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 PROCEDURE. TYPE OF PROCEDURE IS UNKNOWN. PATIENT UNDERWENT A DA VINCI PROCEDURE ON (B)(6) 2011. 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: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2011, AND ALLEGED TO HAVE INJURIES INCLUDING A PERFORATED COLON AND INFECTION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2011, AND ALLEGED TO HAVE INJURIES INCLUDING URETER INJURIES AND POSTOPERATIVE TRAUMA. 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: AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2011 AND WAS FOUND TO HAVE A URETER INJURY 14 DAYS LATER. NOTE THAT ALL OF THE INFORMATION RECEIVED IS THE PATIENT'S STATEMENT AND NO MEDICAL RECORDS WERE PROVIDED. THE PATIENT WAS DIAGNOSED WITH UTERINE FIBROIDS, HEAVY MENSTRUAL BLEEDING, AND PELVIC PAIN. THE DA VINCI SI HYSTERECTOMY PROCEDURE WAS COMPLETED AS PLANNED AND THE PATIENT DESCRIBED HER RECOVERY FROM THE PROCEDURE AS BETTER THAN EXPECTED. ON (B)(6) 2011 THE PATIENT EXPERIENCED A CONSTANT FLOW OF URINE THAT LEAKED FROM HER VAGINA UNCONTROLLABLY AND AT ALL TIMES. THIS WAS STATED BY THE PATIENT TO BE DUE TO A THERMAL BURN SUSTAINED ON THE LOWER PORTION OF THE PATIENT'S RIGHT URETER. THE BURN WAS ALLEGED TO HAVE CREATED A UTEROVAGINAL FISTULA AS DIAGNOSED BY THE OPERATING SURGEON. THE PATIENT STATES THAT SHE REQUIRED THREE ADDITIONAL HOSPITALIZATIONS WITH THREE ADDITIONAL UNSPECIFIED SURGERIES DURING A SIX MONTH COURSE OF TREATMENT. HER TREATMENT INCLUDED THE PLACEMENT AND REPLACEMENT OF LONG URETERAL STENTS WHICH CAUSED HER PHYSICAL DISCOM

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) 2012 A PATIENT POSTED THE FOLLOWING INFORMATION ON (B)(4): THE PATIENT INDICATED THAT ON (B)(6) 2012 THAT SHE UNDERWENT AN EXPLORATORY EXAMINATION BY DR (B)(6) USING THE DA VINCI SI SURGICAL SYSTEM DUE TO A OVARIAN CYST THAT BURST. THE PATIENT REPORTED THAT SHE WAS TO UNDERGO A DA VINCI SURGICAL PROCEDURE TO REMOVE THE CYST, HOWEVER, 3 DAYS PRIOR TO THE PLANNED SURGICAL PROCEDURE, THE CYST BURST. POST OPERATIVELY THE PATIENT EXPERIENCED PAIN AND WAS TOLD BY THE ATTENDING NURSE THAT DR (B)(6) PERFORMED AN APPENDECTOMY (DUE TO ENDOMETRIOSIS AND CHRONIC APPENDICITIS) AND A CYSTECTOMY. REPORTEDLY THE PATIENT WAS NOT AWARE THAT SHE HAD ANY OTHER CYSTS EXCEPT FOR THE CYST THAT RESOLVED ITSELF. THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC, NAUSEA SUPPOSITORIES AND PAIN MEDICATIONS AND RELEASED FROM THE HOSPITAL ON (B)(6) 2011. THE PATIENT INDICATED THAT SHE EXPERIENCED EXTREME NAUSEA AND VOMITING 2 DAYS POST OP AND ON (B)(6) 2011, SHE CONTACTED DR (B)(6) HOWEVER, DR (B)(6) WAS NOT AVAILABLE. THE PATIENT INDICATED THAT ON (B)(6) 2011 WENT TO THE (B)(6) EMERGENCY ROOM AND IT WAS DISCOVERED THAT THE PATIENT WAS SEPTIC AND WAS LOOSING BLOOD. THE PATIENT INDICATED THAT ON (B)(6) 2011 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, ON JULY 25, 2013 INTUITIVE SURGICAL, INC. RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY WITH DIAGNOSTIC CYSTOSCOPY ON (B)(6) 2011. THE PATIENT DEVELOPED POST -SURGICAL COMPLICATIONS ON (B)(6) 2012, THE PATIENT RETURNED TO THE OPERATING ROOM FOR AN ACUTE RIGHT ADNEXAL PAIN WITH A PELVIC MASS. A DIAGNOSTIC LAPAROSCOPY, RIGHT SALPINGO-OOPHORECTOMY, AND LYSIS OF ADHESIONS WERE PERFORMED FOR A HEMORRHAGIC RIGHT OVARIAN CYST AND ADHESIONS. THE SURGEON DESCRIBED MILD ADHESIONS OF THE BOWEL TO THE VAGINAL CUFF THAT AND SOME HEMORRHAGIC AREAS ON BOTH SIDES OF THE VAGINAL CUFF THAT WERE BIOPSIED. THE PATIENT'S SURGICAL PATHOLOGY REPORT WAS NOT AVAILABLE FOR REVIEW. ON (B)(6) 2012 THE PATIENT VISITED THE EMERGENCY ROOM WITH REPORTS OF SEVERAL HOURS OF ACUTE ONSET OF ABDOMINAL PAIN THAT OCCURRED DURING SEXUAL INTERCOURSE. A CT SCAN SHOWED AREAS OF PNEUMOPERITONEUM WITH FLUID IN THE PELVIS. THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY WITH DRAINAGE OF A PELVIC ABSCESS. IT WAS NOTED IN THE DIAGNOSTIC LAPAROSCOPY THAT THE RIGHT SIDE OF THE VAGINAL CUFF WAS FOUND TO BE OPEN WITH THE SMALL BOWEL PROTRUDIN

