-04174Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-14FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04373da 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, AND ALLEGED TO HAVE SUSTAINED A RIGHT URETER INJURY THAT REQUIRED A SURGERY TO CORRECT.
cause not established2955842-2013-04373Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-12FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03141da 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)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2012 FOR UTERINE FIBROIDS, MENORRHAGIA AND ANEMIA. ONE WEEK PRIOR TO THE DA VINCI SURGICAL PROCEDURE ((B)(6) 2012), THE PATIENT WENT TO THE EMERGENCY ROOM (ER) WITH COMPLAINTS OF GENERALIZED WEAKNESS, DIZZINESS, AND NAUSEA. FOR ONE WEEK PRIOR TO THE ER VISIT, SHE HAD HEAVY PERIOD AND PASSED SOME CLOTS. THE PATIENT'S POTASSIUM AND HEMOGLOBIN LEVELS WERE LOW. SHE RECEIVED A BLOOD TRANSFUSION AND HER REPEAT HEMOGLOBIN WAS 12 AND HER POTASSIUM WAS NORMAL. SHE WAS DIAGNOSED WITH ACUTE BLOOD LOSS ANEMIA, SYMPTOMATIC SECONDARY TO MENORRHAGIA AND HYPOKALEMIA. THE PATIENT'S CONDITION WAS OVERALL STABLE AND WAS SENT HOME THE SAME DAY. ON (B)(6) 2012, THE PATIENT UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD A MARKEDLY LARGE UTERUS (16-WEEK UTERUS WITH MULTIPLE UTERINE FIBROIDS) ALONG WITH DENSE PELVIC ADHESIONS FROM THE OMENTUM TO THE ANTERIOR ABDOMINAL WALL. THE ADHESIONS WERE LYSED WITH MONOPOLAR SCISSORS AND PK INSTRUMENT WITHOUT
cause not established2955842-2013-03141Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-11FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04948da 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 FOR UTERINE FIBROIDS, MENORRHAGIA, AND ENDOMETRIAL HYPERPLASIA ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. SUBSEQUENT OPERATIVE REPORTS AND EVALUATIONS WERE INCLUDED 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 PATIENT HAD AN UNUSUALLY DIFFICULT PROCEDURE; HOWEVER, DUE TO EXTREME OBESITY AND BMI OR(B)(6). THE OPERATION TOOK 5 HOURS AND THE UTERUS WEIGHTED OVER 500 GRAMS. ON THE DAY OF HER DISCHARGE SHE WAS FOUND TO HAVE PRE-RENAL AZOTEMIA WITH A RAPIDLY RISING CREATININE. SHE WAS TREATED MEDICALLY AND HER ACUTE RENAL FAILURE RESOLVED. ON (B)(6) 2012, THE PATIENT PRESENTED WITH COMPLAINTS OF LEAKING FLUID PER VAGINA AND UNDERWENT CYSTOSCOPY AND PLACEMENT OF A STENT. A LACERATION WAS SEEN IN THE URETER ALONG WITH A SMALL PIECE OF SUTURE NEAR THE LUMEN OF THE URETER. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THIS DATE.
cause not established2955842-2013-04948Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-10FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04308da 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 TOTAL HYSTERECTOMY AND LEFT SALPINGO-OOPHORECTOMY PROCEDURE WITH EXTENSIVE LYSIS OF ADHESIONS ON (B)(6) 2012. THE PATIENT'S PRE-OPERATIVE DIAGNOSIS WAS MENORRHAGIA, UTERINE FIBROIDS, AND HISTORY OF MODERATE CERVICAL DYSPLASIA. ACCORDING TO THE MEDICAL RECORDS PROVIDED, INFORMED CONSENT WAS OBTAINED FROM THE PATIENT PRIOR TO THE DA VINCI SI SURGICAL PROCEDURE. BASED ON THE OPERATIVE REPORT, THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED WITH NO REPORTED INTRA-OPERATIVE COMPLICATIONS. HOWEVER, DURING THE SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE SEVERE PELVIC ADHESIVE DISEASE AND ABDOMINAL ADHESIVE DISEASE WITH FINDINGS OF OMENTAL ADHESIONS TO THE ANTERIOR ABDOMINAL WALL LINING, THE RIGHT SIDE OF THE PELVIS AND ABDOMINAL WALL, AS WELL AS THE PELVIC SIDEWALLS. THE PATIENT'S LEFT TUBE AND OVARY WERE ALSO FOUND TO BE SEVERELY ADHERED TO THE LEFT PELVIC SIDEWALL. AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT WAS EXTUBATED AND TAKEN TO THE RECOVERY ROOM AWAKE, ALERT, AND IN STABLE CONDITION. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN
cause not established2955842-2013-04308Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-07FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04964da 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) 2012 FOR FIBROIDS, ABNORMAL PAP SMEAR, CHRONIC PAIN, AND PELVIC ADHESIONS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED CT SCAN, AND DISCHARGE SUMMARY FROM HOSPITAL READMISSION. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY OPERATION. THERE WAS A REMARK IN THE OPERATIVE NOTE SUGGESTING AN INTRAOPERATIVE BOWEL INJURY BUT NO ACTION WAS TAKEN. THE PATIENT WAS DISCHARGED THE DAY AFTER SURGERY BUT RETURNED TO THE HOSPITAL ON (B)(6) 2012 WITH COMPLAINTS OF FEVER, PAIN AND FOUL DISCHARGE. A CT SCAN SHOWED A PELVIC ABSCESS. SHE HAD A JACKSON PRATT DRAIN PLACED THROUGH THE VAGINA INTO THE ABSCESS CAVITY; SHE WAS GIVEN ANTIBIOTICS AND DISCHARGED ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE.
