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 ALLOGRAFT COLPOPEXY, CYSTOCELE REPAIR, TVT MID URETHRAL TAPE WITH CYSTOSCOPY FOR TOTAL VAGINAL PROLAPSE WITH SEVERE CYSTOCELE, RECTOCELE AND ENTEROCELE AND URINARY INCONTINENCE ON (B)(6) 2012. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS. PER THE OPERATIVE REPORT, SURGICAL FINDINGS INCLUDED SIGNIFICANT ADHESIONS OF LOOPS OF SMALL BOWEL TO THE PELVIS, CUL-DE-SAC IN THE MIDLINE, AND RIGHT SIDE WALL. THE SURGEON PERFORMED THE LYSIS OF ADHESIONS ROBOTICALLY AND THE SACRAL COLPOPEXY AND TVT PORTIONS OF THE SURGERY. ANOTHER SURGEON PERFORMED THE RECTOCELE AND ENTEROCELE REPAIR PROCEDURES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING THE DA VINCI SURGERY. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012. ON (B)(6) 2013, PER A UROGYNECOLOGY OFFICE NOTE, THE FOLLOWING WAS NOTED, FEELING SORE IN ABD, REPORTED 'PURPLE LINES' NO EVIDENCE OF INFECTION, AND NO ANTIBIOTICS. IN ADDITION, THE PATIENT WAS USING IBUPROFEN FOR PAIN. THERE WAS NO OXYCODONE USE. TH

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, AN EMERGENCY CONVERSION TO OPEN SURGERY DUE TO LACK OF VISUALIZATION HAD OCCURRED. THE PATIENT EXPIRED DURING THE OPEN PROCEDURE. THERE WERE NO REPORTS OF ANY SYSTEM, INSTRUMENT(S) AND/OR ACCESSORY(IES) MALFUNCTION DURING THE COURSE OF THE PROCEDURE.

On December 15, 2012, Employee #1, a 38-year-old male with Sodecia Sterling Heights was inside a robot work cell with the interlocked gates closed. Employee #1 was struck from behind by a transfer robot, crushing his chest and neck. Employee #1 was killed in the event. Employee #1 had lock attached to his belt loop.

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 EXPIRED APPROXIMATELY FOUR WEEKS AFTER AN ESOPHAGECTOMY PROCEDURE WAS PERFORMED. THE ROBOTICALLY-ASSISTED SURGERY WAS CONVERTED TO OPEN SURGICAL TECHNIQUES, AS IT WAS STATED TO HAVE BEEN DIFFICULT FOR A NUMBER OF REASONS, ACCORDING TO THE SURGEON. THE COMPANY REPRESENTATIVE WAS INFORMED THAT THE PATIENT WAS DISCHARGED THREE WEEKS AFTER THE PROCEDURE FOR REHABILITATION. THE PATIENT THEN DIED A WEEK LATER OF WHAT THE HOSPITAL STAFF BELIEVES TO BE DUE TO A PULMONARY EMBOLISM/OTHER CARDIORESPIRATORY RELATED EVENT. NO FURTHER INFORMATION WAS 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED LEFT NEPHRECTOMY PROCEDURE AND A UMBILICAL HERNIORRHAPHY ON (B)(6) 2012 FOR A LEFT RENAL NEOPLASM AND AN UMBILICAL HERNIA. THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE PATIENT SUFFERED INJURIES AS A RESULT OF UNDERGOING THE DA VINCI SURGICAL PROCEDURE WHICH RESULTED WITH HIS DEATH ON (B)(6) 2013. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. PER THE OPERATIVE REPORT, THE FOLLOWING WAS NOTED AFTER DISSECTION WAS PERFORMED, AT THIS POINT, IT WAS DECIDED TO PROCEED WITH DIVISION OF THE RENAL ARTERY AND WITH ELEVATION OF THE SUTURE, THE ARTERY WAS CUT BETWEEN THE TWO CLIPS, BUT ON ELEVATION BLEEDING DEVELOPED POSTERIORLY, WHICH WAS CONTROLLED INITIALLY WITH THE MARYLAND BIPOLAR IN NON COAGULATION MODE AND ATTEMPTS WERE MADE TO PLACE A SINGLE CLIP IN THE MAIN RENAL ARTERY HOWEVER, THIS WOULD NOT HOLD AND BLEEDING IMMEDIATELY ENSUED. THE PATIENT WAS URGENTLY CONVERTED TO AN OPEN THROUGH A LEFT PARAMEDIAN INCISION AND THE AORTA WAS CONTROLLED WITH DIGITAL PRESSURE. APPROXIMATELY 900 CC OF BLOOD WAS LOST DURING THIS RAPID CONVERSION. IT WAS NOTED THAT THE LEFT 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT INDICATE THAT THE PATIENT UNDERGOING THE DA VINCI HYSTERECTOMY PROCEDURE WAS A MALE PATIENT. THE LEGAL DOCUMENT ALLEGES THAT AS A RESULT OF THE DA VINCI PROCEDURE THE PATIENT SUBSEQUENTLY DIED. THE DATE OF DEATH WAS NOT PROVIDED TO INTUITIVE SURGICAL INC. (ISI). NO FURTHER CLINICAL INFORMATION WAS PROVIDED. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI OPERATIVE LAPAROSCOPY, TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL URETEROLYSIS, ENTEROLYSIS, BILATERAL PELVIC LYMPHADENECTOMIES AND CYSTOSCOPY FOR PELVIC MASS (RULE OUT OVARIAN CARCINOMA), PROBABLE ENDOMETRIAL CARCINOMA ON (B)(6) 2012. INTUITIVE SURGICAL, INC (ISI) WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: DEATH CERTIFICATE OF THE COUNTY OF SANTA CLARA OF (B)(6) 2012, DEATH SUMMARY OF (B)(6) 2012, LETTER TO CLEAR PATIENT FOR SURGERY OF (B)(6) 2012, AND A REPORT OF TRANSTHORACIC ECHOCARDIOGRAM OF (B)(6) 2012. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. BASED ON THE OPERATIVE REPORT, INTRA-OPERATIVELY, AN EXTENSIVE RETROPERITONEAL FIBROSIS WAS FOUND. ALSO, THERE WAS EXTENSIVE TRUNCAL OBESITY. INTRA-ABDOMINALLY, THERE WERE EXTENSIVE AMOUNT OF PELVIC ADHESIONS, PARTICULARLY ALONG THE LEFT PELVIC SIDEWALL. THE OPERATIVE REPORT STATES THAT THIS PROCEDURE REQUIRED SUBSTANTIALLY INCRE

