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 FOR UTERINE FIBROIDS ON (B)(6) 2009 ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES OFFICE NOTES, OPERATIVE REPORTS, CONSULTATIONS, AND RADIOLOGY FINDINGS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2009 THE PATIENT WAS ADMITTED FOR LEAKAGE OF URINE. ON (B)(6) 2009, THE PATIENT UNDERWENT A LEFT URETEROSCOPY. THE UROLOGIST NOTED CAUTERY OF TISSUE IN HIS REPORT. COULD NOT PASS A GUIDE WIRE SO NO STENT WAS PLACED. THEREFORE, A NEPHROSTOMY TUBE WAS PLACED. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2009. ON (B)(6) 2010, THE PATIENT UNDERWENT A URETERAL RE-IMPLANTATION.

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 PROSTATECTOMY ON (B)(6) 2009 FOR PROSTATE CANCER. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED FOLLOW-UP HOSPITAL MEDICAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. AN INTRAOPERATIVE COMPLICATION WAS REPORTED, SPECIFICALLY AN UNINTENDED RECTOTOMY OCCURRED WHILE DISSECTING ADHERENT PROSTATE TISSUE. IT WAS REPAIRED PRIMARILY AT THE TIME. THE PATIENT WAS OBSERVED FOR 48 HOURS IN THE HOSPITAL WITHOUT APPARENT COMPLICATION AND WAS DISCHARGED HOME IN SATISFACTORY CONDITION TO BE FOLLOWED BY HIS PHYSICIAN.

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 THE DAY FOLLOWING A SUCCESSFUL DA VINCI SI PROSTATECTOMY PROCEDURE, THE PT DEVELOPED COMPARTMENT SYNDROME IN THEIR RIGHT ARM. A SURGICAL PROCEDURE WAS PERFORMED TO RELIEVE PRESSURE TO THE PT'S AFFECTED AREA. NO ADD'L PT HARM, ADVERSE OUTCOME OR INJURY 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 REGARDING A PATIENT WHO UNDERWENT A DA VINCI ROBOTIC HYSTERECTOMY FOR FIBROIDS, ABNORMAL BLEEDING AND PELVIC PAIN 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. ON (B)(6) 2009, ROBOTIC HYSTERECTOMY WITH LYSIS OF ADHESIONS. IT WAS NOTED THE USE OF HARMONIC SCALPEL AND ROBOTIC INSTRUMENTS DURING PROCEDURE. THE PATIENT WAS DISCHARGED ON (B)(6) 2009. ON (B)(6) 2010, THE PATIENT SUBSEQUENTLY WAS DIAGNOSED WITH A VESICOVAGINAL FISTULA AND UNDERWENT A VESICOVAGINAL FISTULA REPAIR WITH LEFT URETERAL REIMPLANTATION. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. 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 NEPHRECTOMY PROCEDURE FOR RENAL CELL CARCINOMA OF THE LEFT KIDNEY ON (B)(6) 2009 AND SUBSEQUENTLY PASSED AWAY ON (B)(6) 2009. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT AS WELL AS PATHOLOGY REPORT, AUTOPSY REPORT, VARIOUS HOSPITAL RECORDS, AND DEATH CERTIFICATE. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING THE DA VINCI SURGERY IN THE PROVIDED RECORDS. THE DA VINCI OPERATIVE REPORT DATED (B)(6) 2009 INDICATED THAT THE PATIENT WAS A (B)(6) MALE WITH A 3-4 CM SOLID ENHANCING TUMOR IN THE MIDDLE OF THE KIDNEY, CONSISTENT WITH RENAL CELL CARCINOMA. THE PATIENT OPTED TO UNDERGO A NEPHRECTOMY OF THE LEFT KIDNEY AND THE SURGEON HAD DISCUSSED THE RISKS OF THE SURGERY. NO INJURIES WERE NOTED TO ADJACENT ORGANS, INCLUDING SPLEEN, BOWEL, OR GREAT VESSELS. THERE WAS LESS THAN 300 ML OF BLOOD LOSS AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION OR MALFUNCTIONS OF THE DA VINCI SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES. AN OPERATIVE R

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S LAVH-LSO FOR HISTORY OF PELVIC PAIN AND IRREGULAR VAGINAL BLEEDING ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT AND SUBSEQUENT RENAL SCAN AND ABDOMINAL ULTRASOUND REPORTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. STANDARD DISSECTION WAS PERFORMED WITH PK DISSECTOR AND CAUTERY SCISSORS, UTERUS DELIVERED TRANSVAGINALLY, VAGINAL CUFF CLOSED, AND SKIN CLOSED. ON (B)(6) 2009, PATIENT PRESENTED WITH LEFT FLANK PAIN. AN INTRAVENOUS PYELOGRAM WAS PERFORMED WHICH SHOWED DILATION OF THE LEFT URETER WITH NARROWING NEAR THE BLADDER, NO EXTRAVASATION OF CONTRAST AND DELAYED EMPTYING OF THE BLADDER DATE OF DISCHARGE IS UNKNOWN. ON (B)(6) 2009, 3 WEEKS POSTOP, PATIENT RECEIVED RENAL SCAN WITH CONTRAST FOR LEFT FLANK AND PELVIC PAIN AND H/O HYDROURETER WHICH SHOWED NORMAL RENOGRAM WITH SOME PELVIC CONTRAST ACCUMULATION. ON (B)(6) 2009, A PELVIC TRANSABDOMINAL ULTRASOUND WAS PERFORMED FOR HISTORY OF CONSTIPATION AND PE

