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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI RADICAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, PELVIC AND PERIAORTIC LYMPHADENECTOMY PROCEDURE ON (B)(6) 2009 FOR STAGE-1 SQUAMOUS CELL CARCINOMA OF THE CERVIX AND ADENOCARCINOMA OF THE ENDOMETRIUM. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED: TWO DISCHARGE SUMMARIES AND THE ENCOUNTER REPORT AT READMISSION. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE ABDOMINAL PART OF THE OPERATION WAS INITIATED WITH CREATING A PNEUMOPERITONEUM USING THE VERESS NEEDLE. DISSECTION OF THE LATERAL LIGAMENTS, MOBILIZATION OF THE OVARIES AND DIVISION OF ARTERIES WAS CARRIED OUT USING CAUTERY INSTRUMENTS. THE UTERUS WAS RESECTED CIRCUMFERENTIALLY WITH ELECTROCAUTERY, THE SPECIMEN REMOVED TRANSVAGINALLY AND THE CUFF CLOSED WITH RUNNING 2-0 VICRYL AND THE LAPRA-TY DEVICE. BILATERAL PELVIC LYMPHADENECTOMY WAS PERFORMED USING ELECTROCAUTERY. FIBRILLARE WAS PLACED IN THE RETROPERITONEAL DISSECTION SPA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S TOTAL HYSTERECTOMY FOR SYMPTOMATIC UTERINE FIBROIDS ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL OPERATIVE AND RADIOLOGY REPORTS THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY]. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. AT THE TIME OF ROBOTIC HYSTERECTOMY THE PATIENT WAS NOTED TO HAVE EXTENSIVE LYSIS OF ADHESIONS ALONG WITH BSO. SHE WAS DISCHARGED HOME IN STABLE CONDITION THE NEXT DAY. ON (B)(6) 2010 THE PATIENT DEVELOPED SOME INCONTINENCE SHE UNDERWENT CYSTOSCOPY WHICH NOTED A FILLING DEFECT AND THEN AFTER WORSENING INCONTINENCE, A VESICOVAGINAL FISTULA WAS DIAGNOSED. ON (B)(6) 2010 UNDERWENT AN OPEN LAPAROTOMY WITH EXCISION OF THE FISTULA AND CLOSURE AND THE APPLICATION OF AN OMENTAL FLAP INTERPOSITION GRAFT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2009 FOR ADENOCARCINOMA OF PROSTATE WITH CLINICAL STAGE T1C AND GLEASON 6. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND FOLLOW UP MEDICAL RECORDS. IN PREPARATION FOR PLANNED DA VINCI PROSTATECTOMY, A DIAGNOSTIC LAPAROSCOPY WITH POSSIBLE LYSIS OF ADHESIONS WAS PERFORMED ON (B)(6) 2009 BECAUSE THERE WERE POSSIBLE ADHESIONS IN THE UPPER ABDOMEN NOTED ABOVE WHERE ALL THE DA VINCI PORTS NEEDED TO BE PLACED. FINDINGS NOTED NO EVIDENCE OF ADHESIONS IN THE AREA NEEDED TO PLACE THE LAPAROSCOPIC PORTS WITH SUPERIORLY LOCATED ADHESIONS NOT MOBILIZED. ACCORDING TO THE DA VINCI OPERATIVE REPORT, THE CORRECT PLANE FOR BLADDER NECK TRANSECTION OF THE POSTERIOR PORTION WAS NOT ENTERED. THE BLADDER NECK WAS TRANSECTED FURTHER BACK BUT BECAUSE OF THE PREVIOUS INCISION THROUGH ALMOST A FULL THICKNESS OF THE PROSTATE DISSECTING ANY MORE POSTERIORLY WAS NOT POSSIBLE. RECTAL ATTACHMENTS WERE DIVIDED, WHICH WAS EXTREMELY DIFFICULT BECAUSE THE RECTUM WAS ADHERENT AND TENTED UP BY THE ATTACHED PROSTATE WITH A SMALL HALF TO 1 CENTIMETER RECTAL OPEN

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI S PROSTATECTOMY PROCEDURE ON (B)(6) 2009 AND ALLEGED TO HAVE INJURIES INCLUDING POSTOPERATIVE TRAUMA AND ABDOMINAL ABSCESS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2009 FOR PROSTATE CANCER. ISI WAS PROVIDED WITH THE OPERATIVE REPORT, CONSULTATION REPORTS FROM (B)(6) 2009 AND (B)(6) 2009, AN ASSISTING VASCULAR SURGEON'S NARRATIVE, AND A SURGICAL PATHOLOGY REPORT. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION - NAMELY PROFUSE BLEEDING FROM THE ILIAC VEIN, RESULTING IN 4L OF BLOOD LOSS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THE PROCEDURE WAS UNREMARKABLE WITH THE EXCEPTION THAT THE PATIENT'S ANATOMY WAS SUCH THAT THE BOWEL WAS CONTINUALLY OBSTRUCTING THE VIEW INTO THE DEEP PELVIS AND THE PATIENT HAD A NARROW PELVIS. THE PROSTATE WAS VERY LARGE AND BROAD AT THE BLADDER BASE. DURING THE VESICOURETHRAL ANASTOMOSIS VISUALIZATION WAS VERY DIFFICULT DUE TO THE DEEP LOCATION OF THE POSTERIOR URETHRA, THE LARGE PUBIC BONE AND PUBIC TUBERCLE. THE BOWEL KEPT INTERFERING AS WELL. DURING THE ANASTOMOSIS, THE EXTERNAL ILIAC VEIN WAS INJURED. THE DA VINCI SYSTEM WAS UNDOCKED AND A MIDLINE INCISION MADE FOR THE REPAIR. VA