cause not established2955842-2013-04964Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-06FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03928da 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. TYPE OF PROCEDURE IS UNKNOWN. PATIENT UNDERWENT A DA VINCI PROCEDURE ON (B)(6) 2012. THE PATIENT WAS MADE AWARE THAT HIS INJURES MAY BE THE RESULT OF THE DA VINCI ON (B)(6) 2013. 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 established2955842-2013-03928Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-06FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03706da 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 SUPRACERVICAL HYSTERECTOMY WITH REMOVAL OF A RIGHT PELVIC MASS ON (B)(6) 2012. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD A PREOPERATIVE DIAGNOSIS OF UTERINE FIBROIDS, DYSMENORRHEA, MENOMETRORRHAGIA, AND PELVIC PAIN. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON STATED THAT DUE TO THE SIZE OF THE UTERUS THERE WAS DIFFICULTY VISUALIZING CLEARLY. AFTER THE UTERINE VESSELS AND BROAD LIGAMENT WERE SKELETONIZED AND DISSECTED OUT, THE SURGEON STATED THAT THE LEFT URETER WAS DESICCATED AND LIGATED. IN ADDITION, AFTER THE UTERUS WAS EXCISED OFF THE CERVIX AND THE CERVICAL STUMP WAS APPROXIMATED, THE SURGEON STATED IN THE OPERATIVE REPORT THAT ENTRY INTO THE BLADDER WAS NOTED. AFTER THE CYSTOTOMY WAS REPAIRED WITH 3-0 VICRYL SUTURES, A DIAGNOSTIC CYSTOSCOPY WAS PERFORMED AND NO EFFLUX WAS OBSERVED FROM THE LEFT URETER. A UROLOGY SURGEON ATTEMPTED UNSUCCESSFULLY TO PLACE A STENT INTO THE LEFT URETER. THE UROLOGY SURGEON THEN PROCEEDED TO REIMPLANT THE LEFT URETER TO THE BLADDER. THE UROLOGY SURGEON ALSO PLACED A DOUBLE
cause not established2955842-2013-03706Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-04FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04838da 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 RADICAL HYSTERECTOMY AND BILATERAL PELVIC LYMPHADENECTOMY WITH RIGHT PARAAORTIC LYMPH NODE BIOPSY ON (B)(6) 2012 FOR ENDOCERVICAL ADENOCARCINOMA. 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. BOTH URETERS WERE SEEN AND TRACED FROM THE PARAAORTIC AREA TO THEIR ENTRANCE INTO THE BLADDER. PARAAORTIC LYMPH NODES WERE REMOVED AS WERE ALL LYMPH NODES AROUND THE RIGHT AND LEFT EXTERNAL ILIAC ARTERIES AND VEINS. THE COMPLETE ABSENCE OF BLEEDING WAS NOTED SEVERAL TIMES IN THE OPERATIVE NOTES. THE COLPOTOMY WAS PERFORMED SLOWLY AND WITHOUT BLEEDING. IV ADMINISTRATION OF INDIGO CARMINE DID NOT REVEAL ANY POST-PROCEDURE URETER LEAKS, AND THE URETERS COULD BE SEEN PERISTALSING NORMALLY AND IN NORMAL POSITION. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION. ON (B)(6) 2012 THE PATIENT PRESENTED WITH INCONTINENCE AND THE PRESENCE OF A FISTULA DISCUSSED. SHE WAS BROUGHT BACK LATER FOR A CYST
cause not established2955842-2013-04838Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-01FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04029da 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 PROSTATECTOMY PROCEDURE ON (B)(6) 2012. THE PROVIDED INFORMATION ALLEGES THAT THE PATIENT SUSTAINED A HEMORRHAGE INJURY FOLLOWING THE DA VINCI SI PROCEDURE. THERE WAS NO SPECIFIC ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. NO OTHER INFORMATION WAS PROVIDED.
