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) 2014, THE REPORTER INFORMED INTUITIVE SURGICAL, INC. (ISI) OF A PATIENT WHO REPORTEDLY EXPERIENCED A SIMILAR POST DA VINCI COURSE AS THE PATIENT WHO SUSTAINED NEURO-SOMATIC SYMPTOMS FOLLOWING A DA VINCI MYOMECTOMY PROCEDURE REPORTED IN MFR REPORT 2955842-2013-04307 (PATIENT IDENTIFIER (B)(6)). THE REPORTER WAS UNWILLING TO PROVIDE ANY ADDITIONAL DETAILS. THERE WAS NO ALLEGATION OF A MALFUNCTION WITH THE DA VINCI SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES. THE PATIENT'S AGE/WEIGHT, DA VINCI SYSTEM SERIAL , PROCEDURE TYPE, EVENT DATE, AND POST DA VINCI COURSE DETAILS WERE NOT PROVIDED. ADDITIONAL ATTEMPTS HAVE BEEN MADE TO CONTACT THE REPORTER FOR MORE INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN 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 POST A DA VINCI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND PARA AORTIC NODE DISSECTION PROCEDURE PERFORMED ON (B)(6) 2014 THE PATIENT UNDERWENT A SECOND SURGICAL PROCEDURE DUE TO INFARCTION OF THE RIGHT COLON. THE DATE OF THE PATIENT'S DEMISE WAS NOT REPORTED AND IT IS THE SURGEON'S BELIEF THAT THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. ACCORDING TO THE SURGEON THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES THAT CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE. THE PATIENT HAD UTERINE CANCER AND BOWEL ISCHEMIA. THE SURGEON INDICATED THAT THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES, BUT WAS CAUSED BY THE PATIENT'S BOWEL ISCHEMIA. DUE TO HIPPA REGULATIONS, THE SURGEON DECLINED TO PROVIDE ANY OTHER INFORMATION REGARDING THE PATIENT.

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 HYSTERECTOMY WITH BILATERAL PELVIC AND PARA-AORTIC LYMPHADENECTOMY PROCEDURE FOR ENDOMETRIAL CANCER STAGING, THE PATIENT SUSTAINED A URETERAL INJURY. THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CLINICAL FELLOW, THE DA VINCI FLUORESCENCE IMAGING VISION SYSTEM WAS BEING USED DURING AN INSTITUTIONAL REVIEW BOARD (IRB) APPROVED RESEARCH PROTOCOL IN WHICH A PATIENT RECEIVED A CERVICAL INTERSTITIAL INJECTION OF INDOCYANINE GREEN (ICG) FOR THE PURPOSE OF SENTINEL LYMPH NODE MAPPING. DURING DISSECTION OF A SENTINEL LYMPH NODE FROM THE LEFT PARA-AORTIC LYMPH NODE CHAIN AND WHILE THE SURGEON WAS OPERATING IN THE FLUORESCENCE IMAGING MODE, A 2MM THERMAL INJURY TO THE LEFT URETER AT THE LEVEL OF THE INFERIOR MESENTERIC ARTERY OCCURRED. THE CLINICAL FELLOW INDICATED THAT THE INJURY OCCURRED BECAUSE VISUALIZATION WAS POOR DUE TO BLEEDING (CONTAMINATING THE SURGICAL FIELD) AND BECAUSE THE LEFT URETER, WHICH HAD ORIGINALLY BEEN IDENTIFIED AND RETRACTED BY THE 3RD ARM, SLIPPED OUT FROM ITS RETRACTION INTO THE SURGICAL FIELD. AT THE TIME THE INJURY OCCUR

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 AFTER COMPLETION OF A DA VINCI SACROCOLPOPEXY PROCEDURE, THE PATIENT PRESENTED WITH AN UNSPECIFIED SMALL BOWEL INJURY POST-OPERATIVELY. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THERE WERE NO REPORTS FROM THE SURGICAL STAFF THAT ANY INTRA-OPERATIVE COMPLICATIONS OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. IN ADDITION, THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2014, THE PATIENT RETURNED TO THE HOSPITAL AND UNDERWENT AN EXPLORATORY LAPAROTOMY. DURING THE PROCEDURE, THE PATIENT UNDERWENT REPAIR OF THE SMALL BOWEL INJURY. NO ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI TOTAL COLECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A POSSIBLE THERMAL BURN TO THE SMALL BOWEL POST-OPERATIVELY. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE POST-OPERATIVE COMPLICATION WAS IDENTIFIED ON POST-OPERATIVE DAY 11. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE CSR, HE WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS OBSERVED AND NO REPORTS OF ANY ARCING OF ENERGY FROM AN INSTRUMENT. ON (B)(6) 2015, ISI CONTACTED THE SITE'S ROBOTICS COORDINATOR. SHE INDICATED THAT SHE WAS IN AND OUT OF THE DA VINCI SURGICAL PROCEDURE. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS OR ISSUES WITH THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES. TO HER KNOWLEDGE, THE PATIENT WAS TAKEN BACK TO THE OR ON AN UNSPECIFIED DATE FOR REPAIR OF A POSSIBLE THERMAL INJURY TO THE SMALL BOWEL. THE ROBOTICS COORDINATOR DID NOT KNOW WHAT THE SUSPECTED CAUSE WAS FOR THE THERMAL INJURY. AFTER THE THERMAL INJURY WAS REPAIRED, THE PATIE

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 HYSTERECTOMY PROCEDURE, WHILE THE SURGEON WAS UTILIZING A MONOPOLAR CURVED SCISSORS INSTRUMENT AND A FENESTRATED BIPOLAR FORCEPS INSTRUMENT, THE PATIENT SUSTAINED A THERMAL INJURY TO HER RECTUM. THE SURGEON CONSULTED A GENERAL SURGEON TO EVALUATE THE DEFECT. AFTER EXAMINING THE PATIENT'S RECTUM, THE GENERAL SURGEON DETERMINED THAT THE AFFECTED AREA DID NOT REQUIRE ANY TREATMENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. APPROXIMATELY 5 DAYS POST-OP AND DURING THE PATIENT'S HOSPITALIZATION, THE PATIENT COMPLAINED OF PAIN. EXAMINATION OF THE PATIENT FOUND THAT THE PATIENT HAD DEVELOPED A RECTAL CERVICAL FISTULA. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION FROM THE SURGEON WHO PERFORMED THE DA VINCI HYSTERECTOMY PROCEDURE. ACCORDING TO THE SURGEON THE PATIENT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE DUE TO FIBROIDS, MENORRHAGIA AND ANEMIA. THE PATIENT'S UTERUS WEIGHED 615 GRAMS AND WAS 20 WEEKS IN SIZE. THE SURGEON INDICATED THAT AFTER THE PATIENT'S UTERUS HAD BEEN MORCELLATED AND REMOVED, HE IDENTIFIED A WHITE SPOT ON THE PATIENT'S SIGMOID COLON THAT WAS CLOSE TO THE UTERINE CERVIX JUNCTION. WHILE THE GE

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 AFTER COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT WAS SENT HOME AND THEN LATER PRESENTED WITH A POSSIBLE BOWEL INJURY. THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE.