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 25, 2013, INTUITIVE SURGICAL RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI SI RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2011. THE PATIENT'S OPERATIVE NOTES STATE THAT DURING THE DA VINCI SI RADICAL PROSTATECTOMY PROCEDURE THE SURGEON ENCOUNTERED BLEEDING OF THE DORSAL VEIN COMPLEX, WHICH WAS CAUTERIZED. HOWEVER THE VEIN COMPLEX STARTED TO BLEED AGAIN. THE INSTRUMENT WAS CHANGED TO A CLIP APPLIER HOWEVER ACCESS TO THE PORT WAS LOST. THE DA VINCI SI SYSTEM WAS UNDOCKED, AND ALL PORTS WERE REMOVED AND THE PROCEDURE WAS CONVERTED A LAPAROTOMY PROCEDURE. THE PATIENT WAS REPORTED TO BE STABLE WHEN TRANSFERRED TO THE RECOVERY ROOM. DURING A FOLLOW UP VISIT WHILE THE PATIENT WAS IN RECOVERY, HE WAS NOTED TO HAVE SOME RESPIRATORY DISTRESS AND WAS TRANSFERRED TO ICU. SHORTLY AFTER THE PATIENT STABILIZED AND WAS RETURNED BACK TO THE GENERAL HOSPITAL FLOOR. HE WAS DISCHARGED HOME ON (B)(6) 2011. THE DISCHARGE SUMMARY PROVIDED STATES THAT THE PATIENT TOLERATED THE PROCEDURE WELL WITH MINIMAL COMPLICATIONS. THE PATIENT REPORTED DIFFICULTY URINATING AND ON (B)(6) 2012 THE PATIENT HAD A CYSTOSCOPY WHICH SHOWED A V

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 RADICAL HYSTERECTOMY WITH BILATERAL PELVIC LYMPHADENECTOMY FOR STAGE 1B SQUAMOUS CELL CARCINOMA OF THE CERVIX ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY SURGERY, PREOPERATIVE H&P, SEVERAL CT RECORDS, PROCEDURE RECORDS, AND THE DISCHARGE SUMMARY FOR THE LAST SURGERY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE UTERUS WAS NOTED TO BE SMALL AND MOBILE. THE PERIRECTAL AND PERIVESICAL SPACES AND BLADDER FLAP WERE DEVELOPED WITH NO EVIDENCE OF DISEASE, AND NODAL DISSECTIONS WERE COMPLETED FROM THE BIFURCATIONS OF THE COMMON ILIAC ARTERIES TO THE CIRCUMFLEX VEIN AND FROM THE OBTURATOR SPACES. THE UTERINE ARTERIES WERE CAUTERIZED AND DIVIDED AND URETERS WERE DISSECTED OFF OF THE MEDIAL ASPECT OF THE PERITONEUM TO THE LEVEL OF THE BLADDER WITH BLUNT DISSECTION AND ELECTROCAUTERY WITH CARE TO PRESERVE THE BLOOD SUPPLY. THE UTEROSACRAL, AND CARDINAL LIGAMENTS WERE DIVIDED, THE VAGINA CIRCUMFERENTIALLY DIVIDED, AND THE UTERUS DELIVERED THROUGH THE VAGINA. OBTUR

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 RECEIVED INFORMATION, INCLUDING OPERATIVE REPORT OF A PATIENT WHO UNDERWENT A DA VINCI LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2011. THIS LEGAL ALLEGATION INDICATES THAT THE PATIENT SUFFERED POST-OPERATIVE COMPLICATIONS AFTER A DA VINCI HYSTERECTOMY PROCEDURE. THE PATIENT UNDERWENT A DA VINCI PROCEDURE ON (B)(6) 2011 AND IT WAS NOTED IN THE OPERATIVE REPORT THAT THE PROCEDURE WAS UNEVENTFUL. THE PATIENT EXPERIENCED PAIN DURING POSTOPERATIVE COURSE WHICH WAS WELL CONTROLLED BY POST-OPERATIVE DAY 2. THE PATIENT WAS DISCHARGED ON (B)(6) 2011 (TWO DAYS AFTER SURGERY) IN A STABLE CONDITION. THERE IS NO INDICATION THAT THE DA VINCI SYSTEM, INSTRUMENT OR ACCESSORIES MALFUNCTIONED BASED ON THE OPERATIVE REPORT. AS PER THE MEDICAL RECORDS, THE PATIENT DEVELOPED LEFT LOWER QUADRANT AND LEFT FLANK PAIN, VAGINAL LEAKAGE AND URINARY INCONTINENCE TWO WEEKS POST-OPERATIVELY AND WAS ADMITTED AND EVALUATED ON (B)(6) 2011. A CT UROGRAM ON (B)(6) 2011 SHOWED A LEFT DISTAL URETERAL INJURY AND A URETEROVAGINAL FISTULA. THE PATIENT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2012 FOR FURTHER EVALUATION AND A CYSTOSCOPY SHOWED NO EVIDENCE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PIECE OF THE WORKING ELEMENT ON A PERMANENT CAUTERY SPATULA BEING USED IN THE O.R. BROKE OFF INSIDE THE ABDOMEN DURING A PROCEDURE. PIECE WAS VISUALIZED AND REMOVED. CASE CONTINUED WITH A NEW DEVICE.