cause not established2955842-2013-04029Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-31FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-01334da 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 SI MYOMECTOMY PROCEDURE ON (B)(6) 2012 AT (B)(6) DEVELOPED POST-SURGICAL SYMPTOMS OF CHEST PAIN, DYSPNEA, ABDOMINAL PAIN, AND INTRA-ABDOMINAL PELVIC ABSCESSES. THE LEGAL COMPLAINT ALLEGES THAT THE PATIENT DEVELOPED CHEST PAIN POST-OPERATIVELY ON (B)(6) 2012. ALLEGEDLY, OXYGEN WAS ADMINISTERED TO THE PATIENT AND THE PATIENT'S CHEST PAIN WAS RELIEVED SPONTANEOUSLY AFTER 30 MINUTES. THE LEGAL COMPLAINT ALLEGES THAT ON (B)(6) 2012 A CHEST CT ANGIOGRAM (CTA) PERFORMED ON THE PATIENT SHOWED NO EVIDENCE OF PULMONARY EMBOLUS AND THAT SAME DAY THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2012, THE PATIENT ALLEGEDLY DEVELOPED SHORTNESS OF BREATH (SOB), CHEST PAIN, AND ABDOMINAL PAIN AND ON (B)(6) 2012, THE PATIENT WAS ADMITTED INTO THE HOSPITAL'S EMERGENCY ROOM DUE TO WORSENING SYMPTOMS OF SOB. ALLEGEDLY A CHEST X-RAY PERFORMED SHOWED THAT THE PATIENT HAD SMALL PLEURAL EFFUSIONS WITH ASSOCIATED ATELECTASIS. THE PATIENT WAS TREATED FOR A POSSIBLE RESPIRATORY TRACT INFECTION. ON (B)(6) 2012, THE PATIENT ALLEGEDLY DEVELOPED A RECURRENT FEVER AND ON (B)(6) 2012, AN ABDOMINAL CT PERFORMED ON
cause not established2955842-2013-01334Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-31FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00702da 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, A PATIENT POSTED THE FOLLOWING INFORMATION ON (B)(4): MY DOCTOR RECOMMENDED THE DA VINCI FOR MY HYSTERECTOMY. I AM ONLY (B)(6) BUT, ALSO NEEDED TO HAVE MY OVARIES REMOVED. I WENT IN FOR THE SURGERY AND CAME OUT ABOUT THREE HOURS LATER TO FIND OUT THAT THE DOCTOR HAD MISSED MY UTERUS AND HIT MY RECTUM. CONSIDERED A MISTAKE. SO, NOW I HAVE TO HAVE ANOTHER SURGERY ON (B)(6)2012, AND THEY WILL BE REOPENING MY C-SECTION SCAR. I THINK THE DA VINCI IS THE WORSE THING OUT THERE PEOPLE! THE DOCTORS JUST LIKE TO USE IT BECAUSE, IT IS A COOL NEW TOY FOR THEM! I AM HOPING NOW THAT THERE IS NOT TO MUCH DAMAGE FROM THE DA VINCI. I HAVE SCARS THAT I DIDN'T NEED TO HAVE AND HAD A SURGERY THAT I DIDN'T NEED TO HAVE! I WOULD NOT RECOMMEND ANYONE TO GET THE DA VINCI. I HAVE HAD A TON OF PAIN AND BECAUSE OF IT, I HAVE TO HAVE ANOTHER SURGERY! I HAVE TWO SMALL CHILDREN AND TRUSTED THAT MY DOCTOR KNEW WHAT HE WAS DOING BUT, THAT WAS COMPLETELY WRONG! SURGEONS SHOULD NOT TELL YOU THAT IT IS GOING TO BE OK AND THAT THIS IS A GREAT NEW TOOL BECAUSE, IT DOESN'T WORK AT ALL! I HAD TO HAVE ANOTHER GENERAL SURGEON COME AND CHECK TO MAKE SURE THE DA VINCI DID NOT DO A TON OF DAMAGE! DOCTORS SHOU
cause not established2955842-2012-00702Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-29FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03950da 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 S HYSTERECTOMY PROCEDURE ON (B)(6) 2012 DUE TO PAINFUL MENSTRUAL PERIODS. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT IMMEDIATELY BEGAN TO FEEL PAIN FOLLOWING THE DA VINCI S HYSTERECTOMY PROCEDURE AND HER PAIN REPORTEDLY INTENSIFIED OVER THE NEXT 2 MONTHS. THE PATIENT WAS INFORMED BY AN UNSPECIFIED PERSON THAT HER PAIN AND ACCOMPANYING DISCHARGE OF BLOOD THROUGH HER VAGINAL CANAL WAS A NORMAL SIDE EFFECT OF THE HEALING PROCESS. IN (B)(6) 2012, THE PATIENT MET WITH AN UROLOGIST WHO CONDUCTED A CT SCAN OF THE AFFECTED AREA. INITIALLY IT WAS BELIEVED THAT SHE HAD A KIDNEY STONE; HOWEVER, IT WAS DETERMINED DURING A SUBSEQUENT SURGERY ON (B)(6) 2012 THAT A STITCH WITH SUBSTANTIAL CALCIFICATION AND FOREIGN MATTER FROM THE DA VINCI SURGERY WAS ATTACHED TO HER UTERUS. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT SUSTAINED A PUNCTURED BLADDER, SEVERED URETER, BURN, AND SEVERE INTERNAL INFECTIONS FOLLOWING THE DA VINCI SURGERY. THE PATIENT ALSO HAD TO UNDERGO NUMEROUS SURGERIES, PROCEDURES, AND TREATMENTS, INCLUDING A UTERINE TRANSPLANT IN (B)(6) 2013.