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 OVARIAN CYSTECTOMY PROCEDURE, THE PATIENT'S BOWEL WAS INJURED. ACCORDING TO THE INITIAL REPORTER, THE INSTRUMENTS WERE INSTALLED IN THE PATIENT WITH THE SURGEON AT THE PATIENT SIDE CONSOLE (PSC) UNDER SCOPE VISUALIZATION. WHEN THE SURGEON SAT DOWN AT THE SURGEON SIDE CONSOLE (SSC), SHE WAS UNABLE TO SEE THE SCISSORS INSTALLED ON PATIENT SIDE MANIPULATOR (PSM1) 1. THE SURGEON MOVED THE CAMERA TO LOOK FOR THE SCISSOR TIPS. THE INITIAL REPORTER INDICATED THAT THE SURGEON FOUND THAT THE SCISSORS HAD NICKED/PUNCTURED THE PATIENT'S BOWEL. THE INITIAL REPORTER ALSO INDICATED THAT THEY WERE COMPLETING THE DA VINCI SURGICAL PROCEDURE AND ANOTHER SURGEON WAS GOING TO PERFORM THE BOWEL REPAIR USING THE DA VINCI SYSTEM. AT AN UNSPECIFIED TIME DURING THE EVENT, THE SURGICAL STAFF NOTICED THAT THE CANNULA ON PSM1 HAD BECOME DISCONNECTED.

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 06/02/2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE (B)(4) BLOG TITLED, (B)(4). ACCORDING TO THE INTERNET BLOG, THE PATIENT ALLEGED THAT SHE EXPERIENCED MULTIPLE POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2014. THE INTERNET BLOG DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE OPERATIVE COMPLICATIONS. REFER TO THE FOLLOWING INTERNET LINK FOR ACCESS TO THE INTERNET BLOG: (B)(4). BASED ON THE INTERNET BLOG, THE FOLLOWING INFORMATION WAS PROVIDED: THE PATIENT INDICATED THAT SHE WAS SENT HOME THE SAME DAY AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE. POST-OPERATIVELY, THE PATIENT CLAIMED THAT SHE EXPERIENCED BLADDER AND PELVIC PAIN. AFTER CONSULTING WITH HER SURGEON, THE PATIENT INDICATED THAT SHE WAS INSTRUCTED TO GO TO THE ER ON POST-OPERATIVE DAY 4 OR 5. WHILE IN URGENT CARE, THE PATIENT WAS FOUND TO HAVE A BLADDER INFECTION. SINCE UNDERGOING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT INDICATED THAT SHE HAS HAD MULTIPLE EXAMS AND RADIOLOGIC TESTS PERFORMED ON HER PELVIS AND BLADDER. A YEAR AND

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 SURGICAL PROCEDURE, THE PATIENT'S RECTUM WAS DAMAGED AND AS A RESULT OF THE INJURY TO THE PATIENT, THE SURGEON MADE THE DECISION TO CONVERT THE SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES TO REPAIR AND COMPLETE THE PROCEDURE. REPORTEDLY, THE INJURY TO THE PATIENT WAS DUE TO THE PATIENT'S ANATOMY. THERE WAS NO REPORT OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES. THE PATIENT HAD CANCER, WHICH MADE IT DIFFICULT FOR THE SURGEON TO DELINEATE THE SURGICAL PLANES. NO OTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2014, AN INTUITIVE SURGICAL, INC. (ISI) SALES REPRESENTATIVE BECAME AWARE OF AN INJURY THAT OCCURRED DURING A DA VINCI RIGHT UPPER LOBECTOMY PROCEDURE THAT TOOK PLACE ON (B)(6) 2014 FROM A DOCTOR WHO WAS PRESENT DURING THE CASE. THE DOCTOR INDICATED THAT THE SURGEON PERFORMING THE DA VINCI SURGICAL PROCEDURE ENCOUNTERED AN INJURY TO A BRANCH OF THE PULMONARY ARTERY, WHICH BLED UNCONTROLLABLY. THE DA VINCI PROCEDURE WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE AND THE PATIENT WAS GIVEN AN EMERGENCY HEART AND LUNG BYPASS. THE PATIENT LOST >40 UNITS OF BLOOD AND WAS GIVEN A BLOOD TRANSFUSION. THE PATIENT ALSO DEVELOPED ABDOMINAL COMPARTMENT SYNDROME AND WAS REOPENED AT THE SAME PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME. ON (B)(6) 2014, ISI CONTACTED THE SITE'S RISK MANAGEMENT. THE RISK MANAGER INDICATED THAT THE PATIENT'S INJURY WAS NOT RELATED TO ANY ISSUES OR MALFUNCTIONS OF THE DA VINCI SYSTEM. SHE DECLINED TO PROVIDE ANY OTHER INFORMATION.

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 SACROCOLPOPEXY PROCEDURE, THE PATIENT'S ILIAC VESSEL WAS INJURED AND THE PATIENT EXPIRED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI NEPHRECTOMY PROCEDURE, THE SURGEON NICKED AN UNSPECIFIED VESSEL RESULTING IN THE PATIENT RECEIVING A BLOOD TRANSFUSION. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S ROBOTICS COORDINATOR. THE ROBOTICS COORDINATOR STATED THAT THE INJURY TO THE PATIENT'S VESSEL WAS DUE TO SURGEON ERROR. SHE STATED THAT NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ACCORDING TO THE ROBOTICS COORDINATOR, THE SURGEON REPAIRED THE VESSEL INJURY AND THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED. THE PATIENT WAS DISCHARGED HOME ON POST-OPERATIVE DAY 3 AND THERE WERE NO REPORTS OF ANY POST-OPERATIVE COMPLICATIONS.

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 CHOLECYSTECTOMY ON (B)(6) 2014 AND SUSTAINED AN INTRA-OPERATIVE PERFORATION. ACCORDING TO THE LEGAL DOCUMENT PROVIDED, THE PATIENT PASSED AWAY ON (B)(6) 2014 DUE TO COMPLICATIONS OF BACTERIAL SEPSIS. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR THE PATIENT'S MEDICAL RECORDS.