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 25, 2013 INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2011 DUE TO PELVIC PAIN AND ENDOMETRIOSIS. THERE WAS NO ALLEGATION IN THE PATIENT'S OPERATIVE REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. DURING A POST-SURGICAL FOLLOW-UP EXAMINATION ON (B)(6) 2011 THE PATIENT COMPLAINED THAT SHE EXPERIENCED BURNING DURING URINATION. ON (B)(6) 2011 THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM COMPLAINING OF FEVER, CHILLS AND ABDOMINAL PAIN. LAB TESTS PERFORMED REVEALED THAT THE PATIENT'S HAD A SUBSTANTIALLY ELEVATED WHITE BLOOD CELL COUNT SUGGESTIVE OF INFECTION. A CT SCAN SHOWED THICKENING OF THE RECTUM AND A CT SCAN WITH RECTAL AND ORAL CONTRAST WAS ALSO PERFORMED THAT SHOWED A SMALL COLLECTION IN THE PELVIS MEASURING APPROXIMATELY 3CM IN

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 DISCOVERY ACTIVITY, ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI TOTAL HYSTERECTOMY PROCEDURE. ISI WAS PROVIDED WITH A COPY OF THE HOSPITAL'S RISK OCCURRENCE REPORT FROM THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT. THE RISK OCCURRENCE REPORT INDICATED THAT THE PATIENT SUSTAINED A BLADDER INJURY DURING THE SURGICAL PROCEDURE. THE DAMAGE TO THE PATIENT'S BLADDER WAS REPAIRED INTRA-OPERATIVELY WITH THE DA VINCI SURGICAL SYSTEM BY THE HOSPITAL'S UROLOGIST. 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: AS PART OF A LEGAL DISCOVERY ACTIVITY, ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT WAS SCHEDULED TO UNDERGO A DA VINCI BILATERAL SALPINGOOPHORECTOMY PROCEDURE. ISI WAS PROVIDED WITH A COPY OF THE HOSPITAL'S RISK OCCURRENCE REPORT FROM THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT. THE RISK OCCURRENCE REPORT INDICATED THAT THE PATIENT WAS SCHEDULED TO UNDERGO A DA VINCI BILATERAL SALPINGOOPHORECTOMY PROCEDURE; HOWEVER, DURING INSERTION OF A TROCAR, THE PATIENT SUSTAINED A BOWEL INJURY, 0.5 CM IN SIZE. THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, AND BOWEL REPAIR PROCEDURE BY THE SITE'S GENERAL SURGEON. 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: AS PART OF A LEGAL COMPLAINT EFFORT, ON (B)(6) 2013 INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING MEDICAL RECORDS, OF A PATIENT WHO DEVELOPED POST- SURGICAL COMPLICATIONS AFTER HAVING A DA VINCI SI BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2011 FOR A LEFT OVARIAN COMPLEX CYST. THE PATIENT HISTORY SHOWED MULTIPLE ABDOMINAL SURGERIES IN THE PAST AND THE PATIENT WAS EXPECTED TO HAVE A LARGE AMOUNT OF ADHESIONS IN THE SMALL AND LARGE INTESTINE. THE ADHESIONS WERE REMOVED BEFORE BEGINNING THE BSO PROCEDURE. THESE ADHESIONS WERE REMOVED WITH SCISSORS. DURING THE DA VINCI SI PROCEDURE BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE IT WAS NOTED BT THE SURGEON THAT EXTENSIVE OMENTAL AND COLON ADHESIONS WERE REMOVED WITH SCISSORS AND THAT A VERY SMALL RENT IN THE SMALL INTESTINE WAS LIKELY DUE TO A THERMAL BURN WHICH WAS THEN REPAIRED DURING THIS PROCEDURE AND EXCELLENT HEMOSTASIS WAS NOTED. POST- SURGERY THE PATIENT HAD SOME ABDOMINAL PAIN AND SHE WAS DISCHARGED ON (B)(6) 2011. THE FOLLOWING DAY THE PATIENT COMPLAINED ABOUT ABDOMINAL PAIN AND WAS READMITTED ON (B)(6) 2011 WITH ABDOMINAL PAIN AND FEVER. SHE WAS TREATED WITH PAIN MEDICATIONS AND KEFLEX FOR A PROBABLE POSTOPERATIVE IL

