da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATE CANCER PROCEDURE ON (B)(6) 2009. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'NICKED A VEIN AND AN ARTERY, INTERNAL BLEEDING. IMPOTENCE AND PAIN TO THE ABDOMEN'.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON MAY 19, 2010, A COPY OF MEDWATCH REPORT # (B)(4) WAS RECEIVED FROM THE FDA, WITH THE FOLLOWING EVENT DESCRIPTION. "VOLUN 3-APR-2010: MY OBGYN DR (B) (6) PERFORMED A ROBOTIC ASSISTED HYSTERECTOMY. THIS RESULTED IN INJURY TO BOTH URETERS. THE RIGHT URETER HAD TO BE REIMPLANTED, AND THE LEFT URETER WAS STENTED. DR (B) (6) WAS USING A MEDICAL DEVICE CALLED THE 'DA VINCI'. IT WAS SUPPOSED TO BE THE STATE OF THE ART MEDICAL DEVICE IN GYNECOLOGICAL SURGERIES. THE HOSP I WAS IN (B) (6) IN (B) (6). THE HOSPITALS THAT USE THE DA VINCI ARE SUPPOSED TO HAVE A PRIVILEGING OR CREDENTIALING SYSTEM TO DETERMINE THE REQUIREMENTS PRIOR TO PERFORMING ROBOTIC SURGERIES. I DO NOT BELIEVE THAT MY DOCTOR HAD BEEN TRAINED TO USE THIS MEDICAL DEVICE, THAT IS WHY MY INJURIES OCCURRED. ALSO, I HAVE BEEN UNABLE TO GET IN TOUCH WITH ANYONE AT (B) (6) HOSP WHO CAN TELL ME IF THIS PARTICULAR HOSP HAS SET UP A PRIVILEGING SYSTEM IN THE MATTER OF THIS MEDICAL DEVICE. I HAVE NOT BEEN ABLE TO FIND OUT IF THE HOSP HAS FOLLOWED THE REGULATIONS THAT MUST BE FOLLOWED, IN WHICH A REPORT HAS TO BE FILLED OUT WHEN A PT IS INJURED. I WILL CONTINUE TO ASK QUESTIONS FROM THE HOSP ABOUT WHAT AND WHY I WAS INJURED ON (B) (6)

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT 4 DAYS POST OP, A DA VINCI SI HYSTERECTOMY PROCEDURE, A 5MM PERFORATION OF THE PT'S BOWEL WAS OBSERVED DURING A LAPAROSCOPIC COLOSTOMY PROCEDURE. IN 2009, THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFO: PRE-OPERATIVELY, THE PT EXPERIENCED COMPLICATIONS OF SEVERE BOWEL IMPACTION (HARD STOOL) THROUGHOUT THE ENTIRE LARGE INTESTINE DUE TO DIVERTICULOSIS. THE PT'S BOWEL WAS INFUSED WITH AN ENEMA AND CONTRAST ALL THE WAY TO THE CECUM TO AID IN THE MOVEMENT OF THE PT'S BOWEL. IN ADDITION, THE PT HAD A COLOSTOMY TUBE THAT PRESENTED LEAKAGE THUS CAUSING THE PT TO DEVELOP AN INFECTION. IT IS UNK HOW DAMAGE TO THE PT'S BOWEL OCCURRED; HOWEVER, THE PERFORATION MAY HAVE BEEN INTRODUCED DURING THE ENEMA AND CONTRAST PROCEDURE. THE PT REMAINS HOSPITALIZED AS OF THE SAME DAY. IN ADDITION, THE INFECTION IS UNDER CONTROL AND THE PT IS REPORTED TO BE DOING WELL.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI S THYROIDECTOMY PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS, DUE TO RADIAL NERVE DAMAGE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE, THE SURGEON ACTIVATED THAT MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WHILE IT WAS OUT OF THEIR FIELD OF VIEW AND ACCIDENTLY LACERATED THE PATIENT'S RIGHT EXTERNAL ILIAC ARTERY. THE PLANNED SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE AND THE DAMAGE TO THE PATIENT'S ARTERY WAS REPAIRED USING A PRIMARY CLOSURE TECHNIQUE. THE PATIENT WAS REPORTED TO BE DOING WELL AND HAS NOT EXPERIENCED ANY POST OPERATIVE COMPLICATIONS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI ROBOTIC MITRAL VALVE REPAIR ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION, NAMELY HEMOPERITONEUM SECONDARY TO TRAUMA TO THE LIVER. IT IS SUSPECTED THAT PRESSURE FROM ONE OF THE ROBOTIC ARMS MAY HAVE EXCEEDED THE LIVER CAPSULES BURST PRESSURE AND A SMALL SECTION OF THE LIVER'S RIGHT LOBE OPENED ALLOWING BLEEDING TO OCCUR INTO THE ABDOMINAL CAVITY. THIS WAS HAPPENING WHILE THE ROBOTIC VALVE REPLACEMENT WAS ONGOING. HEMODYNAMIC CONCERNS DEVELOPED, THE HEMOPERITONEUM WAS RECOGNIZED AND THE ABDOMEN WAS OPENED AND THE LIVER WAS REPAIRED. CONSEQUENTLY THE PATIENT DEVELOPED SYMPTOMS OF ACUTE RENAL FAILURE AND REQUIRED HEMODIALYSIS. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE; HOWEVER, THE DATE OF THE PROCEDURE WAS NOT PROVIDED. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURED BLADDER AND BLOOD VESSELS.