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 AFTER COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL WITH COMPLAINTS OF ABDOMINAL PAIN. THE PATIENT WAS EVALUATED IN AN EMERGENCY ROOM (ER), TREATED WITH AN ANTIBIOTIC, AND SENT HOME. ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR). THE CSR WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE CSR STATED THAT AFTER THE EVENT OCCURRED, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE ON AN UNSPECIFIED DATE. ACCORDING TO THE CSR, THE FSE AND THE SITE'S BIOMED DEPARTMENT EVALUATED THE DA VINCI SYSTEM INVOLVED WITH THIS COMPLAINT AND NO ISSUES WERE FOUND. THE CSR WAS UNABLE TO PROVIDE THE DATE OF THE SURGICAL PROCEDURE INVOLVED WITH THIS COMPLAINT.

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 COMPLETION OF A DA VINCI NISSEN FUNDOPLICATION AND PARA-ESOPHAGEAL REPAIR PROCEDURE, THE PATIENT RETURNED TO THE ICU ON POST-OPERATIVE DAY 3. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. HOWEVER, THE PATIENT SUBSEQUENTLY PASSED AWAY ON (B)(6) 2014. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT. THE INITIAL REPORTER INDICATED THAT HE WAS PRESENT DURING THE SURGICAL PROCEDURE AND NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY WAS OBSERVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT RETURNED TO THE HOSPITAL ON POST-OPERATIVE DAY 3 AND A PERFORATION OF HER STOMACH WAS FOUND. THE INJURY WAS REPAIRED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 8 DAYS LATER. THE DAY AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT PASSED AWAY. THE INITIAL REPORTER DID NOT KNOW THE CAUSE OF THE PATIENT'S DEMISE. HE STATED THAT THE PATIENT HAD COMPROMISED HEALTH PRIOR TO UNDERGOING THE DA VINCI SURGICAL PROCEDURE. NO ADDITIONAL INFORMATION

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 HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY ON (B)(6) 2012 FOR DYSFUNCTIONAL UTERINE BLEEDING AND ENLARGING UTERINE FIBROIDS. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT (OP) AND THE OP REPORT FOR THE FOLLOWING LAPAROTOMY. NO MEDICAL HISTORY WAS PROVIDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE HYSTERECTOMY WAS PERFORMED WITH SEQUENTIAL CAUTERY AND TRANSECTION OF THE INFUNDIBULOPELVIC VESSELS, THE ROUND LIGAMENTS, AND THE BROAD LIGAMENTS. IT WAS NOTED DURING THE DISSECTION OF THE BLADDER FLAP THAT THERE WAS MINIMAL SCAR TISSUE FROM HER CESAREAN SECTION. THE CARDINAL LIGAMENTS AND UTERINE VESSELS WERE CAUTERIZED WITH PK CAUTERY AND CUT, AND THE COLPOTOMY MADE TO THE LEVEL OF THE KOH BASKET. THE UTERUS WAS REMOVED VAGINALLY AND THE VAGINAL CUFF CLOSED WITH VLOCK SUTURES. SURGERY WAS COMPLETED WITH NO COMPLICATIONS. ON (B)(6) 2013 PATIENT PRESENTED WITH FEELINGS OF WEAKNESS, PERSISTENT PAIN AND NAUSEA AND LOW GRADE TEMPERATURE AND RLQ MILD TENDERNESS. PATIENT WAS STA

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 PROSTATECTOMY PROCEDURE, THE PATIENT LOST 3500 CC'S OF BLOOD. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE DA VINCI SURGICAL PROCEDURE TOOK 10 HOURS. THE PATIENT WAS TAKEN TO THE ICU AND THEN PASSED AWAY THE FOLLOWING DAY ON (B)(6) 2013. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S RISK MANAGER. THE RISK MANAGER INDICATED THAT THE SURGEON INVOLVED WITH THIS COMPLAINT WAS NO LONGER EMPLOYED BY THE SITE. ACCORDING TO THE RISK MANAGER, NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE RISK MANAGER STATED THAT AN AUTOPSY HAS BEEN PERFORMED AND THE CAUSE OF THE PATIENT'S DEATH WAS CARDIAC ARREST AND BLEEDING. THE RISK MANAGER INDICATED THAT THE SITE IS CURRENTLY REVIEWING THE CASE AND THE CAUSE OF THE INTRA-OPERATIVE BLEEDING IS UNDER INVESTIGATION. THE RISK MANAGER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE PATIENT OR REPORTED 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: ON (B)(4) 2014, AN INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVE BECAME AWARE OF A PATIENT WHO PASSED AWAY 11 DAYS AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE, HERNIA REPAIR, AND LAPARATOMY PROCEDURE. THE FOLLOWING INFORMATION WAS OBTAINED FROM THE SURGEON WHO PERFORMED THE DA VINCI SURGERY. ON (B)(6) 2013, A PATIENT UNDERWENT A DA VINCI HYSTERECTOMY WITH NODES DISSECTION PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY ON (B)(6) 2013. THE PATIENT REPORTEDLY DID NOT SUSTAIN ANY BOWEL INJURIES DURING THE DA VINCI SURGERY. ON (B)(6) 2013, THE SURGEON WHO PERFORMED THE DA VINCI SURGERY PERFORMED A HERNIA REPAIR ON THE PATIENT AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. ON (B)(6) 2014 MORNING, THE PATIENT RETURNED TO THE HOSPITAL WITH PAIN. SHE HAD AN UNSPECIFIED CT SCAN (RESULTS WERE NOT PROVIDED) AND AN ARTERIOGRAM (VESSELS WERE NORMAL). THE PATIENT UNDERWENT 2 CT SCANS AND LATER WENT INTO RENAL FAILURE AND BECAME SEPTIC THE SAME DAY. THE PATIENT WAS TAKEN BACK TO SURGERY ON (B)(6) 2014 FOR A LAPAROTOMY, WHICH WAS WHEN THE INCARCERATED DISTAL ILEUM AND CECUM WERE IDENTIFIED. ON (B)(6) 2014 MIDNIGHT, THE PATIENT CODED AND WAS RESUSCITATED. A