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A PLANNED DAVINCI HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, PELVIC WASHINGS, CYSTOSCOPY FOR A PREOPERATIVE DIAGNOSIS OF ENDOMETRIAL HYPERPLASIA WITH ATYPIA AND FIBROID UTERUS ON (B)(6) 2012. IN ADDITION, PATIENT HAD PRIMARY URETERAL REANASTOMOSIS TO REPAIR AN UNINTENTIONAL INTRAOPERATIVE URETERAL TRANSECTION AND BILATERAL PELVIC LYMPHNODE DISSECTION SECONDARY TO AN INTRAOPERATIVE DIAGNOSIS OF ENDOMETRIAL ADENOCARCINOMA. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY PROCEDURE AND THE TWO SUBSEQUENT PROCEDURES. NO MEDICAL HISTORY OR DISCHARGE SUMMARIES WERE PROVIDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THE SURGERY TOOK APPROXIMATELY 11 HOURS. INITIAL DIFFICULTY WAS REPORTED WITH THE FIBROUS 16 WEEK SIZE UTERUS, NECESSITATING PLACEMENT OF THE CAMERA PORT A HANDS BREADTH ABOVE THE UMBILICUS. BLEEDING WAS NOTED UPON ENTRY, AND EXTENSIVE DISSECTION REQUIRED WITH LARGE FIBROID IN THE RIGHT BROAD LIGAMENT CAUSING ANATOMICAL DISTORTION. THE HYSTERECTOMY PORTION WAS CARRIED OUT IN T

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S TOTAL LAPAROSCOPIC HYSTERECTOMY FOR ABNORMAL UTERINE BLEEDING AND FIBROIDS ON (B)(6) 2009. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT (B)(6) 2009. ADDITIONAL INFORMATION PROVIDED INCLUDES HISTORY AND PHYSICAL (H&P) (B)(6) 2009. OUTPATIENT FOLLOW-UP (F/U) NOTE (B)(6) 2009, EMERGENCY DEPARTMENT NOTE (B)(6) 2009 THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE OPERATION WAS INITIATED WITH PLACEMENT OF A RUMI UTERINE MANIPULATOR. PNEUMOPERITONEUM WAS CREATED WITH THE VERESS NEEDLE THROUGH A PREVIOUS LAPAROSCOPIC INCISION. PORTS WERE PLACED AND THE ROBOT WAS DOCKED. USING THE BIPOLAR FORCEPS AND THE MONOPOLAR SCISSORS, THE UTERUS WAS MOBILIZED CIRCUMFERENTIALLY, INCLUDING DISSECTION OF BILATERAL LIGAMENTS; TAKE DOWN OF THE BLADDER FLAP, SKELETONIZATION AND BIPOLAR FULGURATION OF UTERINE ARTERIES. AN ADDITIONAL UTERINE BRANCH IN THE LEFT HEMIPELVIS WAS BLEEDING, WHICH WAS CONTROLLED WITH THE BIPOLAR FORCEPS. COLPOTOMY WAS CARRIED OUT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THREE DAYS AFTER A SUCCESSFUL DA VINCI S HYSTERECTOMY PROCEDURE, THE PT WAS RE-ADMITTED TO THE HOSP WITH A TEMPERATURE AND PERITONITIS SYMPTOMS. TWO DAYS AFTER BEING ADMITTED, A DIAGNOSTIC LAPAROSCOPY PROCEDURE WAS PERFORMED, RESULTING IN THE DISCOVERY OF EIGHT SITES ON THE PT'S SIGMOID COLON NEEDING OVER SEWING. SIX OF THE EIGHT SITES WERE IDENTIFIED AS THERMAL BURNS. NO ADDITIONAL PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI ROBOTIC HYSTERECTOMY WITH BSO AND LYMPHADENECTOMY. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HISTORY AND PHYSICAL, FOLLOW-UP OPERATIVE REPORTS, CONSULTATIONS, RADIOLOGY REPORTS, DISCHARGE SUMMARY, LAB REPORTS, PATHOLOGY REPORTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION NAMELY INJURY TO THE LEFT URETER WHILE TRYING TO EXCISE CANCER. IT WAS REPAIRED AT THE TIME OF THE INITIAL OPERATION. ON (B)(6) 2009 - UNDERWENT ROBOTIC TOTAL HYSTERECTOMY, BSO, PELVIC LYMPHADENECTOMY, PELVIC WASHINGS AND STAGING AND LEFT URETERO-URETERO ANASTOMOSIS WITH STENT PLACEMENT. NOTED SIGNIFICANT ADHESIONS IN SURGERY AND INJURY NOTED AT LEFT URETER DURING PROCEDURE AND REPAIRED THEN. RIGHT URETER NOT DAMAGED. RETURNED TO SURGERY ON (B)(6) 2009 FOR URINE LEAKAGE AND PINPOINT OPENING NOTED LEFT URETER AND SUTURED CLOSED. THE RIGHT URETER WAS OPENED AND A RIGHT URETERAL STENT WAS PLACED. SUBSEQUENTLY SHE DEVELOPED RE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A BJU INTERNATIONAL JOURNAL ARTICLE TITLED, PERIOPERATIVE AND RENAL FUNCTIONAL OUTCOMES OF ELECTIVE ROBOT-ASSISTED PARTIAL NEPHRECTOMY (RAPN) FOR RENAL TUMOURS WITH HIGH SURGICAL COMPLEXITY (VOLPE ET AL., 2014). THE JOURNAL ARTICLE NOTES SEVERAL OPERATIVE COMPLICATIONS. REFER TO MFR. REPORT 2955842-2015-00706 (PATIENT IDENTIFIER (B)(6)) WHICH WAS INITIALLY SUBMITTED TO THE FDA AND BEFORE THE SITE AND SURGEON NAMES RELATED TO THE SURGICAL PROCEDURES WERE KNOWN. ON (B)(4) 2015, A CORRESPONDENCE CONTACT FOR THE JOURNAL ARTICLE PROVIDED THE SITE AND SURGEON NAMES OF THE OPERATIVE COMPLICATIONS NOTED WITHIN THE JOURNAL ARTICLE. IN THE RESULTS SECTION OF THE BJUI JOURNAL ARTICLE, THE FOLLOWING IS STATED: IN ALL, 44 RAPNS FOR RENAL TUMOURS WITH PADUA SCORES OF > 10 WERE INCLUDED IN THE ANALYSIS; 23 TUMOURS (52.3%) WERE CT1B. THE MEDIAN (INTERQUARTILE RANGE; RANGE) OPERATIVE TIME, ESTIMATED BLOOD LOSS AND WARM ISCHAEMIA (WIT) WERE 120 (94, 132; 60-230) MIN, 150 (80, 200; 25- 1200) ML AND 16 (13.8, 18; 5-35) MIN, RESPECTIVELY. TWO INTRAOPERATIVE COMPLICATIONS OCCURRED (4.5%); ONE INFERIOR VENA CAVAL INJURY AND ONE BLEED FROM THE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2010, ISI WAS PRESENTED WITH LEGAL DOCUMENTATION REGARDING THE LITIGATION BETWEEN THE PLAINTIFF AND ELEVEN PARTIES INCLUDING INTUITIVE SURGICAL. THE DOCUMENTATION STATES THAT ON OR ABOUT (B)(6) 2009, THROUGH (B)(6) 2009, A PATIENT WHO UNDERWENT A GYN PROCEDURE AT THE UNIVERSITY HOSPITAL OF (B)(6) WAS SERIOUSLY AND PERMANENTLY INJURED. NO OTHER DETAILS RELATED TO THIS EVENT WERE REPORTED.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A ROBOTIC-ASSISTED LAPAROSCOPIC RADICAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND PELVIC AND PERIAORTIC LYMPH NODE DISSECTION ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. URETEROLYSIS WAS PERFORMED; THE URETERS WERE UNROOFED USING BIPOLAR AND MONOPOLAR ENERGIES. CARE WAS TAKEN NOT TO INJURE THE URETERS. ON (B)(6) 2009, THE PATIENT PRESENTED WITH A SUSPECTED VESICOVAGINAL FISTULA. SHE UNDERWENT AN EXTENSIVE ADHESIOLYSIS, RIGHT URETEROLYSIS AND RIGHT URETERONEOCYSTOSTOMY WITH REPAIR OF VAGINAL FISTULA. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2009. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A CYSTOSCOPY WITH BILATERAL URETERAL TEMPORARY STENT PLACEMENT, DA VINCI RADICAL HYSTERECTOMY WITH RIGHT SALPINGO-OOPHORECTOMY, BILATERAL PELVIC LYMPHADENECTOMY AND LEFT OVARIAN SUSPENSION FOR AN INDICATION OF ADENOCARCINOMA OF THE CERVIX STATUS POST CONIZATION AND RIGHT ADNEXAL MASS PROCEDURE ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT AND TWO SUBSEQUENT PROCEDURE REPORTS. NO MEDICAL HISTORY WAS AVAILABLE. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. BEFORE SURGERY, THE SURGEON PERFORMED A CYSTOSCOPY AND TEMPORARY URETERAL STENT PLACEMENT. DURING SURGERY, THE SURGEON USED HOT SHEARS, FENESTRATED BIPOLAR GRASPER AND A PK DISSECTOR TO FIRST PERFORM A LYMPHADENECTOMY FROM THE COMMON ILIAC ARTERY TO THE CIRCUMFLEX VEIN AND THE OBTURATOR SPACE. THE UTERINE ARTERIES WERE ISOLATED, BIPOLAR CAUTERIZED, DIVIDED AND DISSECTED OVER THE URETERS, AND THE URETERS DISSECTED OFF OF THE MEDIAL PERITONEAL LEAVES, AND THE URETERAL TUNNELS BIPOLAR CAUTERIZED AND OPENED WITH COLD SCISSORS. THE UTEROSA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE ON (B)(6) 2009 FOR PELVIC PAIN AND ENDOMETRIOSIS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT IN ADDITION TO THE SURGICAL PATHOLOGY REPORT AND VARIOUS LAB RESULTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. UPON INITIAL EXAMINATION OF THE PELVIC CONTENTS IMMEDIATELY FOLLOWING ENDOSCOPE PLACEMENT, THE UTERUS APPEARED TO BE ENLARGED AND A DEFECT IN THE RIGHT CORNEAL REGION WAS NOTED, THROUGH WHICH THE BALLOON WAS VISIBLE. SAID DEFECT WAS CONFIRMED IN THE SURGICAL PATH REPORT. MINIMAL BLOOD LOSS OCCURRED DURING THE PROCEDURE, WHICH THE PATIENT TOLERATED WELL AND WAS TAKEN BACK TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. ON (B)(6) 2009, THE PATIENT PRESENTED WITH PELVIC PAIN AFTER INTERCOURSE. A CT SCAN FOUND A SMALL AMOUNT OF PNEUMOPERITONEUM AND NONSPECIFIC FREE FLUID IN THE PELVIS. A CONFLICTING REPORT FROM THE PHYSICIAN STATES THAT ALTHOUGH SHE TOLD THE ER STAFF THAT SHE HAD INTERCOURSE, IT WAS NOT TRUE. A VAGINAL EVALUATION WAS PERFORMED AND THE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC. (ISI)RECEIVED INFORMATION OF A PATIENT WHO UNDERWENT A DA VINCI PROSTATECTOMY ON 05/01/2009 AND SUFFERED INJURIES AND DAMAGES. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI TOTAL HYSTERECTOMY FOR MENORRHAGIA AND DYSMENORRHEA PROCEDURE ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY SURGERY AND SECONDARY REVISION SURGERY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. AFTER PORT PLACEMENT, THE ROUND LIGAMENTS, UTEROOVARIAN VASCULAR PEDICLES COAGULATED AND DIVIDED. THE BLADDER FLAP WAS CREATED, THE UTERINE ARTERIES COAGULATED AND DIVIDED AND THE COLPOTOMY PERFORMED OVER THE VCARE CUP. THE UTERUS WAS DELIVERED THROUGH THE VAGINA, SMALL BLEEDERS CONTROLLED ON THE VAGINAL CUFF WITH CAUTERY, AND THE VAGINAL CUFF CLOSED WITH POLYSORB AND A LAPRA-TY. A SHEET OF INTERCEED WAS PLACED OVER THE VAGINAL CUFF, AND THE PROCEDURE COMPLETED WITHOUT COMPLICATION. ON (B)(6) 2009, ON A POSTOPERATIVE VISIT PATIENT WAS DOING WELL WITH NO TENDERNESS, AND A WELL HEALED INCISION CITE. ON (B)(6) 2009, PATIENT PRESENTED WITH HISTORY OF PAIN WITH INTERCOURSE SINCE (B)(6) 2009. VAGINAL EXAM SHOWED ABSENT CERVIX, HEALED VAGINAL CUFF, ADNEXAL TENDERNESS. AN U/S

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S PROSTATECTOMY PROCEDURE (B)(6) 2009. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED AN INJURY TO HIS OBTURATOR NERVE AND REQUIRED 4 UNITS OF BLOOD. ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT WAS HOSPITALIZED FOR 21 DAYS. REPORTEDLY, POST-OPERATIVELY THE PATIENT IS IMPOTENT AND INCONTINENT. NO OTHER INFORMATION REGARDING THE REPORTED EVENT WAS PROVIDED.

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING A MEDICAL RECORD REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2009. THE OPERATIVE REPORT FOR THE DA VINCI PROSTATECTOMY PROCEDURE WAS NOT PROVIDED; HOWEVER, AN OPERATIVE REPORT FOR THE REPAIR OF ENTEROTOMY AND SMALL BOWEL RESECTION WAS PROVIDED. ACCORDING TO THE PROVIDED OPERATIVE REPORT, THE SURGEON PERFORMING THE DA VINCI PROSTATECTOMY CONSULTED WITH ANOTHER SURGEON DURING THE PROSTATECTOMY DUE TO AN INTRA-OPERATIVE INJURY TO THE PATIENT'S SMALL BOWEL. IT WAS NOTED THAT THE PATIENT SUSTAINED THE SMALL BOWEL INJURY (ENTEROTOMY X2) DUE TO SEVERE ADHESIONS OF THE PELVIS FROM PREVIOUS TRANSABDOMINAL SURGERY. THE PATIENT RECEIVED A SMALL BOWEL RESECTION OF MID TO DISTAL ILEUM, ABOUT A 12 CM SEGMENT, WITH PRIMARY ANASTOMOSIS. THE PATIENT TOLERATED THE SMALL BOWEL REPAIR WELL AND THE REMAINDER OF THE PROSTATECTOMY WAS LEFT UNDER THE CARE OF THE INITIAL DA VINCI SURGEON. THERE WAS NO SPECIFIC ALLEGATION OF ANY MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY IN THE PROVIDED DOCUMENT. NO OTHER INFORMATION WAS PROVIDED. SINCE THE DA VINCI PROSTATECTOMY OPERATIVE REPORT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A JOURNAL ARTICLE BY COOPER ET AL TITLED, UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS. IN THIS ARTICLE, THE AUTHORS REPORTED COMPLICATIONS REPORTED IN MAUDE DATABASE OR LEXISNEXIS, AND PACER (PUBLIC ACCESS TO COURT ELECTRONIC RECORDS) FROM JANUARY 1, 2000 TO AUGUST 1, 2012. ACCORDING TO A REPORTED INJURY IN THE ARTICLE, A FAILURE OF BAND AND CLIP DURING A PATIENT'S DA VINCI MITRAL VALVE REPAIR PROCEDURE ON (B)(6) 2009 LED TO THE PATIENT'S CONGESTIVE HEART FAILURE AND SUBSEQUENT OPEN HEART REPAIR. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT. THE HOSPITAL NAME, PATIENT INFORMATION, AND DA VINCI SYSTEM SERIAL INVOLVED WITH THIS COMPLAINT WERE NOT INCLUDED IN THE ARTICLE. ARTICLE INFORMATION: TITLE: UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS AUTHORS: MICHOL A. COOPER, ANDREW IBRAHIM, HEATHER LYU, MARTIN A. MAKARY PUBLISHED DATE: 08/27/2013 LINK: (B)(4).