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 ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, PELVIC AND PERIAORTIC LYMPHADENECTOMY PROCEDURE ON (B)(6) 2009 FOR STAGE-1 SQUAMOUS CELL CARCINOMA OF THE CERVIX AND ADENOCARCINOMA OF THE ENDOMETRIUM. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED: TWO DISCHARGE SUMMARIES AND THE ENCOUNTER REPORT AT READMISSION. 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 ABDOMINAL PART OF THE OPERATION WAS INITIATED WITH CREATING A PNEUMOPERITONEUM USING THE VERESS NEEDLE. DISSECTION OF THE LATERAL LIGAMENTS, MOBILIZATION OF THE OVARIES AND DIVISION OF ARTERIES WAS CARRIED OUT USING CAUTERY INSTRUMENTS. THE UTERUS WAS RESECTED CIRCUMFERENTIALLY WITH ELECTROCAUTERY, THE SPECIMEN REMOVED TRANSVAGINALLY AND THE CUFF CLOSED WITH RUNNING 2-0 VICRYL AND THE LAPRA-TY DEVICE. BILATERAL PELVIC LYMPHADENECTOMY WAS PERFORMED USING ELECTROCAUTERY. FIBRILLARE WAS PLACED IN THE RETROPERITONEAL DISSECTION SPA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S TOTAL HYSTERECTOMY FOR SYMPTOMATIC UTERINE FIBROIDS ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL OPERATIVE 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. AT THE TIME OF ROBOTIC HYSTERECTOMY THE PATIENT WAS NOTED TO HAVE EXTENSIVE LYSIS OF ADHESIONS ALONG WITH BSO. SHE WAS DISCHARGED HOME IN STABLE CONDITION THE NEXT DAY. ON (B)(6) 2010 THE PATIENT DEVELOPED SOME INCONTINENCE SHE UNDERWENT CYSTOSCOPY WHICH NOTED A FILLING DEFECT AND THEN AFTER WORSENING INCONTINENCE, A VESICOVAGINAL FISTULA WAS DIAGNOSED. ON (B)(6) 2010 UNDERWENT AN OPEN LAPAROTOMY WITH EXCISION OF THE FISTULA AND CLOSURE AND THE APPLICATION OF AN OMENTAL FLAP INTERPOSITION GRAFT.

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 PROSTATECTOMY PROCEDURE ON (B)(6) 2009 FOR ADENOCARCINOMA OF PROSTATE WITH CLINICAL STAGE T1C AND GLEASON 6. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND FOLLOW UP MEDICAL RECORDS. IN PREPARATION FOR PLANNED DA VINCI PROSTATECTOMY, A DIAGNOSTIC LAPAROSCOPY WITH POSSIBLE LYSIS OF ADHESIONS WAS PERFORMED ON (B)(6) 2009 BECAUSE THERE WERE POSSIBLE ADHESIONS IN THE UPPER ABDOMEN NOTED ABOVE WHERE ALL THE DA VINCI PORTS NEEDED TO BE PLACED. FINDINGS NOTED NO EVIDENCE OF ADHESIONS IN THE AREA NEEDED TO PLACE THE LAPAROSCOPIC PORTS WITH SUPERIORLY LOCATED ADHESIONS NOT MOBILIZED. ACCORDING TO THE DA VINCI OPERATIVE REPORT, THE CORRECT PLANE FOR BLADDER NECK TRANSECTION OF THE POSTERIOR PORTION WAS NOT ENTERED. THE BLADDER NECK WAS TRANSECTED FURTHER BACK BUT BECAUSE OF THE PREVIOUS INCISION THROUGH ALMOST A FULL THICKNESS OF THE PROSTATE DISSECTING ANY MORE POSTERIORLY WAS NOT POSSIBLE. RECTAL ATTACHMENTS WERE DIVIDED, WHICH WAS EXTREMELY DIFFICULT BECAUSE THE RECTUM WAS ADHERENT AND TENTED UP BY THE ATTACHED PROSTATE WITH A SMALL HALF TO 1 CENTIMETER RECTAL OPEN

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 A PATIENT PASSED AWAY ON (B) (6) 2009, ELEVEN DAYS AFTER UNDERGOING A UROLOGIC PROCEDURE WITH THE DA VINCI S 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 S PROSTATECTOMY PROCEDURE ON (B)(6) 2009 AND ALLEGED TO HAVE INJURIES INCLUDING POSTOPERATIVE TRAUMA AND ABDOMINAL ABSCESS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN 2008, IT WAS REPORTED THAT AFTER A SUCCESSFUL DA VINCI S MITRA VALVE REPAIR PROCEDURE, THE PT DEVELOPED COMPLICATIONS RELATED TO A HEPARIN INDUCED THROMBOCYTOPENIA. AS A RESULT, THE PT'S LEG WAS AMPUTATED. NO ADDITIONAL INFO HAS BEEN PROVIDED BY THIS SITE DESPITE ATTEMPTS.