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 HYSTERECTOMY PROCEDURE, THE SURGEON MADE AN INCISION INTO THE PATIENT'S BLADDER WHICH WAS ADHERED. THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT THE INCISION WAS CREATED WHILE THE SURGEON WAS PERFORMING A COLPOTOMY. THE BLADDER INJURY WAS RECOGNIZED AND REPAIRED BY A UROLOGIST. THE UROLOGIST NOTED NORMAL FUNCTION OF BOTH URETHRAL SPHINCTERS WITH THE USE OF DYE AND THE BLADDER DEFECT WAS CLOSED WITH SUTURES. THE INITIAL REPORTER INDICATED THAT THE PATIENT WAS DOING OK POST-OPERATIVELY. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER. THE INITIAL REPORTER STATED THAT THE BLADDER INJURY WAS DUE TO A SURGICAL ERROR. ACCORDING TO THE INITIAL REPORTER, THE SURGEON DID NOT REALIZE THAT THE BLADDER WAS STILL ADHERED AND INADVERTENTLY CREATED A NICKEL SIZED INCISION IN THE PATIENT'S BLADDER. THE INITIAL REPORTER ALSO STATED THAT NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE INITIAL REPORTER INDICATED THAT A DRAIN WAS PLACED DURING THE REPAIR AND WAS REMOVED ON POST-OP DAY 1 OR 2. THE PATIENT WAS DISCHARGED AND NO POST-OPERATIVE COMPLICATIONS WERE 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: I UNDERWENT A ROUTINE BLADDER SLING SURGERY APPROX (B)(6), 2013 AT (B)(6) HOSPITAL IN (B)(6). (B)(6) USED THE DA VINCI ROBOT TO PERFORM THE SURGERY. AS THE ROBOTIC ARM WAS RE-POSITIONING MY SMALL INTESTINE, THE ROBOT SLICED MY SMALL INTESTINE WITHOUT THE SURGEON KNOWING IT. ACCORDING TO THE SURGEON, THE ROBOT STOPPED VIDEO TAPING THE PROCEDURE HALF WAY THROUGH SO HE WAS UNABLE TO DETERMINE WHAT HAD HAPPENED. EMERGENCY LIFE SAVING SURGERY WAS PERFORMED ON (B)(6), 2013 BY THE RESIDENT SURGEON TO REPAIR THE TEAR. IT IS NOW 3 MONTHS POST PROCEDURE AND I STILL HAVE NOT BEEN ABLE TO RETURN TO WORK AS I STILL HAVE AN OPEN ABDOMINAL WOUND. PLEASE, I RESPECTFULLY ASK THAT YOU TAKE THE DA VINCI ROBOT OFF THE MARKET AND NOT LET IT HARM ANY FURTHER PEOPLE. MY HOSPITAL BILLS ARE NEARING (B)(6).

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 DIED AFTER UNDERGOING A DA VINCI RIGHT UPPER LOBE WEDGE RESECTION PROCEDURE FOR A LUNG MASS ON (B)(6) 2013. ACCORDING TO THE LEGAL DOCUMENTS, IT WAS ALLEGED THAT DUE TO A DEFECTIVE DESIGN OF THE DA VINCI SURGICAL SYSTEM, THE PATIENT SUSTAINED AN ARTERY INJURY TO THE RIGHT INTERNAL JUGULAR VEIN. AS A RESULT, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AND DETERIORATED TO ASYSTOLE, AND SUBSEQUENTLY PASSED AWAY AT THE END OF THE PROCEDURE. ISI RECEIVED THE PATIENT'S DA VINCI OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT WAS PREVIOUSLY TREATED WITH CHEMOTHERAPY AND RADIATION IN THE LEFT LOWER LOBE FOR STAGE III LUNG CANCER AND WAS PRESENTED WITH A NEW ENLARGING LESION IN THE UPPER MEDIASTINUM/RIGHT UPPER LOBE. AFTER THE DA VINCI SYSTEM WAS DOCKED TO THE PATIENT, THE PATIENT'S CHEST WAS EXPLORED AND NO METASTATIC TISSUE WAS FOUND. A MASS WAS IDENTIFIED IN THE RIGHT UPPER LOBE FIRMLY ADHERENT TO THE MEDIASTINUM, AT THE APEX OF THE CHEST, AT THE SUPERIOR MEDIASTINUM. THE PLEURA OVER THIS AREA WAS INCISED WITH BIPOLAR CAUTERY. DURING 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI-ASSISTED TOTAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL PELVIC LYMPHADENECTOMY, AND PARA-AORTIC LYMPHADENECTOMY FOR OVARIAN CANCER ON (B)(6) 2013. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING THE DA VINCI SURGERY. PER THE SURGICAL NOTE, THE ABDOMEN WAS FIRST ENTERED BY SCOPE AT THE LEVEL OF THE LEFT UPPER QUADRANT RIGHT BELOW THE RIB CAGE IN ORDER TO OBSERVE IF THERE WERE ADHESIONS FROM THE PREVIOUS CHOLECYSTECTOMY IN THE UPPER ABDOMEN CLOSE TO THE UMBILICUS, BECAUSE SHE PRESENTED A LARGE SCAR. ADHESIONS WERE SEEN AND LYSED BY ENDO SHEARS AND MONOPOLAR CURRENT OVER A 10-15 MINUTE TIME BEFORE THE CAMERA COULD BE INSERTED. SURGICAL FINDINGS ALSO NOTED ENLARGED LYMPH NODES SUSPICIOUS FOR MALIGNANCY AND AN ENLARGED FIBROID UTERUS THAT REQUIRED MORCELLATION FOR REMOVAL. THE PATIENT WAS DISCHARGED ON (B)(6) 2013. SHE WAS INSTRUCTED TO FOLLOW UP WITH THE SURGEON IN 7-10 DAYS. AROUND (B)(6) 2013,

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 AFTER A DA VINCI HYSTERECTOMY PROCEDURE A PROBLEM WAS IDENTIFIED AND THE PATIENT WAS TAKEN BACK INTO SURGERY FOR AN EXPLORATORY LAPAROTOMY TO LOOK FOR A BOWEL INJURY.

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, AN INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVE REPORTED A TRANSVERSE COLON INJURY THAT WAS OBSERVED AFTER A PATIENT WHO UNDERWENT A DA VINCI CHOLECYSTECTOMY SURGICAL PROCEDURE ON (B)(6) 2013. THE PATIENT UNDERWENT ANOTHER UNSPECIFIED SURGERY ON AN UNKNOWN DATE. NO OTHER DETAILS WERE PROVIDED AT THE TIME. ON (B)(4) 2014, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE INITIAL REPORTER: THE PATIENT WAS A MALE WHO WAS (B)(6) (WEIGHT=UNKNOWN). THE INITIAL REPORTER SPOKE WITH THE SITE AND WAS NOT INFORMED OF ANY INTRA-SURGICAL COMPLICATIONS OR MALFUNCTIONS OF THE DA VINCI SYSTEM AND/OR INSTRUMENT/ACCESSORIES. ON AN UNSPECIFIED DATE FOLLOWING THE DA VINCI SURGICAL PROCEDURE, THE PATIENT STARTED TO FEEL SICK. TWO DAYS POST DA VINCI SURGERY ((B)(6) 2013), THE SAME DA VINCI SURGEON PERFORMED AN OPEN EXPLORATORY SURGERY AND FOUND THE PATIENT'S TRANSVERSE COLON WAS CUT. THE INJURY WAS REPAIRED AND THE PATIENT WAS HOSPITALIZED FOR A COUPLE WEEKS. PATIENT WAS DISCHARGED AROUND (B)(6) 2014 TO A REHAB FACILITY FOR AN UNDETERMINED TIME PERIOD. THE SURGEON DOES NOT KNOW WHEN THE INJURY OCCURRED AND HOW IT HAPPENED BUT BELIEVES THE INJURY MAY BE RELATED TO USE ERROR (INS