cause not established2955842-2013-03950Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-28FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04050da 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 HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND/OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.
cause not established2955842-2013-04050Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-28FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00397da 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, INTUITIVE SURGICAL RECEIVED THE FOLLOWING COMMENTS VIA AN ONLINE SURVEY FROM AN UNK SOURCE CONCERNING THE OUTCOME OF A SURGICAL PROCEDURE THAT WAS PERFORMED USING THE DA VINCI SURGICAL SYSTEM. THE INFO RECEIVED IS AS FOLLOWS: "THE SCARS WERE MORE PRONOUNCED AND DID NOT HEAL AS WELL AS WITH REGULAR LAPAROSCOPIC SURGERY. IN ADDITION, THE SURGERY CAUSED A SEVERE C-DIFF INFECTION WHICH FORCED ME BACK TO THE HOSPITAL FOR THREE DAYS."
cause not established2955842-2012-00397Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-28FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00400da 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, INTUITIVE SURGICAL RECEIVED THE FOLLOWING COMMENTS VIA AN ANONYMOUS ONLINE SURVEY CONCERNING THE OUTCOME OF A SURGICAL PROCEDURE THAT WAS PERFORMED USING THE DA VINCI SURGICAL SYSTEM. THE INFORMATION RECEIVED IS AS FOLLOWS: CONTACTED (B)(6) FROM PROCEDURE.
cause not established2955842-2012-00400Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-28FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00396da 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, INTUITIVE SURGICAL RECEIVED THE FOLLOWING COMMENTS VIA AN ONLINE SURVEY FROM AN UNK SOURCE CONCERNING THE OUTCOME OF A SURGICAL PROCEDURE THAT WAS PERFORMED USING THE DA VINCI SURGICAL SYSTEM. THE INFO RECEIVED IS AS FOLLOWS: "EXPERIENCED COMPLICATIONS. URINARY STRICTURE. HAD TO HAVE 2ND SURGERY".
cause not established2955842-2012-00396Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-28FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03851da 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 REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. ACCORDING TO THE INFORMATION PROVIDED IN THE LEGAL COMPLAINT, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. REPORTEDLY, ON (B)(6) 2012, THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF CONTINUED URINE LEAKAGE. THE PATIENT UNDERWENT TESTING THAT SHOWED THAT THE PATIENT HAD SUSTAINED A RIGHT URETERAL INJURY AND AS A RESULT THE PATIENT HAD TO UNDERGO A NEPHROSTOMY PROCEDURE.
cause not established2955842-2013-03851Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-28FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00404da 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, INTUITIVE SURGICAL RECEIVED THE FOLLOWING COMMENTS VIA AN ANONYMOUS ONLINE SURVEY CONCERNING THE OUTCOME OF A SURGICAL PROCEDURE THAT WAS PERFORMED USING THE DA VINCI SURGICAL SYSTEM. THE INFORMATION RECEIVED IS AS FOLLOWS: SOME COMPLICATIONS AFTER SURGERY, RESULTED IN INTERNAL LEAKING AND RETURN TO HOSPITAL TO HAVE DRAIN AND CATHETER INSTALLED FOR FURTHER THREE WEEKS. ON THE POSITIVE SIDE I HAD VERY GOOD BLADDER CONTROL WITHIN HOURS OF CATHETER AND DRAIN REMOVAL.