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY FOR ENDOMETRIAL CANCER, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL PELVIC LYMPHADENECTOMY, RIGHT PERIO-AORTIC LYMPH NODE DISSECTION, PARTIAL OMENTECTOMY, AND CYSTOSCOPY ON (B)(6) 2012. ACCORDING TO THE LEGAL DOCUMENT, THE PATIENT WAS DISCHARGED FROM THE OPERATING ROOM AFTER THE SURGICAL PROCEDURES WERE COMPLETED AND THE PATIENT WAS ADMITTED FOR POST-OPERATIVE CARE. ON POST-OP DAY 1 ((B)(6) 2012), THE PATIENT EXPERIENCED SEVERE ABDOMINAL PAIN DURING HER FIRST ATTEMPT TO USE THE BATHROOM AND WAS GIVEN TORADOL FOR PAIN. LATER THAT SAME DAY, THE PATIENT WAS GIVEN DILAUDID 1 MG IV FOR CONTINUED SEVERE ABDOMINAL PAIN. APPARENTLY, THE PATIENT'S ABDOMINAL PAIN PERSISTED WITH INCREASING INTENSITY AND SHE WAS NO LONGER ABLE TO AMBULATE. BY 6:12 PM THAT SAME DAY, THE PATIENT WAS STARTED ON IV PATIENT-CONTROLLED ANALGESIA (PCA) FOR SEVERE ABDOMINAL PAIN. THROUGHOUT THE NIGHT, THE PATIENT REPORTEDLY EXPERIENCED INCREASING ABDOMINAL PAIN AND RESPIRATORY DISTRESS. ON POST-OP DAY 2 ((B)(6) 2012) AT 6:45 AM, THE PATIENT UNDERWENT A CT SCAN OF HER CHEST, ABDOMEN, AND PELVIS W

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-ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, LYSIS OF ADHESIONS AND BILATERAL PELVIC LYMPH NODE DISSECTION ON (B)(6) 2012 FOR ENDOMETRIAL CARCINOMA AND SIGNIFICANT PELVIC ADHESIVE DISEASE. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. PER THE DA VINCI OPERATIVE REPORT, NO COMPLICATIONS WERE NOTED AND THE ESTIMATED BLOOD LOSS WAS 50 ML. POST-OPERATIVELY, THE PATIENT EXPERIENCED ANEMIA AND ACUTE RENAL FAILURE. SHE RECEIVED 3 UNITS OF PACKED RED BLOOD CELLS, AND HER ANEMIA SUBSEQUENTLY RESOLVED AND HER CREATININE IMPROVED. THERE WAS ALSO CONCERN FOR CONGESTIVE HEART FAILURE, ALTHOUGH AN ECHOCARDIOGRAM REVEALED A NORMAL EJECTION FRACTION. THE PATIENT WAS CONTINUED ON MODERATE FLUIDS AND WAS GIVEN A DOSE OF LASIX; AFTER THIS, HER SYMPTOMS IMPROVED AND HER EDEMA BEGAN TO IMPROVE. DUE TO LOW PLATELETS OF 59,000, THE PATIENT WAS GIVEN ONE DOSE OF DESMOPRESSIN ACETATE (DDAVP). THE PATIENT WAS AL

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 ADRENALECTOMY PROCEDURE FOR A VERY LARGE ADRENAL MASS ON (B)(6) 2012. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP HOSPITAL RECORDS AND DEATH SUMMARY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2012 PATIENT UNDERWENT ROBOTIC ADRENALECTOMY. THE ADRENAL GLAND WAS NEARLY DETACHED WHEN AN EXCESSIVE AMOUNT OF BLEEDING WAS NOTED TO BE COMING FROM THE INFERIOR VENA CAVA. THEORETICALLY THE ADRENAL VEIN RUPTURED OR WAS TORN FROM THE IVC. EXCESSIVE BLEEDING ENSUED BUT WAS ULTIMATELY CONTROLLED BY PLACING A HAND PORT. A VASCULAR SURGEON WAS SUMMONED AND ARRIVED. AN IVC REPAIR WAS UNDERTAKEN AND ACCOMPLISHED VIA LAPAROTOMY. INTRAOPERATIVELY THE PATIENT BECAME HYPOTENSIVE AND SUFFERED CONSEQUENCES DESPITE RECEIVING A BLOOD TRANSFUSION. A MYOCARDIAL INFARCTION OCCURRED FOLLOWED BY A SEVERE ARRHYTHMIA. ON (B)(6) 2012, A CARDIAC CATHETERIZATION WAS PERFORMED WHICH SHOWED COMPLETE OCCLU