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 INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2011. THE DOCUMENTATION RECEIVED STATES THAT THE PATIENT DEVELOPED A URETERAL VAGINAL FISTULA AS A RESULT OF THE SURGICAL PROCEDURE. THE LEGAL CLAIMS ALSO ALLEGED THAT THE PATIENT SUSTAINED KIDNEY DAMAGE THAT WAS CAUSED BY A SERIES OF INFECTIONS SHE CONTRACTED DURING HER POST-SURGICAL STRUGGLES. ADDITIONALLY IT WAS STATED THAT THE PATIENT HAD AN UNREMARKABLE MEDICAL HISTORY BUT HAD BEEN DEALING WITH MENORRHAGIA. PRIOR TO UNDERGOING THE HYSTERECTOMY, THE PATIENT DID NOT HAVE ANY PROBLEMS WITH HER KIDNEYS, URETERS, OR BLADDER. THE OPERATIVE REPORT INDICATED THAT DURING THE DA VINCI SI HYSTERECTOMY PROCEDURE THE PATIENT HAD EXTENSIVE LYSIS OF ADHESIONS AND BILATERAL OVARIAN CYSTECTOMY. AFTER THE PATIENT'S VAGINAL CUFF WAS CLOSED, THE PATIENT WAS GIVEN 5 CC INDIGO CARMINE DYE INTRAVENOUSLY AND CYSTOSCOPY WAS THEN PERFORMED. THE OPERATIVE REPORT STATES THAT THE PATIENT'S RIGHT URETERAL ORIFICE DID NOT HAVE ANY FLOW AFTER OVER 40 MINUTES OF OBSERVATION. A UROLOGIST WAS THEN CONSU

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 REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2011. IT WAS REPORTED IN THE UROLOGIST CONSULT OPERATIVE REPORT THAT AN INJURY TO THE PATIENT'S BLADDER OCCURRED DURING THE HYSTERECTOMY PROCEDURE. THE PLANNED SURGICAL PROCEDURE WAS CONVERTED TO OPEN LAPAROTOMY AND A UROLOGIST WAS CONSULTED TO EVALUATE THE PATIENT'S BLADDER. THE PATIENT'S OPERATIVE REPORT FOR THE DA VINCI HYSTERECTOMY WAS NOT PROVIDED; HOWEVER, THE UROLOGIST'S CONSULTATION REPORT WAS PROVIDED. THE SURGEON STATED IN HIS CONSULTATION REPORT THAT THE ASSESSMENT OF THE PATIENT'S BLADDER FOUND A 1CM DEFECT LOCATED POSTERIOR INFERIOR PORTION OF THE BLADDER. NO OTHER DAMAGE TO THE PATIENT'S BLADDER WAS NOTED. THE REPORTED LACERATION WAS REPAIRED WITH SUTURE. IT WAS NOTED THAT THERE WAS CLEAR EFFLUX FROM BOTH URETERAL ORIFICES. A FOLEY CATHETER WAS PLACED. ON (B)(6) 2011 THE CATHETER WAS REMOVED AND NO COMPLICATIONS WERE NOTED AT THAT TIME. 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI ROBOTIC HYSTERECTOMY FOR ENLARGED UTERINE FIBROIDS PROCEDURE ON (B)(6) 2011. PATIENT WAS DISCHARGED ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDE HOSPITAL OPERATIVE REPORTS AND RADIOLOGY FINDINGS. ON (B)(6) 2011, THE PATIENT WENT TO THE HOSPITAL TO HAVE THE FOLLOWING PROCEDURE: CYSTOSCOPY, RIGHT RETROGRADE PYELOGRAMS, FLUOROSCOPY, CYSTOGRAM, PELVIC EXAM UNDER ANESTHESIA. DX: RIGHT HYDRONEPHROSIS, RIGHT URETERAL VAGINAL FISTULA¿.HAS A RIGHT URETERAL VAGINAL FISTULA. ON (B)(6) 2011 A RIGHT PERCUTANEOUS NEPHROSTOMY TUBE PLACEMENT. ON (B)(6) 2012, THE PATIENT HAD THE FOLLOWING PROCEDURE: RIGHT URETERAL NEOCYSTOSTOMY (RIGHT URETERAL REIMPLANT). OX: RIGHT URETERAL VAGINAL FISTULA. THE PATIENT WAS DISCHARGED ON (B)(6) 2012 WITH FOLEY CATHETER. THE PATIENT CONTINUES TO HAVE FREQUENT URINARY TRACT INFECTIONS, URGENCY, FREQUENCY, STRESS INCONTINENCE AND NOCTURIA. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATI