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S SACRAL COLPOPEXY FOR TOTAL VAGINAL PROLAPSE ON (B)(6) 2009. THE PROCEDURE WAS CONVERTED TO AN OPEN SACRAL COLPOPEXY. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: ADMISSION NOTES, POST-OP NOTES, DISCHARGE SUMMARY, UROLOGY CLINIC NOTES (B)(6) 2009 PRIOR TO THE PROCEDURE, THE RISKS AND BENEFITS OF SURGERY WERE DISCUSSED WITH THE PATIENT. THE PATIENT CHOSE TO UNDERGO A ROBOT-ASSISTED LAPAROSCOPIC SACRAL COLPOPEXY. THERE WAS INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION. PNEUMOPERITONEUM WAS ACHIEVED USING A DIRECT VISION TROCAR IN THE MIDLINE WITHOUT DIFFICULTY. THE CAMERA WAS THEN PLACED AND NO SIGNS OF A BOWEL INJURY WERE OBSERVED. FOUR OTHER PORTS WERE THEN PLACED AND THE TROCARS WERE PLACED UNDER DIRECT VISION AND LAPAROSCOPICALLY. THE ADHESIONS WERE TAKEN DOWN. THE ROBOT WAS THEN DOCKED. DURING TAKE DOWN OF DENSE ADHESIONS IN THE BOWEL AREA, A SMALL HOLE WAS MADE IN THE BLADDER. THE HOLE WAS SUTURE CLOSED U

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT WITH THE FOLLOWING ALLEGATION: IT WAS REPORTED THAT AFTER A DA VINCI SI NEPHRECTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2009, BLEEDING WAS NOTED FROM THE PATIENT'S AORTA. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

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 09/04/2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A JOURNAL ARTICLE BY COOPER ET AL TITLED, UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS. IN THIS ARTICLE, THE AUTHORS REPORTED COMPLICATIONS REPORTED IN MAUDE DATABASE OR LEXISNEXIS, AND PACER (PUBLIC ACCESS TO COURT ELECTRONIC RECORDS) FROM JANUARY 1, 2000 TO AUGUST 1, 2012. ACCORDING TO A REPORTED INJURY IN THE ARTICLE, A PATIENT SUSTAINED A PERFORATED VISCOUS INJURY AND REQUIRED MULTIPLE SUBSEQUENT SURGERIES AFTER UNDERGOING A DA VINCI LEFT SALPINGO OOPHORECTOMY PROCEDURE ON (B)(6) 2009 . NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT. THE HOSPITAL NAME, PATIENT INFORMATION, AND DA VINCI SYSTEM SERIAL INVOLVED WITH THIS COMPLAINT WERE NOT INCLUDED IN THE ARTICLE. ARTICLE INFORMATION: TITLE: UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS AUTHORS: MICHOL A. COOPER, ANDREW IBRAHIM, HEATHER LYU, MARTIN A. MAKARY PUBLISHED DATE: 08/27/2013 LINK: HTTP://ONLINELIBRARY.WILEY.COM/DOI/10.1111/JHQ.12036/ABSTRACT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI VAGINAL VAULT REPAIR ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. MULTIPLE PRE-OP AND POST-OP REPORTS ARE INCLUDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION - NAMELY A TEAR OF THE INFERIOR VENA CAVA. UPON ENTERING THE ABDOMEN EXTENSIVE ADHESIONS WERE NOTED AND ONE HOUR WAS SPENT LYSING THEM PRIOR TO THE ROBOTIC INSTRUMENTS BEING PLACED. ALL WERE RELEASED EXCEPT FOR ONE, WHICH WAS HERNIATED THROUGH A PREVIOUS INCISION SITE. FURTHER ENTEROLYSIS WAS PERFORMED AFTER THE ROBOT WAS DOCKED. THE LOOP OF SMALL BOWEL THAT WAS ATTACHED THROUGH THE ANTERIOR ABDOMINAL WALL HERNIATION SITE WAS RELEASED USING THE ROBOT. THE SMALL BOWEL WHICH WAS INVOLVED IN THIS PART WAS EXAMINED AND THE SEROSA NOTED TO BE SOMEWHAT DENUDED. THIS AREA IS OVERSEWN WITH SUTURE. SHORTLY AFTER THE SACRAL PROMONTORY WAS IDENTIFIED AND EXPOSED BLEEDING WAS NOTED FROM THE INFERIOR PORTION OF THE VENA CAVA. VASCULAR SURGEONS WERE BROUGHT IN AND CLIPS WERE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A JOURNAL ARTICLE BY COOPER ET AL TITLED, UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS. IN THIS ARTICLE, THE AUTHORS REPORTED COMPLICATIONS REPORTED IN MAUDE DATABASE OR LEXISNEXIS, AND PACER (PUBLIC ACCESS TO COURT ELECTRONIC RECORDS) FROM JANUARY 1, 2000 TO AUGUST 1, 2012. ACCORDING TO A REPORTED INJURY THE ARTICLE, A PATIENT SUSTAINED A URETERAL INJURY AND RENAL INSUFFICIENCY AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2009. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT. THE HOSPITAL NAME AND DA VINCI SYSTEM SERIAL INVOLVED WITH THIS COMPLAINT WERE NOT INCLUDED IN THE ARTICLE. ARTICLE INFORMATION: TITLE: UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS AUTHORS: MICHOL A. COOPER, ANDREW IBRAHIM, HEATHER LYU, MARTIN A. MAKARY PUBLISHED DATE: 08/27/2013 LINK: (B)(6).