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 AFTER COMPLETION OF A DA VINCI SURGICAL PROCEDURE, A NURSE'S FINGERS WERE INJURED WHILE MANEUVERING THE PATIENT SIDE CART (PSC). ACCORDING TO THE INITIAL REPORTER, THE NURSE WAS HAVING DIFFICULTY CONTROLLING THE ACCELERATION OF PSC AND THE NURSE'S FINGERS WERE INJURED BECAUSE THE PSC DID NOT STOP AS THE CUSTOMER HAD EXPECTED. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED DUE TO THE REPORTED EVENT. THE TSE ADVISED THE SITE NOT TO THROTTLE FULLY WHEN MANEUVERING THE PSC BACKWARDS. THE TSE ALSO ADVISED THE SITE TO STOP THE PSC WHEN THE PSC IS CLOSE TO THE END OF A WALL. ON (B)(6) 2013 AND (B)(6) 2014, ISI CONTACTED THE INITIAL REPORTER. THE INITIAL REPORTER EXPLAINED THAT THE NURSE'S FINGER GOT STUCK BETWEEN A HANDLE ON THE PSC AND A WALL WHILE TRYING TO MOVE THE PSC AGAINST THE WALL. HE ALSO INDICATED THAT THE NURSE UNDERWENT AN X-RAY AND NO FRACTURES WERE FOUND. ACCORDING TO THE INITIAL REPORTER, ONE OF THE NURSE'S FINGERS WAS FOUND TO BE BRUISED AND WRAPPED IN A BANDAGE. THE NURSE WAS ADDITIONALLY TREATED WITH 3 ANTIBIOTIC PILLS.

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 CHOLECYSTECTOMY PROCEDURE, THE SURGEON EXPERIENCED REPEATED INTERMITTENT DELAY AND NON-INTUITIVE MOTION WITH PATIENT SIDE MANIPULATOR ARM 2 (PSM2). THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. IT WAS REPORTED THAT THE PATIENT'S COMMON BILE DUCT WAS NICKED. HOWEVER, THE SURGEON STATED THAT THE INJURY TO THE PATIENT'S COMMON BILE DUCT WAS NOT RELATED TO THE PSM2 ISSUES. ON (B)(4) 2013, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER(FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE TESTED THE PSM INVOLVED WITH THIS COMPLAINT AND FOUND THE PSM SENSORS WERE FUNCTIONING PROPERLY. THE FSE WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THE FSE REVIEWED THE SYSTEM LOGS AND FOUND MULTIPLE 282 AND 31009 ERROR CODES. AN ERROR CODE 282 INDICATES THAT A TOOL WAS DETERMINED TO BE INVALID BY THE SYSTEM. AN ERROR CODE 31009 INDICATES TOOL WAS FULLY DETECTED, AND THEN ONE OR MORE (BUT NOT ALL) OF THE TOOL SENSORS WERE NOT DETECTED FOR 3 SECONDS. THE FSE EXPLAINED THAT THE REPORTED PSM ISSUES WERE MOST LIKELY RELATED TO AN ISSUE WITH THE STERILE ADAPTER. HOWEVER 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: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI SIGMOID COLECTOMY PROCEDURE, THE DA VINCI SYSTEM WAS UNDOCKED FROM THE PATIENT WHEN THE SURGEON REALIZED HE DID NOT GET ALL THE DISEASED PORTIONS FROM THE PATIENT. THE SURGEON DECIDED TO PERFORM A TRADITIONAL OPEN SURGICAL PROCEDURE TO REMOVE THE DISEASED ANATOMY. AT THE TIME THE SURGEON MADE THE DECISION TO PERFORM THE OPEN SURGICAL PROCEDURE, THE INITIAL REPORTER WAS NO LONGER IN THE OPERATING ROOM (OR), HOWEVER IT WAS INDICATED THAT THE ENTIRE SURGERY LASTED A COUPLE OF HOURS. ON AN UNSPECIFIED DATE, THE PATIENT WAS RELEASED FROM THE HOSPITAL, HOWEVER, THE PATIENT LATER NOTIFIED THE SURGEON OF COMPLAINTS OF NUMBNESS TO HIS LEFT ARM. ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON. THE SURGEON INDICATED THAT THE ARM NUMBNESS WAS IN THE DISTRIBUTION OF THE MEDIAN NERVE AND HAD SINCE BEEN RESOLVED. THERE WERE NO OTHER REPORTED POST-OPERATIVE COMPLICATIONS. THE SURGEON REPORTEDLY ORDERED A CERVICAL SPINE MRI WHICH SHOWED THAT THE PATIENT HAD A CERVICAL DISK BULGING IN C4 THROUGH C7, BUT THERE WAS NO DIRECT NERVE IMPINGEMENT. ACCORDING TO THE SURGEON, THE SURGICAL PROCEDURE LASTED 6-7 HOURS AND THE PATIENT WAS N

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 AFTER COMPLETION OF A DA VINCI PROSTATECTOMY PROCEDURE, A PATIENT RETURNED TO THE HOSPITAL 3 DAYS LATER AND WAS FOUND TO HAVE SUSTAINED A COLON INJURY. THE INITIAL REPORTER OF THIS COMPLAINT, THE ROBOTICS COORDINATOR, INDICATED THAT THE PATIENT UNDERWENT A DIVERTING COLOSTOMY PROCEDURE. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ROBOTICS COORDINATOR FROM THE SITE. THE ROBOTICS COORDINATOR STATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE DA VINCI PROSTATECTOMY PROCEDURE. ACCORDING TO THE ROBOTICS COORDINATOR, THE PATIENT RETURNED TO THE HOSPITAL 3 DAYS POST-OPERATIVELY WITH COMPLAINTS OF ABDOMINAL PAIN AND FEVER. THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE AND WAS FOUND TO HAVE SEPSIS AND AN UNSPECIFIED COLON INJURY. THE ROBOTIC COORDINATOR STATED THAT A TEMPORARY COLOSTOMY WAS PLACED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ACCORDING TO THE ROBOTICS COORDINATOR, THE PATIENT WAS TO RETURN TO THE HOSPITAL AT A LATER DATE FOR FURTHER EVALUATION AND POSSIBLE PLACEMENT OF A BOWEL ANASTOMOSIS.