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. RECEIVED A VOLUNTARY REPORT (B)(4) WITH THE FOLLOWING DESCRIPTION: I WAS NEEDING SURGERY FOR MINOR COLON CANCER. I WAS PLANNING ON RETURNING TO WORK WITHIN 5 WEEKS. MY DOCTOR AT XX HOSPITAL INSISTED THAT I DO ROBOTIC SURGERY. ALL THE PROS AND CONS WERE STATED FOR ME. AFTER SURGERY, I HAD A LARGE HOLE IN MY VAGINA. MORE SURGERY WAS DONE TO TRY TO REPAIR DAMAGE. IT WAS UNSUCCESSFUL. I ENDED UP WITH AN ILEOSTOMY FOR MONTHS, WAITING FOR VAGINA TO HEAL. MY BLADDER WAS DAMAGED AND HAS NEVER WORKED. NOW I USE CATHS. I WAS TOLD THAT MY BLADDER WAS BADLY BEATEN UP WITH ROBOTIC SURGERY. IT WAS 6 MONTHS BEFORE I COULD WORK. I SWITCHED HOSPITALS. AT XX HOSPITAL, I WAS TOLD BY DOCTORS THAT COLON SURGERY FOR FEMALES SHOULD NEVER BE DONE BY ROBOTICS. I RECENTLY SAW A REPORT ON NBC AND REALIZED THAT I AM NOT THE ONLY ONE MESSED UP FOR LIFE BECAUSE OF THIS ROBOTIC SURGERY. PLEASE STOP THE DOCTORS AND HOSPITALS FROM "PUSHING" THIS SURGERY. I WAS THE EXPERIMENTAL RATE OF THE DAY. IT CLEARLY SUCKS. I WAS TOLD BY A LAWYER THAT IF I PURSUED A LAWSUIT THAT THERE WAS NO WINNING AGAINST A BIG CORPORATION LIKE THE MEDICAL FIELD. PATIENT AND HOSPITAL INFORMATION NAMES

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI ROBOTIC HYSTERECTOMY FOR HYPERPLASIA PROCEDURE ON (B)(6) 2011. 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) 2011, THE PATIENT UNDERWENT LAPAROSCOPY, LYSIS OF ADHESIONS, ROBOTIC HYSTERECTOMY, BILATERAL PELVIC LYMPHADENECTOMY, AND CYSTOSCOPY. THE OPERATIVE REPORT INDICATED, EXTENSIVE ADHESIONS AND EXPOSURE. THE OPERATIVE REPORT ALSO INDICATED THE USE OF HARMONIC SCALPEL AND CAUTERY. THE PATIENT WAS DISCHARGED ON (B)(6) 2011 IN STABLE CONDITION. ON (B)(6) 2011, THE PATIENT RETURNED TO HOSPITAL AFTER CT NOTED POSSIBLE ABSCESS VERSUS ENTEROCUTANEOUS FISTULA. ON (B)(6) 2011, THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY AND NOTED EXTENSIVE ADHESIONS AS WELL AS SMALL DEFECT IN SMALL BOWEL RESECTED WITH END-TO-END ANASTOMOSIS. NOTED OF AREAS OF INDURATION ON BOWEL. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION ON (B)(6) 2011.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI S NISSEN FUNDOPLICATION PROCEDURE, THE SURGICAL STAFF OBSERVED THE BIPOLAR INSTRUMENT TO HAVE ENERGIZED WITHOUT THE FOOTPEDAL BEING PRESSED RESULTING IN A BURN TO THE PATIENT'S LIVER. THE BIPOLAR INSTRUMENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING REPLACEMENT INSTRUMENTS. THE SITE REPORTED THAT THE PATIENT IS DOING FINE; HOWEVER, IT IS UNKNOWN IF OR HOW THE PATIENT WAS TREATED. AN ERROR IN THE INITIAL REVIEW OF THIS EVENT RESULTED IN A DELAY OF THE SUBMISSION OF THIS 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY, RIGHT OVARIAN CYSTECTOMY, AND LYSIS OF ADHESIONS ON (B)(6) 2011 FOR ABNORMAL BLEEDING, OVARIAN CYST, AND PELVIC ORGAN PROLAPSE. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES SUBSEQUENT MEDICAL RECORDS REGARDING THE FINDING OF A PELVIC ABSCESS. THERE WAS INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SI SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2011, THE PATIENT PRESENTED WITH LOWER ABDOMINAL PAIN AND A BROWNISH DISCHARGE. A PELVIC CT SHOWED AN 8 X 8 CM PELVIC AND ABDOMINAL FLUID COLLECTION. ON (B)(6) 2011, THE PATIENT UNDERWENT A CT GUIDED PROCEDURE TO DRAIN THIS FLUID COLLECTION. THE PROCEDURE WAS SUCCESSFUL. THE PATIENT WAS STARTED ON IVANZ ANTIBIOTIC. ASPIRATION YIELDED BROWNISH MALODOROUS FLUID. 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: AS PART OF A LEGAL MEDIATION EFFORT ON (B)(6) 2013 INTUITIVE SURGICAL RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT HAD A DA VINCI SI HYSTERECTOMY AND RIGHT SALPINGO OOPHORECTOMY PROCEDURE ON (B)(6) 2011. NO COMPLICATIONS WERE NOTED DURING THE DA VINCI SI SURGICAL PROCEDURE. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. THE PATIENT CAME BACK TO THE HOSPITAL ON (B)(6) 2011 WITH SYMPTOMS OF ABDOMINAL PAIN AND URINARY LEAKAGE. THE PATIENT WAS EVALUATED AND A CT SCAN OF THE ABDOMEN AND PELVIS SHOWED MILD HYDRONEPHROSIS, WITH SPILLAGE OF CONTRAST INTO THE ABDOMEN. THE PATIENT HAD PERCUTANEOUS STENTING OF BOTH URETERS. THERE WERE NO COMPLICATIONS NOTED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2011. PER THE MEDICAL RECORDS PROVIDED, THE PATIENT WENT BACK TO THE HOSPITAL ON (B)(6) 2011 WITH A COMPLAINT OF LEAKING FROM THE VAGINA. ON (B)(6) 2011 THE PATIENT WENT IN SURGERY FOR PELVIC EXPLORATION. THE SURGEON PERFORMED A BILATERAL URETERAL REIMPLANTATION AND CLOSURE OF THE LEFT URETEROVAGINAL FISTULA. A SUPRAPUBIC TUBE WAS PLACED AND THE PATIENT TOLERATED THE SURGICAL PROCEDURE WELL. THE PATIENT WAS DISCH