At approximately 1:30 p.m. on August 11, 2009, Employee #1, a 42-year-old worker employed by a vehicle parts manufacturer, was loading automobile radiators onto a fixture that was bolted to a moving table. The table, which was attached to a carousel, rotated 180 degrees, and a computerized robot spot welded the front and back of the radiators. If for any reason the machine needed to be shut down (e.g., for maintenance procedures), the person performing the maintenance was required to reset a computer pendant that hung from one side of the barrier guard. This was done by pushing station button Number 1 or Number 2, depending on which station the robot was stopped. In this instance, the maintenance person did not push or set the right button, and as a result, the table moved while Employee #1 was loading a radiator. Employee #1 was temporarily trapped between the table and the barrier guard that housed a robotic welder. She received deep bruises on her chest and back, and she was hospitalized.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION CONCERNING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY WITH BILATERAL SALPINGOOOPHORECTOMY AND LYMPH NODE DISSECTION PROCEDURE ON (B)(6) 2009. THE DOCUMENTATION RECEIVED STATES THAT THE PATIENT SUSTAINED A THERMAL INJURY TO THE SMALL BOWEL CAUSING A LARGE ABSCESS TO FORM AND CAUSING A LARGE BOWEL OBSTRUCTION. ALSO STATED THAT THE JEJUNAL ENTEROTOMY WAS CONSISTENT WITH A LOW VOLTAGE INJURY TO THE SMALL BOWEL THAT OCCURRED FROM AN INSULATION DEFECT IN THE SHAFT OF THE MONOPOLAR SCISSORS USED DURING HER ROBOTIC HYSTERECTOMY. AS A RESULT OF THE BOWEL INJURY, THE PATIENT DEVELOPED A LARGE RIGHT PERIO-COLIC ABSCESS AND REQUIRED AN EXTENSIVE OPERATION WITH REMOVAL OF THE RIGHT COLON. AS A DIRECT CONSEQUENCE OF THE BOWEL INJURY, SHE HAD SEPSIS AND LATER DEVELOPED A HOSPITAL-ACQUIRED PNEUMONIA REQUIRING READMISSION AND EXTENSIVE TREATMENT. THE SURGERY PERFORMED ON (B)(6) 2009, FOUND THAT THE PATIENT HAD A NORMAL ANATOMY WITH SOME ADHESIONS FROM THE PREVIOUS CESAREAN BUT THERE WAS NO OTHER EVIDENCE OF EXTRA-UTERINE DISEASE. THE PATIENT REQUIRED EXPLORATORY LAPAROTOMY FOR POSTOP BLEEDIN

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 PROSTATECTOMY PROCEDURE ON (B)(6) 2009 FOR PROSTATE CANCER. ISI WAS PROVIDED WITH THE OPERATIVE REPORT, CONSULTATION REPORTS FROM (B)(6) 2009 AND (B)(6) 2009, AN ASSISTING VASCULAR SURGEON'S NARRATIVE, AND A SURGICAL PATHOLOGY REPORT. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION - NAMELY PROFUSE BLEEDING FROM THE ILIAC VEIN, RESULTING IN 4L OF BLOOD LOSS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THE PROCEDURE WAS UNREMARKABLE WITH THE EXCEPTION THAT THE PATIENT'S ANATOMY WAS SUCH THAT THE BOWEL WAS CONTINUALLY OBSTRUCTING THE VIEW INTO THE DEEP PELVIS AND THE PATIENT HAD A NARROW PELVIS. THE PROSTATE WAS VERY LARGE AND BROAD AT THE BLADDER BASE. DURING THE VESICOURETHRAL ANASTOMOSIS VISUALIZATION WAS VERY DIFFICULT DUE TO THE DEEP LOCATION OF THE POSTERIOR URETHRA, THE LARGE PUBIC BONE AND PUBIC TUBERCLE. THE BOWEL KEPT INTERFERING AS WELL. DURING THE ANASTOMOSIS, THE EXTERNAL ILIAC VEIN WAS INJURED. THE DA VINCI SYSTEM WAS UNDOCKED AND A MIDLINE INCISION MADE FOR THE REPAIR. VA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A ROBOTIC DAVINCI CASE THE INSTRUMENT ARM GRASPER BROKE INSIDE PT, BUT STAYING INTACT. AFTER COMPLETION OF CASE A CUTDOWN WAS PERFORMED AT THE INCISION SITE ALLOWING REMOVAL OF INSTRUMENT. OP REPORT: INSTRUMENT THROUGH 3RD DAVINCI ARM SNAPPED AT LEVEL OF PORT AND GIVEN ANGULATION; WAS DIFFICULT TO REMOVE THROUGH POA. AT THE END OF THE CASE, ARM WAS MANIPULATED AND INSTRUMENT WAS PULLED ALONG WITH ARM AFTER EXTENDING INCISION BY 2-3CM. PELVIC CAVITY WAS IRRIGATED, FRAGMENTS FROM INSTRUMENT SHEATH WERE REMOVED.

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 2 DAYS POST A DA VINCI SACROCOLPOPEXY WITH HYSTERECTOMY PROCEDURE, THE PT DEVELOPED A PERITONITIS INFECTION AND EXPIRED.