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 2 DAYS POST A SUCCESSFUL DA VINCI SI MYOMECTOMY PROCEDURE, THE PATIENT EXPIRED. THE INTUITIVE SURGICAL CLINICAL SALES REPRESENTATIVE (CSR) THAT REPORTED THIS INCIDENT INDICATED THAT ON (B)(6) 2012, THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE REPORTED TO HIM THAT A TENACULUM FORCEPS INSTRUMENT BEING USED DURING THE SURGICAL PROCEDURE WAS NOT MOVING AS IT SHOULD. THE CSR INDICATED THAT HE INSTRUCTED THE SURGEON TO HAVE THE INSTRUMENT REMOVED, CLEANED AND RE-INSTALLED. THE CSR INDICATED THAT THE SITE PROCEEDED USING THE INSTRUMENT AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED TO HAVE OCCURRED AT THE TIME OF THE SURGICAL PROCEDURE. ON (B)(6) 2012, THE INTUITIVE SURGICAL CSR WAS NOTIFIED BY THE SURGEON THAT THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2012 DUE TO A PERFORATED BOWEL AND THE PATIENT EXPIRED ON (B)(6) 2012. THE CSR INDICATED THAT THE SURGEON INDICATED THE SURGICAL PROCEDURE WENT FINE. THE SURGEON INDICATED TO THE CSR THAT A VIDEO RECORDING OF THE SURGICAL PROCEDURE IS NOT AVAILABLE AND THAT THE CAUSE OF THE PATIENT'S INJURY IS UNKNOWN. LATE SUBMISSION OF THE MEDWATCH REPORT IS DUE TO

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 HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND BILATERAL PERIAORTIC AND PELVIC LYMPH NODE DISSECTION PROCEDURE FOR CERVICAL CANCER ON (B)(6) 2012. REPORTEDLY, THE PATIENT SUSTAINED A URETERAL INJURY REQUIRING THE PATIENT TO UNDERGO A STENT IMPLANTATION AND REMOVAL, A CYSTOGRAM AND A CYSTOSCOPY. ON (B)(6) 2013, THE PATIENT EXPIRED DUE TO METASTATIC CERVICAL CANCER. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT AND FOLLOW-UP HOSPITAL MEDICAL RECORDS. A CAREFUL REVIEW OF THE MEDICAL DOCUMENTATION WAS CONDUCTED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES DURING THE DA VINCI SURGICAL PROCEDURE AND THERE WAS NO INDICATION THE PATIENT EXPERIENCED ANY INTRAOPERATIVE COMPLICATIONS. ACCORDING TO THE INFORMATION IN THE PATIENT'S MEDICAL RECORDS, ON (B)(6) 2013, THE PATIENT WAS ADMITTED INTO THE HOSPITAL DUE TO FALLING AT HOME. DURING THE PATIENT'S HOSPITALIZATION THE PATIENT WAS FOUND TO BE ANEMIC, DEHYDRATED AND HAD WORSENING SYMPTOMS OF PARKINSON'S DISEASE. THE PATIENT WAS DIAGNOSED WITH ACUTE REN

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 TWO DAYS AFTER A DA VINCI SI TONGUE BASE RESECTION (TORS) PROCEDURE WAS SUCCESSFULLY PERFORMED, THE PATIENT EXPIRED DUE TO UNCONTROLLABLE POST OPERATIVE BLEEDING.

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 AFTER UNDERGOING A DA VINCI VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6), THE PATIENT EXPIRED. THE DATE OF THE PATIENT'S DEATH AND CAUSE OF DEATH ARE UNKNOWN.

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 ROBOT ASSISTED MITRAL VALVE REPAIR AND CRYO MAZE PROCEDURE ON (B)(6) 2012 FOR MODERATE TO SEVERE MITRAL REGURGITATION AND ATRIAL FIBRILLATION. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT, PREOPERATIVE HISTORY AND PHYSICAL, AND DISCHARGE SUMMARY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING THE DA VINCI SURGERY. THERE WERE NO INTRAOPERATIVE COMPLICATIONS DURING THE PERFORMANCE OF THE MITRAL VALVE SURGERY. THE ROBOTIC ASSISTED MITRAL VALVE REPAIR WAS PERFORMED FIRST AFTER PLACING THE PERSON ON CARDIOPULMONARY BYPASS UTILIZING THE RIGHT FEMORAL ARTERY AND IVC CANNULA. SYSTEMIC COOLING WAS DONE PRIOR TO AORTIC CROSS CLAMP AND THE HEART WAS NEXT PERFUSED WITH CARDIOPLEGIA. SYSTEMIC HYPERTHERMIA TO 32 DEGREES C WAS UTILIZED AS WAS REPEAT INFUSIONS OF CARDIOPLEGIA. THE ROBOTIC APPROACH WAS DONE THOUGH THE INTER-ATRIAL EXPOSURE. THE VALVE WAS REPAIRED USING AN ANNULOPLASTY RING. THE ATRIA WAS THEN CLOSED. AFTER COMPLETION OF THE MITRAL VALVE REPAIR WITH THE ROBOT THE CYROMAZE PROCEDURE W