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 CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY, AND HIGH UTEROSACRAL SUSPENSION PROCEDURE ON (B)(6) 2011. THE MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED A POST-OPERATIVE COMPLICATION. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD A PREOPERATIVE DIAGNOSIS OF PELVIC ENDOMETRIOSIS, DYSPAREUNIA, AND ABDOMINAL PAIN. THE MEDICAL RECORDS ALSO REVEALED THAT THE PATIENT WAS TREATED ON MULTIPLE OCCASIONS FOR INTERSTITIAL CYSTITIS AND DYSURIA BETWEEN (B)(6) 2011 THROUGH (B)(6) 2012. THE PATIENT WAS TREATED WITH SILVER NITRATE INSTILLATIONS AND/OR UNDERWENT BLADDER CATHETERIZATIONS. ACCORDING TO THE OPERATIVE REPORT, AFTER UNDERSTANDING THE NATURE AND RISKS OF THE PROCEDURE, THIS PATIENT SIGNED INFORMED CONSENT. THE SURGEON STATED THAT THE DA VINCI SI SURGICAL PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. THE SURGEON CLOSED THE VAGINAL CUFF WITH SUTURES AND STATED IN THE OPERATIVE REPORT THAT EXCELLENT VAGINAL CUFF SUPPORT WAS NOTED. THE PATIENT TOLERATED THE PROCEDURE WELL AND AT THE COMPLETIO

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 DEMAND LETTER AND MEDICAL RECORDS INVOLVING A PATIENT WHO REPORTEDLY SUFFERED FROM POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2011. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT'S PRE-OPERATIVE DIAGNOSIS WAS PELVIC PAIN, ABNORMAL UTERINE BLEEDING, AND DYSPAREUNIA. THE PATIENT'S CERVIX AND UTERUS WERE REMOVED WITHOUT COMPLICATIONS AND THE PATIENT TOLERATED THE PROCEDURE WELL. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. ACCORDING TO THE DEMAND LETTER, THE PATIENT STARTED TO HAVE PROBLEMS WITH PELVIC PAIN AND VAGINAL DRAINAGE AND SHE STATED SHE FELT AS IF SOMETHING CAME LOOSE FROM MY BODY ON AN UNSPECIFIED DATE. ON (B)(6) 2012, APPROXIMATELY 4 MONTHS AFTER THE DA VINCI SURGICAL PROCEDURE, THE PATIENT WAS DIAGNOSED WITH A VAGINAL CUFF PERFORATION, CUFF DEHISCENCE, AND MILD PERITONITIS. THE PATIENT UNDERWENT DIAGNOSTIC LAPAROSCOPY AND LAPAROSCOPIC REPAIR OF THE CUFF PERFORATION AND CUFF DEHISCENCE. PER THE (B)(6) 2012 OPERATIVE REPORT, THERE WAS A PIECE OF OMENTUM THAT WAS PROTRUDING THROUGH THE VAGINAL PERFO

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 SI TOTAL HYSTERECTOMY FOR SYMPTOMATIC UTERINE FIBROIDS AND MENOMETRORRHAGIA ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL OPERATIVE , RADIOLOGY, AND OPERATIVE 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. ON (B)(6) 2011 THE PATIENT PRESENTED WITH INCONTINENCE. IVP PERFORMED SHOWING LEFT URETERAL INJURY WITH URETEROVAGINAL FISTULA ON (B)(6) 2011 CYSTOSCOPY AND STENT PLACEMENT ON (B)(6) 2011 NEPHROSTOMY FOR PERSISTENT FISTULA ON (B)(6) 2012 VESICOVAGINAL FISTULA REPAIR WITH REIMPLANTATION OF LEFT URETER.

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 9 DAYS POST A SUCCESSFUL DA VINCI S HYSTERECTOMY PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL WITH COMPLICATIONS AND WAS FOUND TO HAVE A DAMAGED URETER.