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 PLANNED DAVINCI HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, PELVIC WASHINGS, CYSTOSCOPY FOR A PREOPERATIVE DIAGNOSIS OF ENDOMETRIAL HYPERPLASIA WITH ATYPIA AND FIBROID UTERUS ON (B)(6) 2012. IN ADDITION, PATIENT HAD PRIMARY URETERAL REANASTOMOSIS TO REPAIR AN UNINTENTIONAL INTRAOPERATIVE URETERAL TRANSECTION AND BILATERAL PELVIC LYMPHNODE DISSECTION SECONDARY TO AN INTRAOPERATIVE DIAGNOSIS OF ENDOMETRIAL ADENOCARCINOMA. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY PROCEDURE AND THE TWO SUBSEQUENT PROCEDURES. NO MEDICAL HISTORY OR DISCHARGE SUMMARIES WERE PROVIDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THE SURGERY TOOK APPROXIMATELY 11 HOURS. INITIAL DIFFICULTY WAS REPORTED WITH THE FIBROUS 16 WEEK SIZE UTERUS, NECESSITATING PLACEMENT OF THE CAMERA PORT A HANDS BREADTH ABOVE THE UMBILICUS. BLEEDING WAS NOTED UPON ENTRY, AND EXTENSIVE DISSECTION REQUIRED WITH LARGE FIBROID IN THE RIGHT BROAD LIGAMENT CAUSING ANATOMICAL DISTORTION. THE HYSTERECTOMY PORTION WAS CARRIED OUT IN T

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, INCLUDING MEDICAL RECORDS, REGARDING A PATIENT THAT UNDERWENT A DA VINCI S PARAESOPHAGEAL HERNIA REPAIR WITH NISSEN FUNDOPLICATION PROCEDURE ON (B)(6) 2009. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT DIED ON (B)(6) 2013 DUE TO A RETAINED FOREIGN BODY LEFT INSIDE THE PATIENT DURING THE DA VINCI SURGICAL PROCEDURE. ON (B)(6) 2009, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR PARAESOPHAGEAL HERNIA AND WAS DISCHARGED ON (B)(6) 2009. ACCORDING TO THE DA VINCI OPERATIVE REPORT, THE PATIENT UNDERWENT A ROBOTIC-ASSISTED PARAESOPHAGEAL HERNIA REPAIR WITH NISSEN FUNDOPLICATION FOR HIS LARGE PARAESOPHAGEAL HERNIA WITH HIATAL HERNIA AND GASTROESOPHAGEAL REFLUX DISEASE. NO COMPLICATIONS WERE NOTED. ON (B)(6) 2009, THE PATIENT'S CT SCAN OF HIS ABDOMEN REVEALED A GAS FILLED STOMACH AND LOOPS OF LARGE AS WELL AS SMALL BOWEL SUGGESTING POSTOPERATIVE ILEUS AND GAS WAS SEEN IN RECTUM. THE DISCHARGE SUMMARY INDICATED THAT THE PATIENT DID WELL POSTOPERATIVELY. HE UNDERWENT A SWALLOW STUDY, WHICH WAS FOUND TO BE WITHIN NORMAL LIMITS, THE PATIENT STARTED COMPLAINING OF SOME LEFT-SIDED DISCOMFORT AND WAS NOT GIVEN ANYTHING BY MOUTH. HIS

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 RENAL PROCEDURE, THE CONSOLE SURGEON INADVERTENTLY PERFORATED ONE OF THE PATIENT'S ARTERIES RESULTING IN BLOOD LOSS BEYOND THE POINT OF REVIVAL. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI S 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 TOTAL LAPAROSCOPIC HYSTERECTOMY FOR ABNORMAL UTERINE BLEEDING AND FIBROIDS ON (B)(6) 2009. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT (B)(6) 2009. ADDITIONAL INFORMATION PROVIDED INCLUDES HISTORY AND PHYSICAL (H&P) (B)(6) 2009. OUTPATIENT FOLLOW-UP (F/U) NOTE (B)(6) 2009, EMERGENCY DEPARTMENT NOTE (B)(6) 2009 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 OPERATION WAS INITIATED WITH PLACEMENT OF A RUMI UTERINE MANIPULATOR. PNEUMOPERITONEUM WAS CREATED WITH THE VERESS NEEDLE THROUGH A PREVIOUS LAPAROSCOPIC INCISION. PORTS WERE PLACED AND THE ROBOT WAS DOCKED. USING THE BIPOLAR FORCEPS AND THE MONOPOLAR SCISSORS, THE UTERUS WAS MOBILIZED CIRCUMFERENTIALLY, INCLUDING DISSECTION OF BILATERAL LIGAMENTS; TAKE DOWN OF THE BLADDER FLAP, SKELETONIZATION AND BIPOLAR FULGURATION OF UTERINE ARTERIES. AN ADDITIONAL UTERINE BRANCH IN THE LEFT HEMIPELVIS WAS BLEEDING, WHICH WAS CONTROLLED WITH THE BIPOLAR FORCEPS. COLPOTOMY WAS CARRIED OUT