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A SUCCESSFUL DA VINCI SI MITRAL VALVE REPAIR PROCEDURE, THE PATIENT WAS UNABLE TO STABILIZE AND THE SURGEON DECIDED TO COMPLETE THE PROCEDURE VIA A THORACOTOMY. IT WAS REPORTED THAT THE PATIENT EXPIRED SHORTLY AFTER THE PROCEDURE. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SI SURGICAL SYSTEM.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A SUCCESSFUL DA VINCI SI HYSTERECTOMY PROCEDURE THE PATIENT EXPIRED. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SI SURGICAL SYSTEM.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI PARTIAL NEPHRECTOMY PROCEDURE DURING TUMOR REMOVAL THE PATIENT STARTED BLEEDING. IT WAS NOTICED THAT THE PATIENT'S VENA CAVA WAS RUPTURED. THE PATIENT WAS SUPPLIED BLOOD, HOWEVER THE PATIENT EXPIRED. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SI SURGICAL SYSTEM.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI RADICAL RETROPUBIC PROSTATECTOMY FOR LOCALIZED PROSTATE CANCER ON (B)(6) 2012. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. PER THE OPERATIVE REPORT, DURING THE DISSECTION OF THE PROSTATE, COMING UP ON THE LEFT SIDE, AT THE APEX, WENT A LITTLE DEEP, AND THERE WAS A SMALL 1 CM HOLE IN THE RECTUM... THIS WAS SUBSEQUENTLY CLOSED, ...AND WE GOT AN EXCELLENT CLOSURE OF THAT TINY LITTLE HOLE. THE SURGERY CONTINUED TO COMPLETION, AND A FOLEY CATHETER WAS PLACED. THE SURGEON NOTED, THERE WAS NO BLOOD ACCUMULATION AND I WAS CONCERNED ABOUT A JACKSON-PRATT DRAINAGE WITH THE RECTUM, THAT MIGHT WORK ITS WAY THROUGH IT, SO I DECIDED NOT TO LEAVE A JACKSON-PRATT DRAIN. THE SURGEON ALSO NOTED THAT PRIOR TO EVACUATION OF CO2 FROM THE ABDOMEN, THERE WAS A LITTLE INFLATION OF SOME AIR IN THE SCROTUM, THAT WAS DECOMPRESSED. NO FURTHER INTRAOPERATIVE COMPLICATIONS WERE NOTED AND THE ESTIMATED BLOOD LOSS WAS 500 ML. AT THE CONCLUSION OF THE SURGICAL PROC

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE THE SURGEON EXPERIENCED VISUALIZATION PROBLEMS DUE TO THE PATIENT'S ANATOMY ON (B)(6) 2008. AFTER SEVERAL HOURS THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PROSTATECTOMY. DURING THE OPEN PORTION OF THE PROSTATECTOMY PROCEDURE A RECTAL LACERATION WAS DISCOVERED, AND A SPECIALIST WAS CALLED IN TO PERFORM AN EMERGENCY REPAIR. IT WAS REPORTED THAT BLOOD LOSS DURING THE PROCEDURE WAS ESTIMATED AT 3500CC, FLUID REPLACEMENT WAS 7500ML CRYSTALLOID, FOUR UNITS OF PACKED RED CELLS, AND ONE UNIT OF AUTOGOUS BLOOD. IT WAS REPORTED THAT ON (B)(6) 2008 THE PATIENT WAS TRANSPORTED BY AMBULANCE TO AN INTENSIVE CARE UNIT. ON (B)(6) 2008 THE PATIENT WAS TRANSFERRED TO A REHABILITATION CENTER. ON (B)(6) 2012 ISI BECAME AWARE THAT THE PATIENT EXPIRED FROM CARDIAC ARREST ON (B)(6) 2012.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT APPROXIMATELY 2 WEEKS POST A DA VINCI SI HYSTERECTOMY PROCEDURE, THE PATIENT DEVELOPED A PULMONARY EMBOLISM AND EXPIRED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI PROSTATECTOMY FOR PROSTATE CANCER ON (B)(6) 2012. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT'S URETHRA WAS CUT, ADDITIONAL SURGERY WAS REQUIRED, AND THE PATIENT PASSED AWAY FROM SEPTIC SHOCK ON (B)(6) 2012. INTUITIVE SURGICAL, INC. (ISI) WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY PATIENT MEDICAL RECORDS. BASED ON THE LEGAL DOCUMENT PROVIDED, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI-ASSISTED MITRAL VALVE REPAIR PROCEDURE ON (B)(6) 2012 FOR A HISTORY OF ATRIAL FIBRILLATION AND MITRAL STENOSIS. ISI WAS NOT PROVIDED WITH THE DA VINCI OPERATIVE REPORT. BASED ON THE LEGAL DOCUMENTS PROVIDED BY THE PLAINTIFF'S ATTORNEY, THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY OCCURRED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. THE PLAINTIFF'S ATTORNEY CLAIMS THAT DURING THE SURGICAL PROCEDURE, THE SURGEON ALLEGEDLY CAUSED A TEAR TO THE DOME OF THE LEFT ATRIUM, CAUSING SEVERE PERMANENT LUNG DAMAGE AND DEATH ON (B)(6) 2012. ACCORDING TO THE LEGAL DOCUMENTS PROVIDED, THE PATIENT PASSED AWAY FROM ADULT RESPIRATORY DISTRESS SYNDROME DUE TO MITRAL STENOSIS. THE PLAINTIFF'S ATTORNEY ALSO ALLEGES THAT THE SURGEON FAILED TO CONVERT TO OPEN SURGERY AFTER HE CAUSED THE TEAR TO THE ATRIUM. NO FURTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A TUMOR REMOVAL IN THE PANCREAS PROCEDURE WITH THE DA VINCI SURGICAL SYSTEM ON (B)(6) 2012. REPORTEDLY, THE PATIENT SUSTAINED A BURN INJURY TO HER DUODENAL VEIN. THE PATIENT WAS AIRLIFTED TO ANOTHER HOSPITAL AND SUBSEQUENTLY DIED. NO OTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL RECEIVED A LEGAL COMPLAINT ALLEGING THAT A PATIENT WHO UNDERWENT A DA VINCI SI SURGICAL PROCEDURE ON (B)(6) 2012, EXPIRED ON (B)(6) 2012. THE LEGAL COMPLAINT ALLEGES THAT FROM (B)(6) 2012, THE PATIENT REQUIRED CARE AND TREATMENT.