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. RECEIVED A VOLUNTARY REPORT MW5031642 WITH THE FOLLOWING DESCRIPTION: I HAD A DA VINCI ROBOTIC HYSTERECTOMY ON (B)(6) 2011. I HAD PAIN AFTER THE SURGERY THAT DID NOT GO AWAY. EIGHT DAYS AFTER SURGERY, I BEGAN LEAKING URINE. ULTIMATELY IT WAS DISCOVERED THAT MY BLADDER HAD BEEN CUT DURING THE SURGERY. BLADDER WAS LEAKING AND INFECTED.

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 WITH BILATERAL SALPINGO-OOPHORECTOMY FOR UTERINE FIBROIDS AND ENDOMETRIOSIS ON (B)(6) 2011. 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. THE OPERATIVE NOTE STATES THAT THERE WERE EXTENSIVE ADHESIONS POSTERIORLY AND THAT THERE WAS POOR VISUALIZATION POSTERIORLY. SHE UNDERWENT A DIFFICULT HYSTERECTOMY DUE TO ENDOMETRIOSIS. SHE BECAME ANURIC POSTOPERATIVELY. THE CT SCAN DEMONSTRATED BILATERAL URETERAL OBSTRUCTION. IN THE OR THE URETERS WERE FOUND TO BE OBSTRUCTED AT THE VAGINAL CUFF AND POSTERIOR BLADDER. A BILATERAL URETERAL REIMPLANTATION WAS PERFORMED SUCCESSFULLY. THE STENTS WERE REMOVED ON (B)(6) 2012.

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, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL URETEROLYSIS, BILATERAL PELVIC LYMPH NODE DISSECTION ON (B)(6) 2011 FOR ENDOMETRIAL ADENOCARCINOMA OF THE UTERUS. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT FOR THE PRIMARY SURGERY AND THE URETERAL REIMPLANTATION. NO MEDICAL HISTORY WAS PROVIDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THE SURGERY WAS NOTABLE FOR EXTENSIVE SIGMOID ADHESIONS TO THE LEFT PELVIC SIDEWALL AND LEFT ADNEXA. THE HYSTERECTOMY PROCEEDED WITH SEQUENTIAL LIGATION AND DIVISION OF THE ROUND LIGAMENTS, INFUNDBULO PELVIC LIGAMENTS WITH CARE TO IDENTIFY AND LOCALIZE THE URETER. URETEROLYSIS WAS PERFORMED DUE TO INVOLVEMENT AND INDURATION OF THE PERIRECTAL AND PERIVESICAL SPACES. THE BLADDER WAS SHARPLY DISSECTED AND THE UTERINE VESSELS AND THE CARDINAL LIGAMENTS LIGATED AND CUT. THE CULPOTOMY WAS MADE, AND THE UTERUS DELIVERED THROUGH THE VAGINA. THE VAGINAL CUFF WAS CLOSED WITH RUNNING SUTURES, AND THE PELVIC LYMPH NODE DISSECTION COMPLETED

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 25, 2013 INTUITIVE SURGICAL, INC. RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI SACROCOLPOPEXY PROCEDURE ON (B)(6) 2011 DUE TO PELVIC PROLAPSE. THERE WAS NO REPORT IN THE PATIENT'S OPERATIVE (OP) REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS. IT WAS STATED IN THE OP REPORT THAT AFTER THE SURGICAL TASK OF SECURING THE PATIENT'S VAGINAL MESH WAS PERFORMED, EXCELLENT HEMOSTASIS WAS NOTED. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. ON (B)(6) 2011 THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM COMPLAINING OF LOWER ABDOMINAL PAIN AND SHOULDER PAIN. THE PATIENT UNDERWENT A DIAGNOSTIC TEST AND IT WAS DISCOVERED THAT SHE HAD A SMALL AMOUNT OF FREE AIR. A CHEST X-RAY WAS PERFORMED AND THE PATIENT BECAME PROGRESSIVELY WORSE IN HER SYMPTOMS. ON EXAMINATION, THE PATIENT WAS IN FAIRLY ACUTE DISTRESS. A CBC TEST SHOWED THAT 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI DIAGNOSTIC LAPAROSCOPY, EXTENSIVE PELVIC ADHESIOLYSIS, BILATERAL URETEROLYSIS, STRIPPING OF THE PELVIC SIDEWALL PERITONEUM, RESECTION OF A RIGHT OVARIAN REMNANT, AND PARTIAL UPPER VAGINECTOMY ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES, HISTORY AND PHYSICAL EXAM, 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 PATIENT DEVELOPED A PULMONARY EMBOLISM FOLLOWING SURGERY AND REQUIRED ANTICOAGULATION WITH COUMADIN. ON (B)(6) 2011 THE PATIENT HAD A CONSULTATION WITH A UROLOGIST FOR AN APPARENT URETEROVAGINAL FISTULA WITH DISTAL RIGHT URETER INJURY. A CT UROGRAM WAS PERFORMED AT HER HOME AFTER SHE BEGAN HAVING LEAKING FLUID PER VAGINA. ON (B)(6) 2011 THE PATIENT WAS ADMITTED TO A MEDICAL CENTER AND DIAGNOSED WITH A URETEROVAGINAL AND URETEROENTERIC FISTULA. SHE UNDERWENT A CYSTOSCOPY WITH ATTEMPTED URETERAL STENT BUT INSTEAD REQUIRED A PERCUTANEOUS NEPHROSTOMY. ON (B)(6) 2012 THE PA

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) 2011. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: SWELLING ON RIGHT SIDE, HERNIA WHICH WAS VERY PAINFUL, ERECTIONS TOUGH, LEAKS URINE, PAINFUL TO TOUCH, AND EXPERIENCED BLADDER PROBLEMS.