cause not established2955842-2012-00404Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-28FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03462da 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 THIS LEGAL MEDIATION EFFORT ON (B)(6) 2013, INTUITIVE SURGICAL INC. RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS OF THIS PATIENT WHO SUFFERED POST COMPLICATIONS AFTER UNDERGOING A DA VINCI ROBOTIC S PYELOPLASTY PROCEDURE ON (B)(6) 2012. THE PATIENT CAME TO THE SURGERY OFFICE ON (B)(6) 2012 WITH THE COMPLAINT OF LEFT-SIDED FLANK PAIN AND PRESSURE. THE CT SCAN SHOWED LEFT SIDED HYDRONEPHROSIS AND QUESTIONABLE CROSSING VESSEL. THE PATIENT DECIDED TO PROCEED WITH ROBOT-ASSISTED PYELOPLASTY AFTER THE SURGEON EXPLAINED THE RISK OF THE PROCEDURE AND THE POSSIBILITY THAT THE SYMPTOM MAY NOT BE RESOLVED BY THE PROCEDURE. PER THE MEDICAL RECORDS, THE ROBOTIC ASSISTED PYELOPLASTY PROCEDURE ON (B)(6) 2012 WAS SUCCESSFUL. THE PATIENT HAD AN UNEVENTFUL POST-OP COURSE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. THERE IS NO EVIDENCE IN THE MEDICAL RECORDS THAT THE DA VINCI S SYSTEM MALFUNCTIONED. ON (B)(6) 2012, THE PATIENT WAS ADMITTED DUE TO THE PATIENT'S COMPLAINT OF SEVERE LEFT FLANK PAIN. CT SCAN FOUND A URINARY LEAK AT THE ANASTOMOTIC SITE AND HYDRONEPHROSIS. HIS PAIN WORSENED AFTER IV FLUIDS STARTED. A CATHETER WAS PLACED WITH THE AIM OF IMPROVING RENAL DEPRESSION, BU
cause not established2955842-2013-03462Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-24FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00439da 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 TRANSORAL ROBOTIC SURGERY(TORS) PROCEDURE, USING THE DA VINCI SI SURGICAL SYSTEM, IT WAS NOTED THAT THE PATIENT SUSTAINED A BURN ON THE LIP. THE MONOPOLAR CAUTERY INSTRUMENT WAS INSPECTED AND IT WAS NOTICED THAT THERE WAS A WEAK AREA IN THE BLACK INSULATION. IT IS BELIEVED THIS AREA MAY HAVE CAUSED ENERGY TO BE RELEASED, AND MAY HAVE CAUSED THE BURN. THE PATIENT WAS TREATED USING OINTMENT AND IS EXPECTED TO MAKE A FULL RECOVERY.
cause not established2955842-2012-00439Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-23FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03131da 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 A SUMMARY OUTLINE OF THE PATIENT'S MEDICAL RECORDS AND INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE AND LYSIS OF ADHESIONS PROCEDURE ON (B)(6) 2012. NO COMPLICATIONS DURING THE PROCEDURE WERE NOTED TO HAVE OCCURRED. ON (B)(6) 2012 THE PATIENT WAS ADMITTED THROUGH THE HOSPITAL'S EMERGENCY ROOM WITH COMPLETE VAGINAL PROLAPSE. ON (B)(6) 2013 THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY PROCEDURE WITH THE DA VINCI SURGICAL SYSTEM AND IT WAS FOUND TO HAVE MULTIPLE INTESTINAL ADHESIONS, A PELVIC ABSCESS AND VAGINAL CUFF DEHISCENCE. THE SURGICAL PROCEDURES PERFORMED INCLUDED ENTEROLYSIS-LYSIS OF THE ADHESIONS, EVACUATION OF THE ABSCESS, AND REPAIR OF THE VAGINAL CUFF DEHISCENCE. THE PATIENT'S APPENDIX AND SMALL BOWEL WERE ALSO INSPECTED BY A UROLOGIST CONSULTANT AND AT THE TIME OF THE SURGICAL PROCEDURE AND IT WAS REPORTEDLY DETERMINED BY THE SURGEON THAT NO OTHER PROCEDURES WERE REQUIRED. THE PROCEDURE WAS COMPLETED AND THERE WERE NO COMPLICATIONS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. IT WAS NOTED IN THE PATIENT'S DISCHARGE SUMMARY
cause not established2955842-2013-03131Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-23FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04026da 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 5, 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 A THERMAL BURN INJURY TO THE PATIENT'S URETHRA. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
cause not established2955842-2013-04026Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-22FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03555da 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 AND MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO OOPHORECTOMY PROCEDURE ON (B)(6) 2012, FOR CHRONIC PELVIC AND ABDOMINAL PAIN AND ENDOMETRIOSIS. THE PATIENT STARTED TO HAVE PELVIC AND ABDOMINAL PAIN WHEN SHE WAS DIAGNOSED WITH ENDOMETRIOSIS 10 YEARS PRIOR TO THE DA VINCI SURGICAL PROCEDURE. HER PELVIC PAIN AND ABDOMINAL PAIN STARTED TO WORSEN 3 WEEKS PRIOR TO THE DA VINCI PROCEDURE. THE PATIENT HAD CONSTANT LOWER ABDOMINAL PAIN, LOW BACK PAIN, IRREGULAR MENSES AND BLEEDING BETWEEN HER PERIODS AS WELL. SHE ALSO HAD BLOOD STOOLS FOR THE 6 MONTHS PRIOR TO THE DA VINCI SURGICAL PROCEDURE. THE MEDICAL RECORD NOTED THAT THE RISKS, BENEFITS, AND ALTERNATIVES TO THE DA VINCI SURGICAL PROCEDURE WERE DISCUSSED WITH THE PATIENT. THE RISKS DISCUSSED INCLUDED BUT WERE NOT LIMITED TO BLEEDING, INFECTION, GASTROINTESTINAL/GENITOURINARY INJURY, RISK OF INJURY, RISK OF DEEP VEIN THROMBOSIS, AND THE RARE COMPLICATION OF DEATH. THE PATIENT UNDERSTOOD AND WISHED TO PROCEED WITH THE PROCEDURE. PER THE OPERATIVE REPORT FOR THE (B)(6) 2012 DA VINCI SURGICAL PROCEDURE,
cause not established2955842-2013-03555Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-22FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00442da 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 DAVINCI SI HYSTERECTOMY PROCEDURE, A BOWEL LACERATION OCCURRED; THE LACERATION WAS REPAIRED.