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 BILATERAL SALPINGO OOPHORECTOMY PROCEDURE ON (B)(6) 2012 FOR PELVIC MASS AND SUBSEQUENTLY PASSED AWAY ON (B)(6) 2012 DUE TO CARDIOPULMONARY COLLAPSE. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT ALONG WITH FOLLOW-UP HOSPITAL REPORTS. ACCORDING TO THE DA VINCI SURGERY OPERATIVE REPORT DATED (B)(6) 2012, THE PATIENT HAS A HISTORY OF A LIVER TRANSPLANT AND CROHN'S DISEASE. DURING SURVEILLANCE OF HER LIVER TRANSPLANT IN (B)(6) 2011, AN ABDOMINAL MRI REVEALED SHE HAD A LOBULATED, SEPTATED CYSTIC MASS IN THE LEFT ADNEXAL REGION THAT WAS NOT SEEN IN PRIOR EXAMS. AN ULTRASOUND ALSO REVEALED THAT THE PATIENT WAS FOUND TO HAVE A COMPLEX ADNEXAL MASS MEASURING 4.5 CM X 3.3 CM WITH CYSTIC AND SOLID COMPONENTS. A DECISION WAS MADE TO PROCEED WITH THE BILATERAL SALPINGO-OOPHORECTOMY. RISKS, BENEFITS AND ALTERNATIVES WERE DISCUSSED WITH THE PATIENT. THE PATIENT ALSO HAD A SIGNIFICANT PULMONARY HISTORY (COPD) AND A BRONCHOSCOPY WAS PERFORMED AT THE BEGINNING OF THE DA VINCI SURGICAL PROCEDURE. AFTER THE DA VINCI ROBOTIC CAMERA WAS INSERTED, DIFFUSE ADHESIONS

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 SUSTAINED A VESSEL INJURY WHILE UNDERGOING A PLANNED DA VINCI-ASSISTED HYSTERECTOMY ON (B)(6) 2012 FOR A SYMPTOMATIC, 15 TO 16-WEEK SIZE FIBROID UTERUS. THE PATIENT SUBSEQUENTLY PASSED AWAY THAT SAME DAY. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. PER THE DA VINCI OPERATIVE REPORT, AT THE BEGINNING OF THE SURGICAL PROCEDURE THE LAPAROSCOPE WAS INTRODUCED AND THE ABDOMEN WAS INSUFFLATED. AT THAT POINT, NO EVIDENCE OF SIGNIFICANT BLEEDING WAS OBSERVED. FOUR TROCARS WERE THEN PLACED WITHOUT DIFFICULTY AND UNDER DIRECT VISUALIZATION WITH THE LAPAROSCOPE. HOWEVER, 1-2 MINUTES AFTER THE LAST TROCAR WAS INSERTED, ANESTHESIA INFORMED THE SURGEON THAT THE PATIENT'S BLOOD PRESSURE HAD COMPLETELY BOTTOMED OUT. THE SURGEON BRIEFLY INSPECTED THE PELVIS AND ABDOMINAL CAVITY AND DID NOT SEE ANY EVIDENCE OF ACTIVE BLEEDING. THE SURGEON SUSPECTED A VASCULAR INJURY AND MADE THE DECISION TO CONVERT TO OPEN SURGERY. THE SURGEON IDENTIFIED

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 EXPIRED AFTER UNDERGOING A DA VINCI SI PROSTATECTOMY PROCEDURE.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: COMPLICATIONS WERE DESCRIBED IN A ORAL PRESENTATION (B)(6). ACCURAY PREVIOUSLY CONTACTED THE PHYSICIAN AND CONFIRMED THAT THE REPORTED COMPLICATIONS WERE NOT DUE TO A MALFUNCTION OF THE CYBERKNIFE SYS. THE PTS HAD RECEIVED PRIOR RADIOTHERAPY AND WERE UNDERGOING RE-IRRADIATION BY THE CYBERKNIFE SYS IN AN ATTEMPT TO CONTROL RECURRENT DISEASE. DUE TO THE NATURE AND EXTENT OF DISEASE, CYBERKNIFE TREATMENT WAS THE ONLY TREATMENT OPTION FOR THE PTS IN THE STUDY. THE TOXICITIES EXPERIENCED BY THE PTS ARE KNOWN TO BE ASSOCIATED WITH RE-IRRADIATION.

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 THE PATIENT UNDERWENT A HEMICOLECTOMY PROCEDURE ON (B)(6) 2012 IN WHICH TRADITIONAL LAPAROSCOPIC TECHNIQUES AND THE DA VINCI SI SYSTEM WERE USED. AN UNRECOGNIZED BOWEL PERFORATION OCCURRED WHILE PERFORMING TRADITIONAL LAPAROSCOPIC TECHNIQUES DURING ADHESIOLYSIS. THE PATIENT EXPIRED ON (B)(6) 2012.

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 ROBOTICALLY-ASSISTED MINI TVR (TRICUSPID VALVE REPAIR) PROCEDURE VIA RIGHT THORACOTOMY ON (B)(6) 2012. THE LEGAL DOCUMENT PROVIDED CLAIMS THAT AS A RESULT OF THE SURGICAL PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS AND DAMAGES INCLUDING BUT NOT LIMITED TO RESPIRATORY FAILURE AND HD INSTABILITY, PORTAL VEIN THROMBOSIS WITH ELEVATED BILIRUBIN, AND EVENTUALLY, DEATH. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR THE PATIENT'S MEDICAL RECORDS. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING SURGERY.

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 AFTER A DA VINCI PARTIAL NEPHRECTOMY WAS COMPLETED, IT WAS DETERMINED THAT THE PATIENT REQUIRED ANOTHER PROCEDURE. THE PATIENT THEN UNDERWENT AN OPEN PROCEDURE, FOR A TOTAL NEPHRECTOMY. AFTERWARDS, THE PATIENT WAS TRANSFERRED TO (B)(6), WHERE THE PATIENT EXPIRED ON AN UNKNOWN DATE. THE DELAY IN REPORTING IS DUE TO AN ADMINISTRATIVE OVERSIGHT WHERE THE AWARE DATE WAS INADVERTENTLY NOT UPDATED BY A CUSTOMER SERVICE REPRESENTATIVE.

