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Death reported2012-08-28FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00443da Vinci Surgical System
da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE THE SURGEON EXPERIENCED VISUALIZATION PROBLEMS DUE TO THE PATIENT'S ANATOMY ON (B)(6) 2008. AFTER SEVERAL HOURS THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PROSTATECTOMY. DURING THE OPEN PORTION OF THE PROSTATECTOMY PROCEDURE A RECTAL LACERATION WAS DISCOVERED, AND A SPECIALIST WAS CALLED IN TO PERFORM AN EMERGENCY REPAIR. IT WAS REPORTED THAT BLOOD LOSS DURING THE PROCEDURE WAS ESTIMATED AT 3500CC, FLUID REPLACEMENT WAS 7500ML CRYSTALLOID, FOUR UNITS OF PACKED RED CELLS, AND ONE UNIT OF AUTOGOUS BLOOD. IT WAS REPORTED THAT ON (B)(6) 2008 THE PATIENT WAS TRANSPORTED BY AMBULANCE TO AN INTENSIVE CARE UNIT. ON (B)(6) 2008 THE PATIENT WAS TRANSFERRED TO A REHABILITATION CENTER. ON (B)(6) 2012 ISI BECAME AWARE THAT THE PATIENT EXPIRED FROM CARDIAC ARREST ON (B)(6) 2012.
cause not established2955842-2012-00443Intuitive 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 ↗Death reported2012-08-27FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2012-00435da Vinci Surgical System
da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT APPROXIMATELY 2 WEEKS POST A DA VINCI SI HYSTERECTOMY PROCEDURE, THE PATIENT DEVELOPED A PULMONARY EMBOLISM AND EXPIRED.
cause not established2955842-2012-00435Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Death reported2012-08-27FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-05408da Vinci Surgical System
da Vinci Surgical System — Death 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 PROSTATECTOMY FOR PROSTATE CANCER ON (B)(6) 2012. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT'S URETHRA WAS CUT, ADDITIONAL SURGERY WAS REQUIRED, AND THE PATIENT PASSED AWAY FROM SEPTIC SHOCK ON (B)(6) 2012. INTUITIVE SURGICAL, INC. (ISI) WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY PATIENT MEDICAL RECORDS. BASED ON THE LEGAL DOCUMENT PROVIDED, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE.
cause not established2955842-2013-05408Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Death reported2012-08-27FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2016-00480da Vinci Surgical System
da Vinci Surgical System — Death 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-ASSISTED MITRAL VALVE REPAIR PROCEDURE ON (B)(6) 2012 FOR A HISTORY OF ATRIAL FIBRILLATION AND MITRAL STENOSIS. ISI WAS NOT PROVIDED WITH THE DA VINCI OPERATIVE REPORT. BASED ON THE LEGAL DOCUMENTS PROVIDED BY THE PLAINTIFF'S ATTORNEY, THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY OCCURRED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. THE PLAINTIFF'S ATTORNEY CLAIMS THAT DURING THE SURGICAL PROCEDURE, THE SURGEON ALLEGEDLY CAUSED A TEAR TO THE DOME OF THE LEFT ATRIUM, CAUSING SEVERE PERMANENT LUNG DAMAGE AND DEATH ON (B)(6) 2012. ACCORDING TO THE LEGAL DOCUMENTS PROVIDED, THE PATIENT PASSED AWAY FROM ADULT RESPIRATORY DISTRESS SYNDROME DUE TO MITRAL STENOSIS. THE PLAINTIFF'S ATTORNEY ALSO ALLEGES THAT THE SURGEON FAILED TO CONVERT TO OPEN SURGERY AFTER HE CAUSED THE TEAR TO THE ATRIUM. NO FURTHER INFORMATION WAS PROVIDED.
cause not established2955842-2016-00480Intuitive 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 ↗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 ↗Death reported2012-08-05FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2014-01386da Vinci Surgical System
da Vinci Surgical System — Death 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 TUMOR REMOVAL IN THE PANCREAS PROCEDURE WITH THE DA VINCI SURGICAL SYSTEM ON (B)(6) 2012. REPORTEDLY, THE PATIENT SUSTAINED A BURN INJURY TO HER DUODENAL VEIN. THE PATIENT WAS AIRLIFTED TO ANOTHER HOSPITAL AND SUBSEQUENTLY DIED. NO OTHER INFORMATION WAS PROVIDED.
cause not established2955842-2014-01386Intuitive 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 ↗Death reported2012-07-06FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2013-01545da Vinci Surgical System
da Vinci Surgical System — Death 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 RECEIVED A LEGAL COMPLAINT ALLEGING THAT A PATIENT WHO UNDERWENT A DA VINCI SI SURGICAL PROCEDURE ON (B)(6) 2012, EXPIRED ON (B)(6) 2012. THE LEGAL COMPLAINT ALLEGES THAT FROM (B)(6) 2012, THE PATIENT REQUIRED CARE AND TREATMENT.
cause not established2955842-2013-01545Intuitive 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 ↗