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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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.