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI S PROSTATECTOMY PROCEDURE, THE PATIENT DEVELOPED BILATERAL LEG NERVE PALSY. NO ADDITIONAL PATIENT HARM OR ADVERSE OUTCOME WAS REPORTED.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2009. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND/OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, ON JULY 25TH, 2013 INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2009. THE PATIENT'S MEDICAL HISTORY SUMMARY WAS PROVIDED. THE INFORMATION RECEIVED STATED THAT DURING THE SURGICAL PROCEDURE, A FAILURE OF THE THREE-DIMENSIONAL OPTICAL SYSTEM OCCURRED WHILE THE SURGEON WAS SUTURING THE VAGINAL CUFF AND THE PATIENT SUSTAINED A VAGINAL CUFF DEHISCENCE. THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT UNDERWENT THE DA VINCI SI HYSTERECTOMY ON (B)(6) 2009 FOR CHRONIC ABDOMINAL PAIN, CHRONIC MENOMETRORRHAGIA, CHRONIC PELVIC PAIN, DYSMENORRHEA, AND SYMPTOMATIC LEIOMYOMA. THE MEDICAL SUMMARY INDICATES THAT EQUIPMENT FAILURE OCCURRED PRESUMED DIGITIZER ON THE LEFT 3D EYE SYSTEM ON THE CONSOLE AT THE POINT OF SUTURING. BOTH 2D AND 3D VISUAL SYSTEMS WERE THEN UTILIZED TO COMPLETE THE CASE IN A VERY SAFE MANNER WITHOUT COMPLICATIONS TO THE PATIENT. THE PATIENT EXPERIENCED POST-OPERATIVE NAUSEA FOR 2 DAYS BEFORE SHE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2009. THE PATIENT INDICATED THAT SHE WAS SENSITIVE TO NARCOTIC MEDICATIONS AND THAT T

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 ENDOSCOPE TIP BECAME VERY HOT AND BURNT THE PATIENT'S BOWEL. SURGICAL INTERVENTION WAS NOT REQUIRED, AND THE PLANNED PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI S PROSTATECTOMY PROCEDURE ON (B)(6) 2009. THE DOCUMENTATION PROVIDED STATES THAT THE PATIENT DEVELOPED AN ABSCESS AS A RESULT OF UNDERGOING THE SURGICAL PROCEDURE AND WAS HOSPITALIZED. THE PATIENT'S OPERATIVE REPORT FOR (B)(6) 2009, INDICATED THAT HE UNDERWENT A RADICAL PROSTATECTOMY, FOLLOWED BY A BILATERAL PELVIC LYMPH NODE DISSECTION. THE PATIENT HAD BEEN DIAGNOSED WITH ADENOCARCINOMA OF THE PROSTATE. NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED ON THE OPERATIVE REPORT. THE OPERATIVE REPORT ALSO NOTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY ON (B)(6) 2009, AND WAS REPORTED TO BE DOING FINE. THE DISCHARGE SUMMARY INDICATED THAT THE PATIENT WAS AFEBRILE, HIS URINE WAS CLEAR, WITH MINIMAL DRAINAGE. HE WAS DISCHARGED WITH A FOLEY CATHETER. ON (B)(6) 2009, THE PATIENT HAD A POST-OPERATIVE FOLLOW-UP APPOINTMENT WITH THE SURGEON. THE PATIENT'S CATHETER WAS REMOVED. THE PATIENT'S PORT SITES LOOKED GOOD. DURING A FOLLOW UP VISIT ON (B)(6) 2009 THE PATIENT 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: PER LEGAL SUMMONS RECEIVED ON (B)(4) 2012, IT WAS ALLEGED THAT THE PATIENT HAD A DA VINCI S HYSTERECTOMY SURGERY ON (B)(6) 2009 TO REMOVE OVARIAN FIBROID TUMORS. FIVE WEEKS AFTER SURGERY, THE PATIENT BEGAN FEELING FEVERISH AND NAUSEOUS AND HAD DIARRHEA. IT WAS ALLEGED THE PATIENT HAD NOT ENGAGED IN SEXUAL INTERCOURSE SINCE THE SURGERY. AT THAT TIME, IT WAS ALLEGED THE PATIENT ENGAGED IN SEXUAL INTERCOURSE WITH HER HUSBAND AND EXPERIENCED LIGHT BLEEDING. WHEN THE PATIENT USED THE BATHROOM THEREAFTER, THE PATIENT HEARD A POP AND ALLEGEDLY SAW APPROXIMATELY AN INCH OF INTESTINES COMING OUT OF HER VAGINA. THE PATIENT WAS ADMITTED AT THAT TIME TO (B)(6). A DIFFERENT SURGEON PERFORMED EMERGENCY OPEN LAPAROTOMY SURGERY. WHILE OPERATING, A MASSIVE INFECTION WITH CYSTS AND ADHESIONS ENCAPSULATING THE FALLOPIAN TUBE AND OVARY WAS FOUND AND THE RIGHT OVARY HAD TO BE REMOVED AS A RESULT. ADDITIONALLY, THE INFECTION DETERIORATED THE VAGINAL CUFF TISSUE THAT HAD BEEN SEWN DURING THE DA VINCI S HYSTERECTOMY CAUSING THE CUFF TO TEAR LEADING TO A SMALL BOWEL EVISCERATION. THE INFECTED TISSUE WAS REMOVED AND VAGINAL CUFF RE-SEWN. THE PATIENT STAYED IN THE HOSPITAL FIVE DAYS.