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 THREE DAYS AFTER A SUCCESSFUL DA VINCI S HYSTERECTOMY PROCEDURE, THE PT WAS RE-ADMITTED TO THE HOSP WITH A TEMPERATURE AND PERITONITIS SYMPTOMS. TWO DAYS AFTER BEING ADMITTED, A DIAGNOSTIC LAPAROSCOPY PROCEDURE WAS PERFORMED, RESULTING IN THE DISCOVERY OF EIGHT SITES ON THE PT'S SIGMOID COLON NEEDING OVER SEWING. SIX OF THE EIGHT SITES WERE IDENTIFIED AS THERMAL BURNS. NO ADDITIONAL PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

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 THAT UNDERWENT A DA VINCI UROSTOMY PROCEDURE ON (B)(6) 2009. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'PATIENT HAD A FEMORAL ARTERY NICKED, AND HE BLED TO DEATH.'

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 ROBOTIC HYSTERECTOMY WITH BSO AND LYMPHADENECTOMY. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HISTORY AND PHYSICAL, FOLLOW-UP OPERATIVE REPORTS, CONSULTATIONS, RADIOLOGY REPORTS, DISCHARGE SUMMARY, LAB REPORTS, PATHOLOGY REPORTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION NAMELY INJURY TO THE LEFT URETER WHILE TRYING TO EXCISE CANCER. IT WAS REPAIRED AT THE TIME OF THE INITIAL OPERATION. ON (B)(6) 2009 - UNDERWENT ROBOTIC TOTAL HYSTERECTOMY, BSO, PELVIC LYMPHADENECTOMY, PELVIC WASHINGS AND STAGING AND LEFT URETERO-URETERO ANASTOMOSIS WITH STENT PLACEMENT. NOTED SIGNIFICANT ADHESIONS IN SURGERY AND INJURY NOTED AT LEFT URETER DURING PROCEDURE AND REPAIRED THEN. RIGHT URETER NOT DAMAGED. RETURNED TO SURGERY ON (B)(6) 2009 FOR URINE LEAKAGE AND PINPOINT OPENING NOTED LEFT URETER AND SUTURED CLOSED. THE RIGHT URETER WAS OPENED AND A RIGHT URETERAL STENT WAS PLACED. SUBSEQUENTLY SHE DEVELOPED RE

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 DA VINCI S RADICAL NEPHRECTOMY PROCEDURE PERFORMED IN 2009, THE SURGEON ACCIDENTLY LIGATED AND CUT THE PT'S SUPERIOR MESENTERIC ARTERY. THE PROCEDURE WAS CONVERTED TO A TRADITIONAL HAND ASSISTED OPEN PROCEDURE. THE PT EXPIRED POSTOPERATIVELY IN THE SAME DAY.

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) 2015, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A BJU INTERNATIONAL JOURNAL ARTICLE TITLED, PERIOPERATIVE AND RENAL FUNCTIONAL OUTCOMES OF ELECTIVE ROBOT-ASSISTED PARTIAL NEPHRECTOMY (RAPN) FOR RENAL TUMOURS WITH HIGH SURGICAL COMPLEXITY (VOLPE ET AL., 2014). THE JOURNAL ARTICLE NOTES SEVERAL OPERATIVE COMPLICATIONS. REFER TO MFR. REPORT 2955842-2015-00706 (PATIENT IDENTIFIER (B)(6)) WHICH WAS INITIALLY SUBMITTED TO THE FDA AND BEFORE THE SITE AND SURGEON NAMES RELATED TO THE SURGICAL PROCEDURES WERE KNOWN. ON (B)(4) 2015, A CORRESPONDENCE CONTACT FOR THE JOURNAL ARTICLE PROVIDED THE SITE AND SURGEON NAMES OF THE OPERATIVE COMPLICATIONS NOTED WITHIN THE JOURNAL ARTICLE. IN THE RESULTS SECTION OF THE BJUI JOURNAL ARTICLE, THE FOLLOWING IS STATED: IN ALL, 44 RAPNS FOR RENAL TUMOURS WITH PADUA SCORES OF > 10 WERE INCLUDED IN THE ANALYSIS; 23 TUMOURS (52.3%) WERE CT1B. THE MEDIAN (INTERQUARTILE RANGE; RANGE) OPERATIVE TIME, ESTIMATED BLOOD LOSS AND WARM ISCHAEMIA (WIT) WERE 120 (94, 132; 60-230) MIN, 150 (80, 200; 25- 1200) ML AND 16 (13.8, 18; 5-35) MIN, RESPECTIVELY. TWO INTRAOPERATIVE COMPLICATIONS OCCURRED (4.5%); ONE INFERIOR VENA CAVAL INJURY AND ONE BLEED FROM THE

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) 2010, ISI WAS PRESENTED WITH LEGAL DOCUMENTATION REGARDING THE LITIGATION BETWEEN THE PLAINTIFF AND ELEVEN PARTIES INCLUDING INTUITIVE SURGICAL. THE DOCUMENTATION STATES THAT ON OR ABOUT (B)(6) 2009, THROUGH (B)(6) 2009, A PATIENT WHO UNDERWENT A GYN PROCEDURE AT THE UNIVERSITY HOSPITAL OF (B)(6) WAS SERIOUSLY AND PERMANENTLY INJURED. NO OTHER DETAILS RELATED TO THIS EVENT WERE REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI HYSTERECTOMY PROCEDURE, THE PT DEVELOPED RIGHT SHOULDER PARALYSIS. REPORTEDLY, PRIOR TO STARTING THE PLANNED SURGICAL PROCEDURE, THE SITE EXPERIENCED DIFFICULTIES PLACING THE PT IN THE TRENDELENBURG POSITION AND THE PT EXPERIENCED LABORED BREATHING.