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 AFTER COMPLETION OF A DA VINCI MYOMECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE A SMALL BOWEL INJURY. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), A SURGEON FOUND THE SMALL BOWEL INJURY DURING A SUBSEQUENT OPEN PROCEDURE TO PERFORM A RESECTION OF THE BOWEL. THE SURGEON INDICATED THAT IT WAS HIS BELIEF THAT THE SMALL BOWEL INJURY WAS CLEARLY A THERMAL INJURY. THE CSR ALSO INDICATED THAT THE PATIENT EXPERIENCED FURTHER UNSPECIFIED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING THE OPEN BOWEL RESECTION PROCEDURE. ON (B)(4) 2013, ISI CONTACTED THE CSR. THE CSR WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. HOWEVER, THE CSR INDICATED THAT THE DA VINCI MYOMECTOMY PROCEDURE WENT SMOOTHLY AND THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE CSR STATED THAT THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL AND IS DOING FINE. THE CSR ALSO STATED THAT AFTER THE EVENT OCCURRED, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE ON AN UNSPECIFIED DATE. ACCORDING TO THE CSR, THE FSE AND THE SITE'S BIOMED DEPARTME

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 PROSTATECTOMY PROCEDURE ON (B)(6) 2013. DURING THE SURGICAL PROCEDURE, THE PLAINTIFF'S ATTORNEY CLAIMS THAT THE PATIENT SUSTAINED A PROBABLE BURN INJURY TO HIS BOWEL WHICH LATER CAUSED HIS DEATH. ISI WAS NOT PROVIDED WITH THE DA VINCI-ASSISTED OPERATIVE REPORT OR ANY MEDICAL RECORDS. 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 AT AN UNSPECIFIED TIME, EITHER DURING OR AFTER A DA VINCI GASTRIC BYPASS PROCEDURE, THE PATIENT EXPIRED. THE SURGEON INDICATED THAT THIS CASE WAS REVIEWED BY A COMMITTEE OF PEERS, ADMINISTRATORS, THE MEDICAL AND LEGAL DEPARTMENT AND IT WAS CONFIRMED THAT THE PATIENT'S DEATH WAS NOT RELATED TO A ROBOTIC COMPLICATION NOR WAS IT SURGICAL MISADVENTURE. NO FURTHER 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: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE ISCHEMIC COLITIS ON POST-OPERATIVE DAY 2. AS A RESULT OF THE ISCHEMIC COLITIS, THE PATIENT UNDERWENT AN OPEN COLON RESECTION PROCEDURE. THE SITE WAS UNSURE IF THE ISCHEMIC COLITIS WAS RELATED TO THE PATIENT'S HISTORY OF DIVERTICULITIS. ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR). THE CSR WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. HOWEVER, THE CSR STATED THAT THERE WAS NO REPORT FROM THE SITE THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE PATIENT CAME BACK TO THE HOSPITAL ON POST-OP DAY 2 WITH COMPLAINTS OF ABDOMINAL PAIN AFTER BEING DISCHARGED FROM THE HOSPITAL. THE CSR ALSO STATED THAT A COLOSTOMY WAS CREATED DURING THE OPEN RESECTION PROCEDURE. THE CSR DID NOT KNOW THE CURRENT STATUS OF THE PATIENT. THE CSR STATED THAT AFTER THE EVENT OCCURRED, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE ON AN UNSPECIFIED DATE. ACCORDING TO THE CSR, THE FSE AND THE SITE'S BIOMED DEPARTMENT EVALUATED THE DA VINCI

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 AFTER COMPLETION OF A DA VINCI CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE A BILE LEAK ON POST-OPERATIVE DAY 1 OR 2. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2013 TO REPAIR THE BILE LEAK. ON (B)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM DURING THE PROCEDURE AND THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. HOWEVER, THE CSR INDICATED THAT THE SURGICAL PROCEDURE WAS VERY DIFFICULT SINCE THE PATIENT HAD NUMEROUS ADHESIONS AND INFLAMMATION. THE CSR STATED THAT THE SURGEON, WHO PERFORMED THE DA VINCI CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2013, ALSO PERFORMED THE SURGICAL PROCEDURE USING THE DA VINCI SURGICAL SYSTEM TO REPAIR THE BILE LEAK ON (B)(6) 2013. ON (B)(6) 2013, ISI CONTACTED THE RISK MANAGER FROM THE SITE. THE RISK MANAGER INDICATED THAT NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. SHE STATED THAT BILE LEAKS ARE COMMON POST-OPERATIVE COMPLICATIONS AND THAT THE DA VINCI SURGICAL SYSTEM DID NOT CAUSE THE BILE LEAK

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 AND COMPLETE PELVIC LYMPHADENECTOMY PROCEDURE ON (B)(6) 2013 FOR STAGE 1B1 SQUAMOUS CELL CARCINOMA OF THE CERVIX. THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE DA VINCI SURGICAL SYSTEM INJURED THE PATIENT AND SPREAD UNDIAGNOSED UTERINE CANCER THROUGHOUT THE PATIENT'S BODY. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING THE DA VINCI SURGERY. NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED AND THE ESTIMATED BLOOD LOSS FROM THE SURGICAL PROCEDURE WAS 100 CC. THE SURGICAL PROCEDURE WAS COMPLETED AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. ON (B)(6) 2013, AND (B)(6) 2014, THE PATIENT UNDERWENT A CT-SCAN OF HER ABDOMEN AND PELVIS. THE IMPRESSION FROM (B)(6) 2013 CT-SCAN SHOWED NO DEFINITIVE EVIDENCE OF METASTATIC DISEASE. THE IMPRESSION FROM THE (B)(6) 2014 INCLUDED NEW CARCINOMATOSIS AND OMENTAL CAKING CONSISTENT WITH NEW METASTATIC