cause not established2955842-2012-00442Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-22FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03731da 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 POSTOPERATIVE TRAUMA AND VAGINAL ABSCESSES. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
cause not established2955842-2013-03731Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-22FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03195da 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 RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2012 FOR EXCESSIVE CRAMPING AND HEAVY BLEEDING. THE PATIENT HAD BEEN EXPERIENCING VAGINAL BLEEDING SINCE THE BIRTH OF HER CHILD IN 2001. IN 2008, THE PATIENT HAD AN ABLATION OF THE UTERUS TO HELP STOP THE BLEEDING BUT THE HEAVY BLEEDING PERSISTED. THE PATIENT OPTED FOR A HYSTERECTOMY. THE PATIENT WAS INFORMED THAT BECAUSE OF HER HISTORY OF 3 CESAREAN SECTIONS, HER BLADDER MAY POSSIBLY TEAR DURING THE SURGICAL PROCEDURE IF IT WAS ADHERING TO HER UTERUS. ON (B)(6) 2012, THE PATIENT UNDERWENT A DA VINCI S HYSTERECTOMY, LYSIS OF ADHESIONS AND CYSTOSCOPY PROCEDURE. ADHESIONS WERE NOTED OF THE OMENTUM TO THE ANTERIOR ABDOMINAL WALL INFERIOR TO THE UMBILICUS. THE ADHESIONS WERE LYSED. THERE WERE ALSO SIGNIFICANT ADHESIONS OF THE BLADDER TO THE UNDERLYING CERVIX AND LOWER UTERINE SEGMENT. IT WAS ALSO NOTED THAT THERE WAS NO ENTRAPMENT OF ABDOMINAL CONTENTS NOTED AT UMBILICAL DEFECT FASCIAL CLOSURE. DURING THE PROCEDURE, ACCORDING TO THE OPERATIVE REPORT, THE SURGEON NOTED A LEFT INGUINAL HERNIA AS C0
cause not established2955842-2013-03195Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-22FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03509da 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 HYSTERECTOMY ON (B)(6) 2012. THE MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD PREOPERATIVE DIAGNOSIS OF A SYMPTOMATIC FIBROIDS AND MENORRHAGIA. NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED IN THE OPERATIVE REPORT FOR THE DA VINCI SI SURGICAL PROCEDURE. AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT WAS SENT TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. THE POST-OPERATIVE COURSE OVERALL WAS REMARKABLE WITH SOME MINOR GI DYSFUNCTION. ON (B)(6) 2012, THE PATIENT WAS EVALUATED FOR REPORTED COMPLAINTS OF SEVERE ABDOMINAL PAIN, ABDOMINAL DISTENSION, NAUSEA, AND VOMITING. A CT SCAN OF THE PATIENT'S ABDOMEN AND PELVIS WITH CONTRAST REVEALED A URINOMA, MILD INFLAMMATION OF THE CENTRAL PELVIS, TRACE AMOUNTS OF ASCITES, RIGHT-SIDED HYDRONEPHROSIS, AND BILATERAL PLEURAL EFFUSION AND LOWER LOBE COMPRESSIVE ATELECTASIS. ON (B)(6) 2012, THE PATIENT UNDERWENT A CYSTOSCOPY, RIGHT RETROGRADE PYELOGRAPH, AND CT SCAN OF THE PATIENT'S PELVIS
cause not established2955842-2013-03509Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-21FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00460da 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: AFTER A SUCCESSFUL DA VINCI S HYSTERECTOMY PROCEDURE THE PATIENT SUFFERED BLEEDING FROM THE DRAIN. THEN THE DOCTOR DECIDED TO CONFIRM THE BLEEDING BY TRADITIONAL LAPAROSCOPIC PROCEDURE. THE DOCTOR OBSERVED THAT THE BLEEDING HAD ALREADY STOPPED, BUT THE DOCTOR TREATED THE SUSPECTED AREA WITH COAGULATION. THE PATIENT WAS DOING WELL AFTER THIS PROCEDURE, AND DISCHARGED ON SCHEDULE (B)(6). THERE WAS NO REPORTED MALFUNCTION OF DA VINCI SYSTEM, INSTRUMENTS OR ACCESSORIES.