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 ROBOTIC-ASSISTED HYSTERECTOMY ON (B)(6) 2009. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT. NO SUPPLEMENTAL INFORMATION WAS PROVIDED. ALLEGATIONS OF PATIENT COMPLICATIONS WERE AS FOLLOWS: INTESTINES WRAPPED AROUND TUBE; PATIENT DIED. 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, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY AND BILATERAL PELVIC LYMPH NODE DISSECTION PROCEDURE ON (B)(6) 2009 FOR CERVICAL CARCINOMA AND IDIOPATHIC THROMBOCYTOPENIA. 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. ADHESIONS WERE NOTED - THE OMENTUM WAS ADHERED TO THE RECTUS MUSCLES. ESTIMATED BLOOD LOSS WAS 650ML. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED ON (B)(6) 2009. ON (B)(6) 2009, THE PATIENT PRESENTED WITH LEAKING URINE. A CT SCAN SHOWED BILATERAL HYDROURETER AND URINE LEAKING IN THE PELVIC AREA, LEADING TO THE SUSPICION OF A URETERAL-VAGINAL FISTULA. PERCUTANEOUS NEPHROSTOMY WAS PERFORMED ON (B)(6) 2009. THE PATIENT WAS DISCHARGED ON (B)(6) 2009. SOMETIME BEFORE (B)(6) 2009, THE PATIENT WENT TO THE ER WHO DIAGNOSED VAGINAL CUFF DETACHMENT AND GREEN DRAINAGE. ON (B)(6) 2010, SHE WAS BROUGHT TO THE OPERATING ROOM FOR NEPHROSTOGRAMS AND A PYELOGRAM TO ASSESS THE URETERAL DEFECT FOR SURGICAL PLANNING AT

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 CONCERNING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2009. THE LEGAL COMPLAINT ALLEGED THAT THE DA VINCI SURGICAL SYSTEM MALFUNCTIONED AND THE PATIENT SUFFERED GRIEVOUS AND PERMANENT PERSONAL INJURIES, PAIN, SUFFERING AND LOSS OF ENJOYMENT OF LIFE, AGGRAVATION, EXACERBATION AND WORSENING OF PRE-EXISTING CONDITIONS, AND INCURRED PECUNIARY DAMAGES, MEDICAL, HOSPITAL, REHABILITATIVE AND OTHER EXPENSES, AND DIMINUTION OF CURRENT AND FUTURE EARNING CAPACITY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

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 SIX HOURS INTO A DA VINCI S MITRAL VALVE REPAIR PROCEDURE, THE SURGEON DECIDED TO COMPLETE THE PROCEDURE VIA A THORACOTOMY. IT WAS REPORTED THAT THE PT EXPIRED SHORTLY AFTER THE PROCEDURE. REPORTEDLY, THE PT'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 THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2009. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: DEVICE TORE A HOLE IN BLADDER, INCONTINENCE, USED CATHETER FOR 3 WEEKS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2009, AND ALLEGED TO HAVE SUSTAINED A PUNCTURED BOWEL. 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: ON SEPTEMBER 18, 2009, A REUTERS ARTICLE TITLED "MEDICAL SOCIETIES PUSH STANDARDS FOR ROBOTIC SURGERY" WAS PUBLISHED. THE ARTICLE INCLUDES QUOTES FROM DR. KEVIN ZORN AND MENTIONS HIS RECOUNT OF A CASE WHERE A PATIENT DIED POST A DA VINCI PROSTATECTOMY PROCEDURE: "HE RECOUNTED ONE CASE OF A SURGEON WHO WAS USING THE SYSTEM FOR THE FOURTH TIME. AFTER EIGHT HOURS OF SURGERY, THE PROCTOR -- AN EXPERIENCED SURGEON WHO SUPERVISES THE OPERATION -- TOLD THE SURGEON THAT PROGRESS WAS TOO SLOW. HE RECOMMENDED THE SURGEON SWITCH TO CONVENTIONAL SURGERY, WHERE AN INCISION IS MADE FROM THE NAVEL TO THE PUBIC BONE TO ACCESS THE PROSTATE. AFTER THE PROCTOR LEFT THE OPERATING ROOM, THE SURGEON CONTINUED USING THE ROBOT. THE PATIENT LATER DIED FROM COMPLICATIONS." ON SEPTEMBER 29, 2009, UPON FOLLOWING UP, IT WAS DISCOVERED THAT ANOTHER DR WAS THE PROCTOR.

