Find a safety record
Every incident, injury and recall on file, from the national registries that publish them. Search a maker, a model, a town or a reference number — or narrow by what happened. Each record is the registry's own text, reproduced without rewriting, with the reference that locates it at the source. Registries count different things, so a total is a count of FILINGS and never a measure of how dangerous something is. How the record was collected.
Or jump to a maker
3,136 records match for Intuitive Surgical, Inc.
310 death reports2000–20262 registriesClear
Narrow it down
What happened
Country
Year
Death reported2012-09-10FDA MAUDEda Vinci Surgical System2955842-2012-00480da 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: IT WAS REPORTED THAT POST A SUCCESSFUL DA VINCI SI MITRAL VALVE REPAIR PROCEDURE, THE PATIENT WAS UNABLE TO STABILIZE AND THE SURGEON DECIDED TO COMPLETE THE PROCEDURE VIA A THORACOTOMY. IT WAS REPORTED THAT THE PATIENT EXPIRED SHORTLY AFTER THE PROCEDURE. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SI SURGICAL SYSTEM.
cause not established2955842-2012-00480Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-07FDA MAUDEda 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 ↗Death reported2012-09-07FDA MAUDEda Vinci Surgical System2955842-2012-00422da 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 POST A SUCCESSFUL DA VINCI SI HYSTERECTOMY PROCEDURE THE PATIENT EXPIRED. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SI SURGICAL SYSTEM.
cause not established2955842-2012-00422Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-06FDA MAUDEda 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 MAUDEda 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 ↗Death reported2012-09-04FDA MAUDEda Vinci Surgical System2955842-2012-00459da 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 SI PARTIAL NEPHRECTOMY PROCEDURE DURING TUMOR REMOVAL THE PATIENT STARTED BLEEDING. IT WAS NOTICED THAT THE PATIENT'S VENA CAVA WAS RUPTURED. THE PATIENT WAS SUPPLIED BLOOD, HOWEVER THE PATIENT EXPIRED. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SI SURGICAL SYSTEM.
cause not established2955842-2012-00459Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-04FDA MAUDEda 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 ↗Death reported2012-09-04FDA MAUDEda Vinci Surgical System2955842-2014-05632da 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 WHO UNDERWENT A DA VINCI RADICAL RETROPUBIC PROSTATECTOMY FOR LOCALIZED PROSTATE CANCER ON (B)(6) 2012. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. PER THE OPERATIVE REPORT, DURING THE DISSECTION OF THE PROSTATE, COMING UP ON THE LEFT SIDE, AT THE APEX, WENT A LITTLE DEEP, AND THERE WAS A SMALL 1 CM HOLE IN THE RECTUM... THIS WAS SUBSEQUENTLY CLOSED, ...AND WE GOT AN EXCELLENT CLOSURE OF THAT TINY LITTLE HOLE. THE SURGERY CONTINUED TO COMPLETION, AND A FOLEY CATHETER WAS PLACED. THE SURGEON NOTED, THERE WAS NO BLOOD ACCUMULATION AND I WAS CONCERNED ABOUT A JACKSON-PRATT DRAINAGE WITH THE RECTUM, THAT MIGHT WORK ITS WAY THROUGH IT, SO I DECIDED NOT TO LEAVE A JACKSON-PRATT DRAIN. THE SURGEON ALSO NOTED THAT PRIOR TO EVACUATION OF CO2 FROM THE ABDOMEN, THERE WAS A LITTLE INFLATION OF SOME AIR IN THE SCROTUM, THAT WAS DECOMPRESSED. NO FURTHER INTRAOPERATIVE COMPLICATIONS WERE NOTED AND THE ESTIMATED BLOOD LOSS WAS 500 ML. AT THE CONCLUSION OF THE SURGICAL PROC
cause not established2955842-2014-05632Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2012-09-01FDA MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 ↗Death reported2012-08-28FDA MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 MAUDEda 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 ↗