cause not established2955842-2012-00460Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-21FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04994da 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 LOW ANTERIOR RESECTION AND CHOLECYSTECTOMY FOR CHRONIC DIVERTICULITIS AND GALLBLADDER DYSFUNCTION ON (B)(6) 2012. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP NOTES AND OPERATIVE REPORTS. 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 . ON (B)(6) 2012 PATIENT PRESENTED WITH ABDOMINAL PAIN AND FEVER. SHE WAS FELT TO BE SEPTIC WITH ENTEROCOCCUS. CT SCAN SHOWED POSSIBLE ABSCESS AND ANASTOMOSIS LEAK. THE PATIENT WAS TREATED WITH ANTIBIOTICS INTERVENTIONAL RADIOLOGY DRAINED INFECTION. THE PATIENT IMPROVED AND DISCHARGED (B)(6) 12.
cause not established2955842-2013-04994Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-21FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03148da 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 RECEIVED INFORMATION INCLUDING MEDICAL RECORDS, OF A PATIENT WHO DEVELOPED POST- SURGICAL COMPLICATIONS AFTER HAVING A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012 TO TREAT ENDOMETRIOSIS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. THE PATIENT'S PROCEDURE WENT AS PLANNED WITHOUT ANY COMPLICATIONS. THE PATIENT WAS DISCHARGED AND WAS READMITTED TO THE HOSPITAL ON (B)(6 )2012 WITH LOWER ABDOMINAL PAIN, CHILLS, FEVER AND BLOODY DISCHARGE. TEST RESULTS REVEALED THAT THE PATIENT HAD A VERY HIGH WHITE BLOOD CELL COUNT INDICATIVE OF INFECTION. THE PATENT'S PELVIC EXAM DEMONSTRATED A SLIGHT BLOODY DISCHARGE FROM THE VAGINA, NO PALPABLE PELVIC MASS WAS DETECTED. NO CLEAR SIGNS OF ABCESS AND INFECTION WERE REPORTED. THE PATIENT WAS STARTED ON IV ANTIBIOTICS AND REMAINED IN THE HOSPITAL FOR FIVE DAYS. SHE WAS DISCHARGED HOME ON ORAL AUGMENTIN AND FLAGYL. ON (B)(6) 2012 THE PATIENT DEVELOPED A FEVER OF 102. THE PATIENT WAS ADMITTED IN THE HOSPITAL FOR FURTHER MANAGEMENT. AT THE HOSPITAL SHE STAYED AFEBRILE, AND HAD LEUKOCYTOSIS OF 19.5 ON ADMISSIO
cause not established2955842-2013-03148Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-20FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03313da 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 HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL COMPLAINT ALLEGED THAT DURING THE SURGICAL PROCEDURE, THE PATIENT'S URETER, VAGINA, AND BLADDER, AND OTHER ORGANS NOT ASSOCIATED WITH THE PROCEDURE WERE NEGLIGENTLY INJURED. THE LEGAL COMPLAINT ALSO ALLEGED THAT THE INJURIES RESULTED IN THE NECESSITY OF CONTINUED FOLLOW-UP CARE, SURGICAL INTERVENTION, AND EMBARRASSING SIDE-EFFECTS. THE DETAILS OF THE PATIENT'S INJURIES AND SURGICAL INTERVENTION WERE NOT PROVIDED.
cause not established2955842-2013-03313Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-16FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04982da 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 RADICAL HYSTERECTOMY WITH ASSOCIATED LYMPHADENECTOMIES PROCEDURE ON (B)(6) 2012 FOR STAGE B1 SQUAMOUS CELL CA CERVIX. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES ADDITIONAL OPERATIVE REPORTS AND 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. THE PATIENT'S ORIGINAL OPERATION APPEARED TO HAVE NO IMMEDIATE COMPLICATION. ON (B)(6) 2012, THE PATIENT UNDERWENT CYSTOSCOPY, RETRO PYELOGRAM, LEFT STENT PLACEMENT FOR URINARY LEAKING. ON (B)(6) 2012, A NEPHROSTOMY TUBE WAS PLACED. ON (B)(6) 2012, THE NEPHROSTOMY TUBE WAS REPLACED. ON (B)(6) 2013, THE RIGHT URETER WAS STENTED WITH CONTINUED LEAKING. ON (B)(6) 2013, THE PATIENT UNDERWENT BILATERAL FISTULA REPAIRS WITH NEOCYSTOSTOMIES. ON (B)(6) 2013, HER STENTS WERE REMOVED. ON (B)(6) 2013, IV PYELOGRAM SHOWED NO OBSTRUCTION ALTHOUGH THE PATIENT HAD RECENTLY HAD PYELONEPHRITIS.