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 WAS TOLD BY THE SURGEON THAT I HAD PROSTATE CANCER AND HE SUGGESTED THE DA VINCI ROBOT. HE SAID THAT I WOULD NOT EVEN KNOW THAT I HAD BEEN OPERATED ON AND THAT I WOULD LEAVE THE HOSPITAL THE NEXT DAY. HOWEVER, I REMAINED A PT IN THE HOSPITAL FOR 33 DAYS, I WAS BLEEDING INTERNALLY AND I WAS GIVEN 18 PINTS OF BLOOD. I LOST OVER 45 LBS AND I COULD NOT WALK, EAT, OR DRINK ANYTHING BY MYSELF. I WAS FINALLY RELEASED AFTER 33 DAYS IN THE HOSPITAL AND 12 HOURS AFTER I WAS DISCHARGED, I HAD TO BE READMITTED BECAUSE OF PAIN, BLEEDING AND NAUSEA. SINCE THE DA VINCI SURGERY, I HAVE HAD TO HAVE SEVEN MORE OPERATIONS. THE SURGEON THAT PERFORMED THE ORIGINAL DA VINCI ROBOTIC SURGERY NEVER EVER CAME TO SEE ME OR TO CHECK ON ME WHILE I WAS HOSPITALIZED FOR APPROX 5 WEEKS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI ROBOTIC SACROCOLPOPEXY FOR VAGINAL PROLAPSE ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2009, THE PATIENT UNDERWENT ROBOTIC SACROCOLPOPEXY, LYSIS OF ADHESIONS AND SLING PROCEDURE WITH CYSTOSCOPY. DURING PROCEDURE IT WAS NOTED THAT THERE WAS MULTIPLE ADHESIONS AND A GENERAL SURGEON CAME AND TOOK DOWN ADHESIONS. IN RECOVERY, THE PATIENT DEVELOPED SEVERE HYPOTENSION, HAD LARGE BLOODY EMESIS AND WAS FOUND TO HAVE AN ACTIVELY BLEEDING STOMACH ULCERATION. THE PATIENT DEVELOPED ACUTE TUBULAR NECROSIS (ATN), HAD A COAGULOPATHY, BECAME SEPTIC, BUT ULTIMATELY WAS TREATED AND STABILIZED IN ICU. ON (B)(6) 2009, ADDITIONALLY THE PATIENT UNDERWENT A RIGHT HEMICOLECTOMY FOR ISCHEMIC BOWEL INJURY. THE PATIENT WAS DISCHARGED ON (B)(6) 2009. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING BRIEF MEDICAL RECORDS,OF A PATIENT WHO UNDERWENT A ROBOTIC HYSTERECTOMY ON (B)(6) 2009. PER MEDICAL RECORDS THE PATIENT TOLERATED THE SURGICAL PROCEDURE WELL AND WAS DISCHARGED THE FOLLOWING DAY, (B)(6) 2009. ON (B)(6) 2009, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT A VAGINAL CUFF REPAIR ON (B)(6) 2009. PER DISMISSAL SUMMARY HER POSTOPERATIVE COURSE WAS UNCOMPLICATED. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2009. PER BRIEF DISCHARGE SUMMARY, THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2009 DUE TO VAGINAL BLEEDING. SHE UNDERWENT EXAMINATION UNDER ANESTHESIA AND CYSTOSCOPY. AS EXAM REVEALED VAGINAL CUFF ABSCESS, NO VAGINAL CUFF DEHISCENCE. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS, AND SHE WAS THEN DISMISSED HOME WITH ORAL ANTIBIOTICS. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE PATIENT'S CURRENT STATUS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON (B)(6) 2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2009 FOR SYMPTOMATIC FIBROID UTERUS. ACCORDING TO THE OPERATIVE REPORTS, THE SURGEON EVALUATED THE PATIENT'S PELVIS DURING THE DA VINCI SURGICAL PROCEDURE AND INDICATED THERE WAS A MARKEDLY ENLARGED MULTI-FIBROID UTERUS. AFTER THE VAGINAL CUFF WAS CLOSED, THE SURGEON NOTED A SMALL AMOUNT OF WELLING OF METHYLENE BLUE FROM THE LEFT PELVIC BRIM. THE SURGEON SUSPECTED A BLADDER OR URETHRAL INJURY AND UROLOGY WAS CONSULTED. WHEN UROLOGY ARRIVED, A CYSTOSCOPY WITH RETROGRADE PLACEMENT OF A GUIDEWIRE WAS PERFORMED AND REVEALED THERE WAS A LEFT URETERAL TRANSECTION CLOSE TO THE BLADDER NECK. THE FOLEY CATHETER WAS REPLACED IN THE URINARY BLADDER AND THE PATIENT WAS THEN UNDOCKED FROM THE DA VINCI SYSTEM. THE UROLOGIST EXAMINED THE PATIENT'S PELVIS THROUGH A SMALL AMOUNT OF DISSECTION IN THE CAMPER'S FASCIA. THE SMALL AMOUNT OF DISSECTION REVEALED THE TRANSECTED LEFT URETER AND CHARRING WAS OBSERVED AT THE END OF THE URETER. THE UROLOGIST REPAIRED THE URETERAL INJURY BY DIRECTLY IMPLANTING TH