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 AFTER UNDERGOING A DA VINCI SI CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2012, THE PATIENT LATER EXPIRED ON (B)(6) 2012. DURING THE SURGICAL PROCEDURE, THE SURGEON DECIDED TO REMOVE THE PATIENT'S GALL BLADDER USING TRADITIONAL LAPAROSCOPIC TECHNIQUES AND WITHOUT USING A BAG. AN ISI REPRESENTATIVE IN ATTENDANCE DURING THE SURGICAL PROCEDURE INDICATED THAT NO SYSTEM MALFUNCTIONS OCCURRED DURING THE CASE AND THE PLANNED PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY SURGICAL PROCEDURE ON (B)(6) 2012. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR MEDICAL RECORDS. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. PER THE LEGAL DOCUMENT, THE PATIENT SUFFERED A PERFORATED BOWEL AND DIED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THIS EVENT.

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 MEDIATION EFFORT, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO SUSTAINED AN INJURY TO HER MESENTERIC VEIN PRIOR TO THE START OF A PLANNED DA VINCI SI BILATERAL PELVIC AND PARA-AORTIC LYMPHADENECTOMY PROCEDURE ON (B)(6), 2012. ACCORDING TO THE PROCEDURE NOTE, THE INJURY OCCURRED DURING TROCAR PLACEMENT FOR AN EXPLORATORY LAPAROTOMY FOR STAGING OF UTERINE CANCER. THE PATIENT HAD NOT YET BEEN DOCKED TO THE DA VINCI SI SURGICAL SYSTEM AT THE TIME THE INJURY OCCURRED. THE PATIENT'S MEDICAL HISTORY INCLUDED RECENT TOTAL VAGINAL HYSTERECTOMY ((B)(6) 2012) THAT REVEALED STAGE IB ENDOMETRIAL CARCINOMA THAT REQUIRED SURGICAL STAGING. PRIOR TO THE START OF THE PLANNED SURGICAL PROCEDURE, THE PATIENT WAS INFORMED OF THE RISKS, BENEFITS, PERIOPERATIVE COMPLICATIONS, AND CONVALESCENCE RELATED TO THE PROCEDURE AND SURGICAL CONSENT WAS SIGNED. ACCORDING TO THE OPERATIVE REPORT, AT THE BEGINNING OF THE PLANNED SURGICAL PROCEDURE, A 12 MM TROCAR WAS PLACED SUPRAUMBILICALLY. THE PATIENT WAS NOTED TO HAVE MASSIVE OMENTAL ADHESIONS TO THE PELVIS, SMALL BOWEL, DESCENDING COLON, AND ANTERIOR ABDOMINAL WALL. UPON DIRECT INSERTION

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 POLYP REMOVAL PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'SURGERY TOOK 5 1/2 HOURS INSTEAD OF 2 DUE TO SCAR TISSUE , HAD TO INTUBATE HIM BECAUSE HE COULD NOT BREATHE, A TEAR IN HIS INTESTINE, DEVELOPED A RASH WHOLE BACK TURNED BACK DOCTORS DID NOTHING, PASSED AWAY FOLLOWING MORNING AUTOPSY SHOWS AN INFECTION.'

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 1 DAY AFTER A DA VINCI S HYSTERECTOMY PROCEDURE WAS SUCCESSFULLY PERFORMED, 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: TEXT FROM PATIENT IDENTIFIER = (B)(6), MFR REPORT 2955842-2013-04055: 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) 2012 FOR HIGH RISK ADENOCARCINOMA OF THE PROSTATE AND SUBSEQUENTLY EXPIRED ON (B)(6) 2012. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT AND ADDITIONAL INFORMATION INCLUDING READMISSION NOTES AND LAB WORK. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION; HOWEVER, THE SURGEON EXPERIENCED DIFFICULTY CONTROLLING BLEEDING FROM THE DORSAL VENOUS COMPLEX SO THE DA VINCI SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN LAPAROTOMY. TRANSFUSIONS WERE REQUIRED WITH RBC AND PLATELETS. THE PATIENT'S HEMATOCRIT WAS LOW (27%). SUPERFICIAL VENOUS THROMBOSIS WAS NOTED ON THE RIGHT LESSER SAPHENOUS VEIN. THE PATIENT WAS DISCHARGED ON (B)(6) 2012. THE PATIENT RETURNED TO THE EMERGENCY ROOM AND REPORTED URINE LEAKING AFTER MANIPULATION OF THE CATHETER AT HOME. ON (B)(6) 2012, A DRAINAGE CATHETER WAS PLACED IN ABDOMEN. ON (B)(6) 2012, THE PATIENT DEVELOPED

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 PROSTATECTOMY PROCEDURE ON (B)(6) 2012 FOR HIGH RISK ADENOCARCINOMA OF THE PROSTATE AND SUBSEQUENTLY EXPIRED ON (B)(6) 2012. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT AND ADDITIONAL INFORMATION INCLUDING READMISSION NOTES AND LAB WORK. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION; HOWEVER, THE SURGEON EXPERIENCED DIFFICULTY CONTROLLING BLEEDING FROM THE DORSAL VENOUS COMPLEX SO THE DA VINCI SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN LAPAROTOMY. TRANSFUSIONS WERE REQUIRED WITH RBC AND PLATELETS. THE PATIENT'S HEMATOCRIT WAS LOW (27%). SUPERFICIAL VENOUS THROMBOSIS WAS NOTED ON THE RIGHT LESSER SAPHENOUS VEIN. THE PATIENT WAS DISCHARGED ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT RETURNED TO THE EMERGENCY ROOM AND REPORTED URINE LEAKING AFTER MANIPULATION OF THE CATHETER AT HOME. ON (B)(6) 2012, A DRAINAGE CATHETER WAS PLACED IN ABDOMEN. ON (B)(6) 2012, THE PATIENT DEVELOPED PULSELESS ELECTRICAL ACTIVITY AND COULD NOT BE RESUSC