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 IN 2009, AFTER A SUCCESSFUL DA VINCI S MITRAL VALVE REPAIR PROCEDURE, THE PATIENT EXPERIENCED DIFFICULTIES COMING OFF OF CARDIOPULMONARY BYPASS. THE PT'S HEART WAS SAID TO NOT BE CONTRACTING. TWO DAYS LATER, THE PT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR "VENTRICULAR SYSTEM." THE PT WAS REMOVED FROM LIFE SUPPORT AFTER IT WAS DEEMED THAT IT WOULD NOT BE POSSIBLE TO PERFORM "VENTRICULAR SYSTEM." THE PT EXPIRED IN THE SAME DAY.

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 DA VINCI S LUNG BIOPSY SURGICAL PROCEDURE, THE PT EXPIRED. THE SITE STATED THAT THE PLANNED DA VINCI S PROCEDURE WAS SUCCESSFULLY COMPLETED, HOWEVER, THE PT WAS IN OVERALL POOR HEALTH.

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 ROBOTIC-ASSISTED LAPAROSCOPIC RADICAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND PELVIC AND PERIAORTIC LYMPH NODE DISSECTION ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. URETEROLYSIS WAS PERFORMED; THE URETERS WERE UNROOFED USING BIPOLAR AND MONOPOLAR ENERGIES. CARE WAS TAKEN NOT TO INJURE THE URETERS. ON (B)(6) 2009, THE PATIENT PRESENTED WITH A SUSPECTED VESICOVAGINAL FISTULA. SHE UNDERWENT AN EXTENSIVE ADHESIOLYSIS, RIGHT URETEROLYSIS AND RIGHT URETERONEOCYSTOSTOMY WITH REPAIR OF VAGINAL FISTULA. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2009. THE LEGAL DOCUMENT 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.

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 THAT UNDERWENT A PANCREATIC SURGICAL PROCEDURE WITH THE DA VINCI SURGICAL SYSTEM ON (B)(6) 2009. REPORTEDLY, THE PATIENT EXPERIENCED BLEEDING AND SUBSEQUENTLY DIED. NO OTHER INFORMATION WAS PROVIDED.

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 CYSTOSCOPY WITH BILATERAL URETERAL TEMPORARY STENT PLACEMENT, DA VINCI RADICAL HYSTERECTOMY WITH RIGHT SALPINGO-OOPHORECTOMY, BILATERAL PELVIC LYMPHADENECTOMY AND LEFT OVARIAN SUSPENSION FOR AN INDICATION OF ADENOCARCINOMA OF THE CERVIX STATUS POST CONIZATION AND RIGHT ADNEXAL MASS PROCEDURE ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT AND TWO SUBSEQUENT PROCEDURE REPORTS. NO MEDICAL HISTORY WAS AVAILABLE. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. BEFORE SURGERY, THE SURGEON PERFORMED A CYSTOSCOPY AND TEMPORARY URETERAL STENT PLACEMENT. DURING SURGERY, THE SURGEON USED HOT SHEARS, FENESTRATED BIPOLAR GRASPER AND A PK DISSECTOR TO FIRST PERFORM A LYMPHADENECTOMY FROM THE COMMON ILIAC ARTERY TO THE CIRCUMFLEX VEIN AND THE OBTURATOR SPACE. THE UTERINE ARTERIES WERE ISOLATED, BIPOLAR CAUTERIZED, DIVIDED AND DISSECTED OVER THE URETERS, AND THE URETERS DISSECTED OFF OF THE MEDIAL PERITONEAL LEAVES, AND THE URETERAL TUNNELS BIPOLAR CAUTERIZED AND OPENED WITH COLD SCISSORS. THE UTEROSA

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 TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE ON (B)(6) 2009 FOR PELVIC PAIN AND ENDOMETRIOSIS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT IN ADDITION TO THE SURGICAL PATHOLOGY REPORT AND VARIOUS LAB RESULTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. UPON INITIAL EXAMINATION OF THE PELVIC CONTENTS IMMEDIATELY FOLLOWING ENDOSCOPE PLACEMENT, THE UTERUS APPEARED TO BE ENLARGED AND A DEFECT IN THE RIGHT CORNEAL REGION WAS NOTED, THROUGH WHICH THE BALLOON WAS VISIBLE. SAID DEFECT WAS CONFIRMED IN THE SURGICAL PATH REPORT. MINIMAL BLOOD LOSS OCCURRED DURING THE PROCEDURE, WHICH THE PATIENT TOLERATED WELL AND WAS TAKEN BACK TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. ON (B)(6) 2009, THE PATIENT PRESENTED WITH PELVIC PAIN AFTER INTERCOURSE. A CT SCAN FOUND A SMALL AMOUNT OF PNEUMOPERITONEUM AND NONSPECIFIC FREE FLUID IN THE PELVIS. A CONFLICTING REPORT FROM THE PHYSICIAN STATES THAT ALTHOUGH SHE TOLD THE ER STAFF THAT SHE HAD INTERCOURSE, IT WAS NOT TRUE. A VAGINAL EVALUATION WAS PERFORMED AND THE