cause not established2955842-2013-04982Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-14FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03505da 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 AND INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012. THE MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED POST-OPERATIVE COMPLICATIONS. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD A PREOPERATIVE DIAGNOSIS OF PELVIC PAIN AND DYSFUNCTIONAL UTERINE BLEEDING. ACCORDING TO THE OPERATIVE REPORT OF THE DA VINCI SI SURGICAL PROCEDURE, NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED. THE SURGEON STATED THAT THE VAGINAL CUFF WAS CLOSED USING A V-LOCK 180 IN A RUNNING FASHION AND HEMOSTASIS WAS ASSURED. IN ADDITION A SHEET OF INTERCEED, AN ABSORBABLE ADHESION BARRIER, WAS PLACED OVER THE VAGINAL CUFF. A CYSTOSCOPY WAS ALSO PERFORMED TOWARDS THE END OF THE PROCEDURE AND NO EVIDENCE OF AN INJURY OR BLEEDING WAS OBSERVED. AFTER COMPLETION OF THE PROCEDURE, THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR REPORTED COMPLAINTS OF CHEST PAIN, SHORTNESS OF BREATH, AND LEFT CALF PAIN. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) OF THE PATIENT'
cause not established2955842-2013-03505Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-14FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04023da 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 SUSTAINED A TORN BLADDER. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
cause not established2955842-2013-04023Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-08FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-04258da 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 PARTIAL HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: BLOOD VESSELS DAMAGED DURING THE SURGERY, DEVELOPED RAYNAUDS DISEASE. PATENT WAS NOT ALLOWED TO HAVE CAFFEINE AND HAS TO WEAR MITTENS AROUND HER HOUSE.
cause not established2955842-2013-04258Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-07FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03133da 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 RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI TRACHELECTOMY PROCEDURE FOR REMOVAL OF HER CERVIX AND ATTACHED UTERINE TISSUE ON (B)(6) 2012. ON (B)(6) 2012 THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM COMPLAINING OF ABDOMINAL PAIN. THE OPERATIVE REPORT REGARDING THE SURGERY ON (B)(6) 2012 INDICATED THAT THE PATIENT UNDERWENT A DA VINCI SI TRACHELECTOMY PROCEDURE WITH EXTENSIVE LYSIS OF ADHESIONS FOR THE MANAGEMENT OF ENDOMETRIAL HYPERPLASIA IN THE PATIENT'S RESIDUAL UTERINE STUMP AFTER A PREVIOUS SUBTOTAL HYSTERECTOMY. BASED ON THE INFORMATION INDICATED IN THE PATIENT'S OP REPORT, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRAOPERATIVE COMPLICATIONS. HEMOSTASIS WAS ACHIEVED AFTER CLOSURE OF THE VAGINAL CUFF WAS COMPLETED. THE INITIAL PATHOLOGICAL EVALUATION OF THE RESIDUAL STUMP SUGGESTED THAT THERE WAS EVIDENCE OF HYPERPLASIA. AFTER THE PROCEDURE WAS COMPLETED, BLOOD WAS MOPPED FROM THE PATIENT'S PELV
cause not established2955842-2013-03133Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-08-07FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-03153da 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 OF A PATIENT THAT UNDERWENT A DA VINCI S RADICAL PROSTATECTOMY WITH BILATERAL PELVIC LYMPH NODE DISSECTION PROCEDURE ON (B)(6) 2012. THE PATIENT HAD A HISTORY OF PSA WITH SUBSEQUENT DIAGNOSIS OF ADENOCARCINOMA OF THE PROSTATE. DURING THE PATIENT'S POST-OPERATIVE RECOVERY, IT WAS NOTED THAT THE PATIENT HAD RECTAL BLEEDING. A RECTAL EXAMINATION AND PROCTOSCOPY SHOWED THAT THE PATIENT HAD SUSTAINED A SMALL RECTOTOMY. THE PATIENT WAS IMMEDIATELY TAKEN BACK INTO THE OR TO REPAIR THE INJURY. ISI'S REVIEW OF THE PATIENT'S OPERATIVE (OP) REPORT RELATED TO THE PATIENT'S DA VINCI S PROSTATECTOMY PROCEDURE FOUND NO ANOMALIES OCCURRED DURING THE SURGICAL PROCEDURE. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. A GENERAL SURGEON WAS CONSULTED TO REPAIR THE DAMAGE TO THE PATIENT'S RECTUM. THE DAMAGE TO THE PATIENT'S RECTUM WAS REPAIRED USING THE DA VINCI SURGICAL SYSTEM. A TWO LAYERED CLOSURE WAS PERFORMED TO REPAIR THE AFFECTED AREA. THE PATIENT'S RECTUM WAS INSPECTED AF
cause not established2955842-2013-03153Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