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE, DURING PLACEMENT OF THE UTERINE MANIPULATOR, THE PATIENT'S BOWEL WAS RUPTURED. THE SURGEON REPAIRED THE PATIENT'S BOWEL, WHICH TOOK APPROXIMATELY 3 HOURS TO REPAIR. TWO DAYS POST OP THE PATIENT EXPERIENCED CARDIOVASCULAR COMPLICATIONS AND COMPLICATIONS AND EXPIRED. THE SURGEON IS ATTRIBUTING THE PATIENT'S DEMISE TO A T-BERG. 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: IT WAS REPORTED THAT APPROXIMATELY ONE YEAR AGO, A PATIENT EXPIRED AFTER UNDERGOING A DA VINCI SI GYNECOLOGICAL PROCEDURE.

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, MINOR BLEEDING OCCURRED. THE BLEEDING WAS REGARDED AS NORMAL BLEEDING FROM MINOR VESSELS. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WENT INTO RECOVERY. THE PATIENT SEEMED FINE DURING RECOVERY; HOWEVER, AT AN UNKNOWN TIME AFTER THE SURGERY, THE PATIENT EXPIRED. NO FURTHER 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 45 MINUTES INTO A DA VINCI SI PROCEDURE WHEN THE ASSISTANT AT THE PATIENT SIDE CART (PSC) PERFORMED A TOOL CHANGE TO SWITCH THE INSTRUMENTS IN THE PATIENT SIDE MANIPULATOR (PSM) ARMS, THE PATIENT'S AORTA WAS PUNCTURED. THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED SURGICAL PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION RIGHT AFTER THE OPEN SURGICAL PROCEDURE, HOWEVER, THE PATIENT EXPIRED THE FOLLOWING DAY. THE SITE HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN FORTHCOMING.

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 S TOTAL HYSTERECTOMY WITH LYMPHADENECTOMY FOR ADENOCARCINOMA OF THE ENDOMETRIUM (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT . ADDITIONAL INFORMATION PROVIDED INCLUDES OFFICE AND HOSPITAL NOTES REGARDING FOLLOW UP CARE. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY]. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2012 THE PATIENT UNDERWENT RADICAL HYSTERECTOMY WITH BSO, RIGHT PELVIC LYMPH NODE BIOPSY AND APPENDECTOMY ON. DISCHARGED ON (B)(6) 2012. RE-ADMISSION ON (B)(6) 2012 FOR EXPLORATORY LAPAROTOMY FOR PELVIC ABSCESS WITH SEPTIC SHOCK. LARGE 8-10 CM POSTERIOR ABSCESS NOTED. NO INTESTINAL PERFORATION OR OTHER INJURY WAS NOTED. UNFORTUNATELY, FOLLOWING SURGERY, SHE EXPIRED DUE TO SEPTIC CONDITION.

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 HIATAL HERNIA REPAIR PROCEDURE ON (B)(6) 2012. ACCORDING TO THE LEGAL DOCUMENT PROVIDED, THE SURGEON SUSPECTED DURING THE DA VINCI SURGERY THAT HE HAD INJURED THE PATIENT'S BOWEL AND DECIDED TO CONVERT TO AN OPEN PROCEDURE. DURING THE OPEN PROCEDURE, THE SURGEON REPORTEDLY DISCOVERED A BOWEL PERFORATION (HOLE IN HER BOWELS). HE ALSO IDENTIFIED MULTIPLE TEARS IN THE MEMBRANE AROUND THE PATIENT'S BOWELS. ACCORDING TO THE LEGAL DOCUMENT, THE SURGEON BELIEVED THIS BOWEL DAMAGE WAS CAUSED BY A GRASPER ON THE DA VINCI ROBOT HE USED. AFTER IDENTIFYING THE BOWEL DAMAGE, THE SURGEON REMOVED PART OF THE PATIENT'S COLON AND THEN REPAIRED THE PATIENT'S HERNIA. THE LEGAL DOCUMENT CLAIMS THAT AFTER THE SURGERY WAS COMPLETED, THE PATIENT REMAINED HOSPITALIZED AND HER MEDICAL CONDITION DECLINED DUE TO COMPLICATIONS FROM THE BOWEL SURGERY. ON (B)(6) 2012 THE SURGEON DECIDED TO PERFORM AN EXPLORATORY SURGERY AFTER A BUILDUP OF GAS WAS OBSERVED IN THE PATIENT'S ABDOMEN. THE EXPLORATORY SURGERY REVEALED THAT THE PATIENT'S SMALL AND LARGE BOWEL WERE FOUND TO BE DEAD. THE PATIENT