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 OF A PATIENT WHO UNDERWENT A DA VINCI PROSTATECTOMY ON 05/01/2009 AND SUFFERED INJURIES AND DAMAGES. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

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 RADICAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL PELVIC LYMPHADENECTOMY, BILATERAL PERIAORTIC LYMPHADENECTOMY, AND OMENTECTOMY ON (B)(6) 2009 FOR CLINICAL STAGE II UTERINE SEROUS CARCINOMA. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT. PER THE OPERATIVE REPORT, THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, AND/OR AN ACCESSORY OCCURRED DURING THE DA VINCI SURGERY. NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT WAS AWAKENED, EXTUBATED, AND BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THE ESTIMATED BLOOD LOSS FROM THE SURGICAL PROCEDURE WAS 50 ML. ON (B)(6) 2009, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH SMALL BOWEL RESECTION AND ANASTOMOSIS. PER THE OPERATIVE REPORT, THE PATIENT HAD DEVELOPED RIGHT LOWER LOBE PNEUMONIA AFTER UNDERGOING THE DA VINCI SURGICAL PROCEDURE ON (B)(6) 2009 AND WAS NOTED TO BE CLINICALLY SEPTIC WITH INCREASING ABDOMINAL DISTENSION AND DISCOMFORT SUSPICIOUS FOR AN UNDERLYING ABDO

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.

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 TOTAL HYSTERECTOMY FOR MENORRHAGIA AND DYSMENORRHEA PROCEDURE ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY SURGERY AND SECONDARY REVISION SURGERY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. AFTER PORT PLACEMENT, THE ROUND LIGAMENTS, UTEROOVARIAN VASCULAR PEDICLES COAGULATED AND DIVIDED. THE BLADDER FLAP WAS CREATED, THE UTERINE ARTERIES COAGULATED AND DIVIDED AND THE COLPOTOMY PERFORMED OVER THE VCARE CUP. THE UTERUS WAS DELIVERED THROUGH THE VAGINA, SMALL BLEEDERS CONTROLLED ON THE VAGINAL CUFF WITH CAUTERY, AND THE VAGINAL CUFF CLOSED WITH POLYSORB AND A LAPRA-TY. A SHEET OF INTERCEED WAS PLACED OVER THE VAGINAL CUFF, AND THE PROCEDURE COMPLETED WITHOUT COMPLICATION. ON (B)(6) 2009, ON A POSTOPERATIVE VISIT PATIENT WAS DOING WELL WITH NO TENDERNESS, AND A WELL HEALED INCISION CITE. ON (B)(6) 2009, PATIENT PRESENTED WITH HISTORY OF PAIN WITH INTERCOURSE SINCE (B)(6) 2009. VAGINAL EXAM SHOWED ABSENT CERVIX, HEALED VAGINAL CUFF, ADNEXAL TENDERNESS. AN U/S

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 PATIENT WAS VERY SICK AND THE CASE WAS DIFFICULT. THE PATIENT WAS ALSO LARGE AND THE PROSTATE WAS LOCATED DEEP INSIDE THE PATIENT'S PELVIS. IT WAS THE SURGEON'S FIRST PROSTATECTOMY PROCEDURE USING THE DA VINCI S SURGICAL SYSTEM AND THE PROCEDURE WAS GOING SLOWLY, WITH THE SURGEON FIGHTING BOWEL THE ENTIRE CASE. NO SYSTEM MALFUNCTION OCCURRED AND ALL SURGICAL TASKS HAD BEEN PERFORMED CORRECTLY, HOWEVER, THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE DUE TO THE LENGTH OF TIME IT WAS TAKING TO COMPLETE THE PROCEDURE. TWO DAYS POST-OP, THE PATIENT EXPIRED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2009. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: DUE TO INCONTINENCE AND SURGICAL CORRECTION.

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 PROSTATECTOMY PROCEDURE (B)(6) 2009. 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 AN INJURY TO HIS OBTURATOR NERVE AND REQUIRED 4 UNITS OF BLOOD. ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT WAS HOSPITALIZED FOR 21 DAYS. REPORTEDLY, POST-OPERATIVELY THE PATIENT IS IMPOTENT AND INCONTINENT. NO OTHER INFORMATION REGARDING THE REPORTED EVENT WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATE CANCER PROCEDURE ON (B)(6) 2009. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'INCONTINENT & IMPOTENT AFTER SURGERY, HAD FOLLOW UP SURGERY 1 YEAR LATER WHERE THEY IMPLANTED AND ARTIFICIAL SPHINCTER, PAIN AFTER SURGERY'.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI S SACROCOLPOPEXY PROCEDURE, THE PT DEVELOPED DEEP VIN THROMBOSIS (DVT). NO ADDITIONAL PT HARM OR ADVERSE OUTCOME WAS REPORTED.