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 TOWARD THE END OF A DA VINCI S SACRALCOPOPEXY PROCEDURE, THE CONSOLE SURGEON EXPERIENCED USER MESSAGE "LIGHTEN GRIP". THE CONSOLE SURGEON ATTEMPTED TO TROUBLESHOOT THE SYSTEM ERROR BY RELEASING THE GRIPS ON THE MASTER TOOL MANIPULATORS (MTM); HOWEVER, THE SYSTEM ERROR PERSISTED. THE CONSOLE SURGEON THEN PLACED THEIR HEAD BACK INTO THE HIGH RESOLUTION STEREO VIEWER (HSRV) LOCATED ON THE SURGEON'S CONSOLE AND ACCIDENTLY CLUTCHED AND CHANGED CONTROL OF THE PATIENT SIDE MANIPULATOR (PSM) FROM PSM 2 TO PSM 3. THE SURGEON WAS UNCLEAR WHY THE INSTRUMENT ON THE PSM 2 WAS NOT MOVING WHEN SHE NOTICED THAT SHE HAD ACCIDENTLY CLUTCHED AND GAINED CONTROL OF THE INSTRUMENT IN PSM 3. AT THIS POINT, THE SURGEON HAD ALREADY MOVED PSM 3 WITH INSTRUMENT DOWN CAUSING THE INSTRUMENT TO MAKE CONTACT AND INJURING THE PATIENT'S SACRAL. THE CASE WAS CONVERTED TO A TRADITIONAL OPEN PROCEDURE AND THE PATIENT'S INJURY WAS REPAIRED AND THE PROCEDURE WAS COMPLETED. AS OF 2009, THE PATIENT WAS REPORTED AS DOING WELL WITH NO FURTHER ISSUES.

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) 2009 FOR PELVIC PAIN, ENDOMETRIOSIS, AND IRREGULAR BLEEDING. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED HOSPITAL OPERATIVE, RADIOLOGY REPORTS, AND OFFICE NOTES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2009, THE PATIENT PRESENTED WITH SEVERE PAIN FOLLOWING INTERCOURSE (THE PATIENT HAD BEEN CLEARED TO RESUME THIS ACTIVITY) AND VAGINAL DISCHARGE. SHE WAS FOUND TO HAVE PARTIAL DEHISCENCE WITH EVISCERATION. ADHESIONS OF BOWEL TO CUFF NOTED. PATIENT WENT TO O.R. FOR CUFF CLOSURE. THE PATIENT REPORTED PAINFUL INTERCOURSE ON NOTES FROM (B)(6) 2010. SHE RETURNED TO THE OR FOR DIAGNOSTIC LAPAROSCOPY WITH FINDING OF VERY THIN AREA OF VAGINAL TISSUE.

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 ELEVEN DAYS POST OP A DA VINCI S MITRAL VALVE REPAIR PROCEDURE, THE PT EXPIRED. REPORTEDLY, THE PT'S DEMISE WAS UNRELATED TO THE DA VINCI S SURGICAL PROCEDURE. ON SEPTEMBER 24, 2009, AN ISI REPRESENTATIVE PROVIDED THE FOLLOWING ADD'L INFO: THE PT EXPERIENCED COMPLICATIONS RELATED TO ACUTE LUNG INJURY AND PULMONARY EMBOLISM. THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE TO A THORACOTOMY TO COMPLETE THE PLANNED SURGICAL PROCEDURE EXPEDITIOUSLY TO ALLOW FOR TAKING THE PT OFF OF BYPASS.

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: PATIENT'S STITCHES WAS CLOSED IMPROPERLY WHICH CAUSED AN INTERNAL LEAKAGE OF URINE. HE HAD EXTREME PAIN IN THE ICU. HAD A HEAT ATTACK WHICH CAUSED A BOWEL BLOCKAGE.

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 AUGUST 16TH, 2013 INTUITIVE SURGICAL, INC. RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI TOTAL HYSTERECTOMY WITH RIGHT SALPINGO-OOPHORECTOMY, LYSIS OF ADHESIONS, ABLATION OF ENDOMETRIOSIS IMPLANTS AND CYSTOSCOPY THE SURGEON'S OPERATIVE REPORT FOR THE SURGICAL PROCEDURE OF (B)(6) 2009 STATES THAT DURING THE VINCI TOTAL HYSTERECTOMY WITH RIGHT SALPINGO-OOPHORECTOMY,SIGNIFICANT SCARRING FROM THE PATIENT'S PREVIOUS SURGERY AND ENDOMETRIOSIS WERE OBSERVED. THE PATIENT'S CERVIX AND UTERUS WERE REMOVED WITHOUT COMPLICATIONS AND THE PATIENT TOLERATED THE PROCEDURE WELL. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WS DISCHARGED TO HOME THE NEXT DAY ON (B)(6) 2009. ON (B)(6) 2009, THE PATIENT PRESENTED TO HER DOCTOR'S OFFICE AND REPORTED SUDDEN ONSET OF PAIN WITH INTERCOURSE THE PREVIOUS NIGHT. EXAMINATION, PER MEDICAL CHART, SHOWED VAGINAL CUFF DEHISCENCE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SURGICAL REPAIR. THE VAGINAL

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.

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.