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI OVARIAN TRANSPOSITION PROCEDURE, A COMPLICATION OCCURRED AND THE PATIENT STARTED TO BLEED. THE SURGEON ATTEMPTED TO CONTROL BLEEDING BY APPLYING PRESSURE WITH AN INSTRUMENT GRASPER AND APPLYING LAPAROSCOPIC LIGACLIPS. THE LIGACLIPS FAILED TO CONTROL THE BLEEDING AND THE SURGEON ATTEMPTED TO SUTURE THE VESSEL, BUT THIS WAS ALSO UNSUCCESSFUL AT CONTROLLING BLEEDING. THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES. THE SURGICAL STAFF UNDOCKED THE CAMERA ARM AND ONE OF THE INSTRUMENT ARMS FROM THE PATIENT BUT KEPT THE OTHER TWO ARMS WITH THE INSTRUMENTS IN THE PATIENT. THE INSTRUMENTS ARMS WERE APPLYING PRESSURE TO THE SITE OF BLEEDING. THE SURGEON ATTEMPTED TO FIND THE SOURCE OF BLEEDING. IT IS UNCLEAR ON THE SEQUENCE OF EVENTS AFTER THIS. THE PATIENT WAS CONFIRMED TO HAVE EXPIRED. IT IS UNKNOWN WHETHER THE PATIENT EXPIRED DURING OR AFTER THE PROCEDURE. NO FURTHER 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 HYSTERECTOMY PROCEDURE ON (B)(6) 2012 FOR ENDOMETRIAL ADENOCARCINOMA. ACCORDING TO THE LEGAL DOCUMENT, THE PATIENT REPORTEDLY SUSTAINED A PUNCTURE TO HER BLADDER AND INTESTINES DURING THE DA VINCI SURGERY AND SUBSEQUENTLY DIED ON AN UNSPECIFIED DATE. IN ADDITION TO THE LEGAL DOCUMENT, ISI WAS PROVIDED WITH THE OPERATIVE REPORTS OF THE PRIMARY DA VINCI HYSTERECTOMY PROCEDURE AND A SECONDARY OPERATION THAT OCCURRED ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED. ACCORDING TO THE (B)(6) 2012 DA VINCI SURGERY OPERATIVE REPORT, THERE WAS AN INTRAOPERATIVE COMPLICATION, NAMELY A SMALL INADVERTENT CYSTOTOMY, WHICH WAS RECOGNIZED AND REPAIRED BY A UROLOGIST DURING THE INITIAL OPERATION. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING SURGERY IN THE OPERATIVE REPORT. IT IS UNKNOWN WHEN THE PATIENT WAS DISCHARGED AFTER THE DA VINCI SURGERY. ON (B)(6) 2012, THE PATIENT RETURNED TO SURGERY FOR ACUTE ABDOMINAL PAIN. PERFORATED VISCUS WAS SEEN. RESECTION OF TERMINAL ILEUM AND ILEOSTOMY WERE PERFORMED BY

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 1 DAY POST-OP, A SUCCESSFUL DA VINCI SI LYSIS OF ADHESIONS PROCEDURE, THE PATIENT EXHIBITED SIGNS OF CELLULITIS AT ONE OF THE TROCAR SITES AND EXPERIENCED DECREASED URINE OUTPUT. A CT SCAN PERFORMED SHOWED THE PATIENT HAD NORMAL GASTROINTESTINAL AND GENITOURINARY TRACT, HOWEVER, WITHIN A FEW HOURS, THE PATIENT'S HEALTH BEGAN TO DETERIORATE AND WAS TAKEN TO THE ICU. SEVERAL SPECIALISTS CONSULTED SUSPECTED THAT THE PATIENT HAD NECROTIZING FASCIITIS AND THE PATIENT WAS THEN TAKEN TO THE OPERATING ROOM. THE GENERAL SURGEON CONSULTED FOUND THAT THE PATIENT'S SMALL BOWEL HAD A PERFORATION. THE PATIENT HAD DEVELOPED SEPTIC SHOCK, ACIDOSIS AND EXPIRED. IT IS THE SURGEON'S BELIEF THAT THE INFECTION DEVELOPED BY THE PATIENT WAS VERY ATYPICAL PRESENTATION FOR PERITONITIS AND PERFORATION AND THAT MAYBE THE PATIENT'S IMMUNOSUPPRESSIVE STATUS CAUSED THE EVENT, AS DAMAGE TO THE PATIENT'S BOWEL WAS NOT THERMAL DAMAGE AND WAS NOT CAUSED BY THE TROCAR AS SHE PERFORMED AN OPEN ENTRY. THE DELAY IN REPORTING IS DUE TO AN OVERSIGHT IN INITIAL CAPTURING OF THE COMPLAINT BY ISI CUSTOMER SERVICE.

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 EXPIRED 5 DAYS AFTER UNDERGOING A DA VINCI SI TONGUE BASE RESECTION PROCEDURE ON (B)(6), 2012. NO ISSUES OCCURRED DURING THE SURGICAL PROCEDURE AND THE PATIENT WAS RELEASED 3 DAYS POST-OP. THE PATIENT WAS DOING WELL AT THE TIME OF DISCHARGE, HOWEVER, HE WAS DISCOVERED TO HAVE PASSED AWAY TWO DAYS LATER AT HIS HOME.

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 NISSEN FUNDOPLICATION AND HIATAL HERNIA REPAIR PROCEDURE ON (B)(6) 2012. THE PATIENT REPORTEDLY SUSTAINED A LACERATION TO THE PORTAL VEIN DURING THE SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY ON (B)(6) 2012. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR THE PATIENT'S MEDICAL RECORDS. ACCORDING TO THE LEGAL DOCUMENT PROVIDED, WHILE THE SURGEON WAS DISSECTING AWAY MESENTERY IN THE AREA OF THE LESSER CURVATURE OF THE STOMACH, SIGNIFICANT BLEEDING WAS ENCOUNTERED AND A LATERAL LACERATION TO THE MEDIAL ASPECT OF THE PORTAL VEIN WAS THEN IDENTIFIED. AFTER RECOGNIZING THE VESSEL INJURY, THE SURGEON MADE THE DECISION TO CONVERT TO AN OPEN PROCEDURE AND ENTERED THE PATIENT'S ABDOMEN THROUGH A VERTICAL MIDLINE INCISION. VASCULAR SURGERY WAS THEN CONTACTED FOR ASSISTANCE. WHILE VASCULAR SURGERY WAS EN ROUTE, THE SURGEON CROSS CLAMPED THE PORTAL VEIN, PROCEEDED WITH THE NISSEN FUNDOPLICATION PROCEDURE, AND COMPLETED THE ORIGINALLY INTENDED PROCEDURE. UPON ARRIVING IN THE OPERATING ROOM, A VASCULAR SURGEON IDENTIFIED A LATERAL LACERATION TO THE MEDIAL ASPECT OF