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 INCLUDING A MEDICAL RECORD REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2009. THE OPERATIVE REPORT FOR THE DA VINCI PROSTATECTOMY PROCEDURE WAS NOT PROVIDED; HOWEVER, AN OPERATIVE REPORT FOR THE REPAIR OF ENTEROTOMY AND SMALL BOWEL RESECTION WAS PROVIDED. ACCORDING TO THE PROVIDED OPERATIVE REPORT, THE SURGEON PERFORMING THE DA VINCI PROSTATECTOMY CONSULTED WITH ANOTHER SURGEON DURING THE PROSTATECTOMY DUE TO AN INTRA-OPERATIVE INJURY TO THE PATIENT'S SMALL BOWEL. IT WAS NOTED THAT THE PATIENT SUSTAINED THE SMALL BOWEL INJURY (ENTEROTOMY X2) DUE TO SEVERE ADHESIONS OF THE PELVIS FROM PREVIOUS TRANSABDOMINAL SURGERY. THE PATIENT RECEIVED A SMALL BOWEL RESECTION OF MID TO DISTAL ILEUM, ABOUT A 12 CM SEGMENT, WITH PRIMARY ANASTOMOSIS. THE PATIENT TOLERATED THE SMALL BOWEL REPAIR WELL AND THE REMAINDER OF THE PROSTATECTOMY WAS LEFT UNDER THE CARE OF THE INITIAL DA VINCI SURGEON. THERE WAS NO SPECIFIC ALLEGATION OF ANY MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY IN THE PROVIDED DOCUMENT. NO OTHER INFORMATION WAS PROVIDED. SINCE THE DA VINCI PROSTATECTOMY OPERATIVE REPORT

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 JOURNAL ARTICLE BY COOPER ET AL TITLED, UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS. IN THIS ARTICLE, THE AUTHORS REPORTED COMPLICATIONS REPORTED IN MAUDE DATABASE OR LEXISNEXIS, AND PACER (PUBLIC ACCESS TO COURT ELECTRONIC RECORDS) FROM JANUARY 1, 2000 TO AUGUST 1, 2012. ACCORDING TO A REPORTED INJURY IN THE ARTICLE, A FAILURE OF BAND AND CLIP DURING A PATIENT'S DA VINCI MITRAL VALVE REPAIR PROCEDURE ON (B)(6) 2009 LED TO THE PATIENT'S CONGESTIVE HEART FAILURE AND SUBSEQUENT OPEN HEART REPAIR. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT. THE HOSPITAL NAME, PATIENT INFORMATION, AND DA VINCI SYSTEM SERIAL INVOLVED WITH THIS COMPLAINT WERE NOT INCLUDED IN THE ARTICLE. ARTICLE INFORMATION: TITLE: UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS AUTHORS: MICHOL A. COOPER, ANDREW IBRAHIM, HEATHER LYU, MARTIN A. MAKARY PUBLISHED DATE: 08/27/2013 LINK: (B)(4).

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 NEPHRECTOMY PROCEDURE, WHILE THE SURGEON WAS PERFORMING THE HILAR DISSECTION TECHNIQUE, THE PATIENT BEGAN TO HEMORRHAGE. THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUE. DESPITE EFFORTS FROM THE SURGICAL STAFF, THE PATIENT HEMORRHAGING WAS NOT ABLE TO BE CONTROLLED AND THE PATIENT EXPIRED. BASED ON THE INFORMATION PROVIDED BY THE SITE, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM DID NOT MALFUNCTION AND DID NOT CONTRIBUTED TO THE PATIENT'S DEATH.

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 SACRAL COLPOPEXY FOR TOTAL VAGINAL PROLAPSE ON (B)(6) 2009. THE PROCEDURE WAS CONVERTED TO AN OPEN SACRAL COLPOPEXY. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: ADMISSION NOTES, POST-OP NOTES, DISCHARGE SUMMARY, UROLOGY CLINIC NOTES (B)(6) 2009 PRIOR TO THE PROCEDURE, THE RISKS AND BENEFITS OF SURGERY WERE DISCUSSED WITH THE PATIENT. THE PATIENT CHOSE TO UNDERGO A ROBOT-ASSISTED LAPAROSCOPIC SACRAL COLPOPEXY. THERE WAS INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION. PNEUMOPERITONEUM WAS ACHIEVED USING A DIRECT VISION TROCAR IN THE MIDLINE WITHOUT DIFFICULTY. THE CAMERA WAS THEN PLACED AND NO SIGNS OF A BOWEL INJURY WERE OBSERVED. FOUR OTHER PORTS WERE THEN PLACED AND THE TROCARS WERE PLACED UNDER DIRECT VISION AND LAPAROSCOPICALLY. THE ADHESIONS WERE TAKEN DOWN. THE ROBOT WAS THEN DOCKED. DURING TAKE DOWN OF DENSE ADHESIONS IN THE BOWEL AREA, A SMALL HOLE WAS MADE IN THE BLADDER. THE HOLE WAS SUTURE CLOSED U

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 WITH THE FOLLOWING ALLEGATION: IT WAS REPORTED THAT AFTER A DA VINCI SI NEPHRECTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2009, BLEEDING WAS NOTED FROM THE PATIENT'S AORTA. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.