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 SURGICAL PROCEDURE, THE FIRST ASSISTANT INTRODUCED AN ENDOSCOPIC STAPLER INSTRUMENT THROUGH AN ASSISTANT PORT. REPORTEDLY, THE INSTRUMENT DID NOT GO ALL THE WAY ACROSS THE DORSAL VEIN COMPLEX, CAUSING THE PATIENT TO BLEED PROFUSELY. THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO OPEN SURGICAL TECHNIQUES; HOWEVER, THE PATIENT EXPIRED. NO OTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI CHOLECYSTECTOMY PROCEDURE, THE PATIENT SUSTAINED A BILE DUCT INJURY. THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL TO OPEN TECHNIQUES TO REPAIR AND COMPLETE THE SURGICAL PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGEON UNINTENTIONALLY NICKED THE PATIENT'S ARTERY AND CONVERTED TO TRADITIONAL OPEN SURGERY TO REPAIR THE ARTERY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A (B)(4) DATED (B)(4) 2013 AND TITLED, TROUBLE STILL WITH INCISION AREA AFTER BOTCHED DAVINCI SURGERY. FINALLY MY SURGEON ORDERED A CT SCAN AND SURE ENOUGH ... I HAVE A HERNIA! THE INTERNET POSTING CONTAINED THE FOLLOWING EVENT DESCRIPTION: TROUBLE STILL WITH INCISION AREA AFTER BOTCHED DAVINCI SURGERY. FINALLY MY SURGEON ORDERED A CT SCAN AND SURE ENOUGH ... I HAVE A HERNIA! I HAVE TO HAVE SURGERY AGAIN!!!! ANYONE ELSE GET HERNIA AFTER HYSTERECTOMY? WEB LINK: HTTPS://WWW.WHATNEXT.COM/QUESTIONS/TROUBLE-STILL-WITH-INCISION-AREA-AFTE R-BOTCHED-DAVINCI-SURGERY-FINALLY-MY-SURGEON-ORDERED-A-C T-SCAN-AND-SURE-ENOUGH-I-HAVE-A-HERNIA

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 MESH REVISION PROCEDURE USING THE DA VINCI SURGICAL SYSTEM, THE PATIENT EXPERIENCED BLEEDING FROM A VESSEL. THE AFFECTED VESSEL WAS REPAIRED INTRA-OPERATIVELY WITH THE DA VINCI SURGICAL SYSTEM. REPORTEDLY, THE SYSTEM WAS FUNCTIONING NORMALLY WHEN THE DAMAGE TO THE PATIENT'S VESSEL OCCURRED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO ADVERSE OUTCOME WAS REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PT WAS UNDERGOING ROBOTIC MYOMECTOMY AND RIGHT PARATUBAL CYSTECTOMIES USING THE DA-VINCI ROBOT. DURING ENUCLEATION OF ONE OF THE FIBROIDS, WHILE USING THE MONOPOLAR SPATULA, THE PULLEY SYSTEM FOR THE SPATULA BROKE. THE INSTRUMENT WAS REMOVED AND INSPECTED. IT WAS NOTED THAT 2 PIECES WERE MISSING: ONE PIECE WAS THE CIRCULAR GUARD WHICH COVERED THE WIRE PULLEY ON THE SIDE OF THE INSTRUMENT AND THE SECOND WAS THE OVERLYING FLANK WHICH COVERED THE CIRCULAR GUARD. THE SURGEON RETURNED TO THE SURGICAL SITE AND THE CIRCULAR GUARD WAS RECOVERED FROM THE PT. HOWEVER, THE FLANK PIECE COULD NOT BE LOCATED. AFTER EXHAUSTIVE EFFORTS TO LOCATE THE RETAINED PIECE AND DISCUSSION WITH THE PT'S FAMILY, IT WAS AGREED TO ALLOW THE PIECE TO REMAIN IN PLACE WITHOUT PROGRESSING TO MORE INVASIVE EFFORTS TO LOCATE THE PIECE.

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 COMPLETION OF A DA VINCI NISSEN FUNDOPLICATION AND CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE SUSTAINED AN ESOPHAGEAL PERFORATION ON POST-OP DAY 1. ON (B)(6) 2013, ISI CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE FIRST HALF OF THE SURGICAL PROCEDURE. DURING THE TIME THE CSR WAS PRESENT DURING THE CASE, SHE DID NOT WITNESS ANY INTRA-OPERATIVE COMPLICATIONS OR ISSUES WITH THE DA VINCI SURGICAL SYSTEM. ON (B)(6) 2013, THE CSR STATED THAT SHE SPOKE TO THE SURGEON AND WAS TOLD THAT THE PATIENT HAD PASSED AWAY. THE DATE AND CAUSE OF THE PATIENT'S DEMISE WAS NOT PROVIDED BY THE SURGEON. THE CSR INDICATED THAT THE SURGEON INFORMED HER THAT SHE FELT AS THOUGH THE DA VINCI SURGICAL PROCEDURES WENT WELL. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS OR A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY DURING THE SURGICAL PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CSR.

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 LOWER ANTERIOR RESECTION PROCEDURE PERFORMED ON (B)(6) 2013, THE SURGEON INDICATED THAT THE PATIENT EXPERIENCED A STROKE AND SUBSEQUENTLY PASSED AWAY ON AN UNSPECIFIED DATE. ACCORDING TO THE INITIAL REPORTER, THE SURGEON INFORMED HIM THAT THE PATIENT HAD MANY CO-MORBID CONDITIONS, WOKE UP BLIND, AND LATER PASSED AWAY. ON (B)(6) 2013, ISI CONTACTED THE RISK MANAGER (RM) AT THE SITE. THE RM REVIEWED THE PATIENT'S MEDICAL HISTORY AND NOTED THAT THE PATIENT HAD EXPERIENCED MULTIPLE STROKES IN THE PAST PRIOR TO UNDERGOING THE DA VINCI SURGICAL PROCEDURE ON (B)(6) 2013. THE PATIENT'S MEDICAL HISTORY INCLUDED PROSTATE CANCER, ABDOMINAL ANEURYSMS, AORTIC ANEURYSM, CORONARY ATHEROSCLEROSIS, HEART DISEASE, COLON CANCER, HYPERTENSION, DIASTOLIC DYSFUNCTION, AND CHRONIC TOBACCO USE. THE RM ALSO REVIEWED THE OPERATIVE REPORT AND DID NOT FIND ANY NOTATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ACCORDING TO THE OPERATIVE REPORT, THERE WERE NO COMPLICATIONS AND THE PATIENT TOLERATED THE PROCEDURE WELL. BASED ON THE PATIENT'S MEDICAL RECORDS, THE PATIENT WOKE UP POST-OPERATIVELY WITH CO