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 TOTAL BENIGN HYSTERECTOMY PROCEDURE IN 2009. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT DA VINCI S SACROCOLPOPEXY PROCEDURE FOR VAGINAL PROLAPSE AND STRESS INCONTINENCE ON (B)(6) 2008. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP OPERATIVE REPORTS AND CONSULTATIONS. ON (B)(6) 2008 THE PATIENT UNDERWENT ROBOTIC LAPAROSCOPIC SACROCOLPOPEXY AND LYSIS OF ADHESIONS AND LEFT OVARIAN CYSTECTOMY WITH TRANSVAGINAL TAPE AND CYSTOSCOPY. PROCEDURE TOOK SEVEN HOURS TO COMPLETE (LARGER BMI). THE PATIENT DEVELOPED PLEURAL EFFUSIONS AND EDEMA OF HEAD AND NECK POST OP. THE PATIENT WAS IN ICU ON VENTILATOR FOR SEVERAL DAYS AND WAS DISCHARGED HOME ON (B)(6) 2009. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2009, THE PATIENT PRESENTED WITH RECTOVAGINAL FISTULA. THE PATIENT UNDERWENT DIVERTING LOOP COLOSTOMY (SIGMOID) ON (B)(6) 2009. ON (B)(6) 2009, THE PATIENT WAS ADMITTED FOR EXCISION OF RECTOVAGINAL FISTULA WITH END COLOSTOMY AS PROBLEMS PERSISTED, SOME AS A RESULT OF ROBOTIC SURGERY AND S

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC., (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS AND OPERATIVE REPORTS OF A PATIENT WHO UNDERWENT A ROBOTIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, PELVIC AND PERIAORTIC LYMPHADENECTOMY AND SUFFERED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL PROCEDURE ON (B)(6) 2008. BASED ON THE OPERATIVE REPORTS,THE DA VINCI PROCEDURE WAS WELL TOLERATED BY THE PATIENT AND THERE WAS NO MALFUNCTION THAT OCCURRED WITH THE DA VINCI SYSTEM AND OR INSTRUMENTS. POSTOPERATIVELY, THE PATIENT WAS NOTED TO HAVE ABDOMINAL DISTENTION AND NAUSEA AND WAS KEPT IN THE HOSPITAL AN EXTRA NIGHT AND WAS DISCHARGED ON (B)(6) 2008. ON (B)(6) 2008, THE PATIENT WAS SEEN IN THE ER FOR ABDOMINAL PAIN. CT SCAN SHOWED SMALL AMOUNT OF FLUID IN THE PELVIS WITH NO SIGNS OF PERITONITIS. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND WAS SENT HOME AFTER ABOUT 4 DAYS OF HOSPITALIZATION. SHE RETURNED TO THE HOSPITAL ON (B)(6) 2009 WITH WORSENING SYMPTOMS AND A CT SCAN WAS PERFORMED. THE CT SCAN SHOWED DILATED LOOPS OF SMALL BOWEL WITH AIR FLUID LEVELS AND SOME PELVIC FLUID. ON (B)(6) 2009, THE PATIENT WENT INTO THE OPERATING ROOM FOR 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: AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC., (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS AND OPERATIVE REPORT OF A PATIENT WHO SUFFERED POST- SURGICAL COMPLICATIONS AFTER UNDERGOING A RIGHT HEMI COLECTOMY WITH RIGHT ILEAL REVISION DA VINCI SURGICAL PROCEDURE. THE PATIENT WAS REFERRED TO GENERAL SURGERY CLINIC AFTER SHE WAS FOUND TO HAVE A LONG ILEAL SEGMENT OF CROHN'S AND WORSENING ABDOMINAL PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL. AFTER EXPLAINING THE RISK AND BENEFITS OF THE PROCEDURE INCLUDING RISK OF INTERNAL HERNIA, BLEEDING, LEAK, RECURRENCE, NEED FOR REOPERATION THE PATIENT CONTINUED TO UNDERGO A DA VINCI RIGHT HEMICOLECTOMY WITH EXTENDED RIGHT ILEAL RESECTION WITH TWO- LAYER HAND SEWN ANASTOMOSIS ON (B)(6) 2012. IN THE OPERATIVE REPORT THERE IS NO EVIDENCE THAT THE DA VINCI SYSTEM OR INSTRUMENT MALFUNCTIONED. THE CROHN'S DISEASE RESECTION TOOK PLACE AT MID BOWEL LEVEL, ANASTOMOSIS WAS CREATED USING STAPLES WHICH DID NOT SHOW ANY EVIDENCE OF BLEEDING. THE MESENTERIC DEFECTS WERE CLOSED USING RUNNING 2.0 SILK AND THE ABDOMEN WAS WELL IRRIGATED. THERE WAS NO EVIDENCE OF FRANK PUS AND ALL DISSECTED AREAS WERE FOUND TO BE HEMOSTATIC. 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: AFTER A DA VINCI HYSTERECTOMY PROCEDURE, DURING THE CYSTOSCOPY, IT WAS FOUND THAT THE PATIENT'S URETER HAD BEEN DAMAGED. THE URETER WAS REPAIRED VIA A URETERONEOCYSTOTOMY PROCEDURE, AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. NO ADDITIONAL PATIENT HARM OR ADVERSE OUTCOME WAS REPORTED.