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, THE USER FACILITY CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) DURING A DA VINCI MYOMECTOMY PROCEDURE AND REQUESTED HER TO COME IN BECAUSE MULTIPLE INSTRUMENTS KEPT BREAKING. WHEN THE CSR ARRIVED, SHE NOTED THAT THE PORT PLACEMENT WAS INCORRECT FOR THE TYPE OF SURGICAL PROCEDURE AND THE VISION WAS OBSCURED, NOT ALLOWING THE INSTRUMENT TIPS TO BE VIEWED. THE CSR STATED THAT THE SURGEON WAS RESISTANT TO HER RECOMMENDATIONS BUT FINALLY AGREED TO MOVE THE CAMERA PORT FOR A BETTER VIEW OF THE INSTRUMENTS. ACCORDING TO THE CSR, THE SURGEON REPEATEDLY OVER ROTATED THE MASTER TOOL MANIPULATOR (MTM) AND KEPT LOSING VIEW OF THE INSTRUMENT'S TIPS. THE MASTER TOOL MANIPULATOR REFERS TO THE MASTER CONTROLLERS WHICH PROVIDE THE MEANS FOR THE SURGEON TO CONTROL THE INSTRUMENTS AND ENDOSCOPE INSIDE THE PATIENT FROM THE SURGEON SIDE CONSOLE. THE INSTRUMENTS WERE BEING PUSHED AGAINST THE MYOMA WITH ENOUGH FORCE THAT IT WAS CAUSING THE INSTRUMENTS TO BREAK. THE CSR STATED SHE WITNESSED THE INSTRUMENT CABLES BREAKING ON A MARYLAND BIPOLAR INSTRUMENT. THE CSR OBSERVED THAT THE VIEW OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TIPS WAS LOST AND THE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI RADICAL PROSTATECTOMY PROCEDURE IN OR ABOUT (B)(6) 2011. THE LEGAL DOCUMENT ALLEGES THAT THE 64 YEAR OLD MAN SUSTAINED SEVERE INTERNAL INJURIES, DAMAGE TO OTHER ORGANS, CONTINUING PAIN AND UNDERWENT ADDITIONAL SURGERIES TO ADDRESS THE SEVERE INTERNAL DAMAGES. NO OTHER DETAILS WERE PROVIDED REGARDING THE PATIENT'S INJURIES. THE LEGAL DOCUMENT NOTED THAT MONOPOLAR CURRENT WAS USED DURING THE DA VINCI PROSTATECTOMY PROCEDURE; HOWEVER, THERE WAS NO SPECIFIC ALLEGATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES. THE PATIENT DID NOT BELIEVE THE CAUSE OF HIS INJURIES WERE RELATED TO THE DA VINCI SYSTEM UNTIL (B)(6) 2013. THE PROVIDED INFORMATION DID NOT INCLUDE THE HOSPITAL NAME AND THE DETAILS OF THE DA VINCI SYSTEM INVOLVED WITH THE REPORTED EVENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE REPORTER IS A SURGEON WHO CALLED TO REPORT THAT SHE WAS PERFORMING A MYOMECTOMY (SURGICAL REMOVAL OF FIBROID FROM THE UTERUS) WITH A DA VINCI ROBOT. THE PROCEDURE WAS CONVERTED TO OPEN LAPAROTOMY BECAUSE THE FIBROID WAS TOO BIG. AFTER THE SURGERY X-RAY WAS TAKEN WHICH SHOWS A 1 CM METALIC PIECE OF THE TIP OF THE ROBOT, DETACHED AND IN THE OMENTUM, SHE TRIED LOOKING FOR THE TIP BEFORE CLOSING THE PT BUT COULD NOT FIND IT.

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 MYOMECTOMY PROCEDURE, THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE TO A LAPARATOMY TO COMPLETE THE DISSECTION OF A MASSIVE FIBROID FOR REMOVAL. A RADIOGRAPH WAS PERFORMED POST THE SURGICAL PROCEDURE DUE TO THE PATIENT'S BLOOD LOSS APPROXIMATELY 1000ML) AT WHICH TIME IT WAS DISCOVERED THAT THE PATIENT HAD RETAINED A 1CM LINEAR AND FRAYED METALLIC FOREIGN BODY. THE FOREIGN BODY WAS IN THE PATIENT'S RIGHT UPPER ABDOMEN QUADRANT, IN FRONT OF THE ASCENDING COLON AND DEEP INTO THE ABDOMEN WALL. A DIAGNOSTIC LAPAROSCOPY WITH FLUOROSCOPIC GUIDANCE CONFIRMED THAT THE FOREIGN OBJECT WAS WITHIN THE PATIENT'S OMENTUM. THE SURGEON STATED THAT THE FOREIGN OBJECT WAS A PIECE OF PULLEY TYPE WIRE ON THE WRISTED ARM OF THE INSTRUMENT. 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 HOURS AFTER A DA VINCI PARAESOPHAGEAL HERNIA PROCEDURE THE PATIENT HAD EXPIRED. IT WAS NOTED THAT THE PROCEDURE WAS CONVERTED TO TRADITIONAL OPEN SURGICAL TECHNIQUES FOR AN UNKNOWN REASON AND THAT THE PATIENT HAD CHRONIC PRE-EXISTING MEDICAL CONDITIONS THAT CONTRIBUTED TO THEIR DEATH. 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: ON (B)(6) 2013, A PATIENT UNDERWENT A DA VINCI MITRAL VALVE REPAIR PROCEDURE. THE SITE EXPERIENCED SEVERAL FAULTS WITH THE PATIENT SIDE MANIPULATOR ARM (PSM) 2 WITH THE DA VINCI SYSTEM AND CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT. THE FAULTS WERE RECOVERED AND THE SITE COMPLETED THE DA VINCI PROCEDURE. THE SITE WAS INFORMED THAT AN ISI FIELD SERVICE ENGINEER (FSE) WOULD COME OUT TO INSPECT THE DA VINCI SYSTEM. AT AN UNSPECIFIED TIME AFTER THE DA VINCI SYSTEM WAS UNDOCKED FROM THE PATIENT, THE PATIENT SUBSEQUENTLY EXPIRED. ISI DID NOT BECOME AWARE OF THE PATIENT'S DEATH UNTIL THE FOLLOWING DAY WHEN AN ISI FSE VISITED THE SITE TO INSPECT THE DA VINCI SYSTEM. A NURSE AT THE SITE HAD INFORMED THE FSE THAT THE PATIENT DIED AFTER THE DA VINCI SURGICAL PROCEDURE. THE DA VINCI SYSTEM WAS REPAIRED AND VERIFIED TO BE READY FOR USE. ON (B)(6) 2013, THE SURGEON INFORMED AN ISI REPRESENTATIVE THAT THE PATIENT'S DEATH HAD NOTHING TO DO WITH THE DA VINCI SYSTEM BUT THE SURGEON DID NOT PROVIDE ANY FURTHER DETAILS. ON (B)(6) 2013, ISI CLINICAL CONSULTANT SPOKE WITH THE SURGEON INVOLVED WITH THE REPORTED EVENT. THE SURGEON VERIFIED THAT THE PATIENT DIED FOLLOWING A DA VINCI MITRAL

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. EXACT PROCEDURE DATE WAS NOT PROVIDED. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY:SEVERAL TENDONS WERE SEVERED, CAUSED ERECTILE DYSFUNCTIONS.