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 THE BEGINNING OF A DA VINCI SI PROSTATECTOMY AND LYMPHADENECTOMY PROCEDURE, THE SURGEON GRASPED THE PATIENT'S COLON WITH THE MARYLAND BIPOLAR FORCEPS INSTRUMENT AND ENERGY BEGAN TO EMIT WITHOUT THE FOOT PEDAL HAVING BEEN ACTIVATED. THE SURGEON IMMEDIATELY REMOVED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT AND FOUND THE ELECTRICAL SURGICAL UNIT (ESU) SETTING WAS PLACED ON AUTO. THE ESU SETTING WAS CHANGED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THE PATIENT'S COLON WAS REPAIRED AND NO FURTHER ADVERSE EVENT 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, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2011 FOR UTERINE PLACENTAL SITE TROPHOBLASTIC TUMOR. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. THE INFUNDIBULOPELVIC LIGAMENT WAS ISOLATED AND THE UTERO-OVARIAN LIGAMENT WAS CAUTERIZED, AS WAS THE PROXIMAL FALLOPIAN TUBE. THE OVARIES WERE TUCKED AWAY. THE BLADDER FLAP WAS CREATED AND TAKEN DOWN WITHOUT DIFFICULTY. THE VCARE CONE BULGE WAS EASILY SEEN. AFTER REMOVAL OF THE UTERUS, THE CUFF WAS CLOSED TIGHTLY WITH SUTURE. THE PATIENT WAS BEING REVERSED AT THE TIME OF THE OPERATIVE NOTE, AND TOLERATED THE PROCEDURE WELL. SHE WAS DISCHARGED ON (B)(6) 2011 FOR A TOTAL HOSPITAL STAY OF THREE DAYS. ON (B)(6) 2011, THE PATIENT WAS ADMITTED FOR PELVIC PAIN AND A FLUID COLLECTION SUSPICIOUS FOR VAGINAL CUFF ABSCESS ON A CT SCAN. INTERVENTIONAL RADIOLOGY DRAINED SAID ABSCESS. THE VAGINAL CUFF LOOKED FINE UPON PHYSICAL EXAMINATION. SHE WAS DISCHARGED HOME ON (B)(6) 2011. NO ADDITIONAL INFORMATION IS AVAILABLE AFTER HER 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: IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE THE SURGEON EXPERIENCED INSUFFLATION LOSS AT THE CAMERA TROCAR. THE SITE REPLACED THE CAMERA TROCAR; HOWEVER, THE INSUFFLATION LOSS PERSISTED. AT THIS TIME THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. NO SYSTEM MALFUNCTION OCCURRED.

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 RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI SI VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND CYSTOSCOPY IN ADDITION TO A RIGHT INGUINAL HERNIA REPAIR WITH MESH PLACEMENT ON (B)(6) 2011. THE OPERATIVE REPORT DOES NOT CONTAIN ANY REPORT OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. POST-OPERATIVELY, THE PATIENT COMPLAINED OF PELVIC PAIN. ON (B)(6) 2011 THE PATIENT HAD A CT SCAN OF THE ABDOMEN AND PELVIS WHICH SHOWED OVARIAN VEIN THROMBOSIS. THE PATIENT WAS STARTED ON LOVENOX AND ANTIBIOTICS AND TRANSITIONED TO COUMADIN (ANTI-COAGULANT). ON (B)(6) 2011 THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY; THE POST- OPERATIVE DIAGNOSIS WAS VAGINAL CUFF BLEEDING. A SMALL ADHESION WAS TAKEN DOWN THAT WAS ATTACHED TO THE INGUINAL HERNIA REPAIR SITE. THE PATIENT ALSO RECEIVED 3 BLOOD TRANSFUSIONS DURING THAT ADMISSION, ACCORDING TO THE MEDICAL RECORDS. AT THE PATIENT'S 6 WEEK POSTOPERATIVE HYSTERECTOMY CHECKUP ON (B)(6) 2011, THE PATIENT COMPLAINED OF OCCASIONAL RANDOM PAIN FROM HER HERNIA REPAIR BUT WAS DOING WELL OTHERWISE. IN (B)(6) 2012, SHE REPORTED HAV

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 07/25/2013, INTUITIVE SURGICAL RECEIVED INFORMATION OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2011 FOR SEVERE CERVICAL DYSPLASIA. THIS PATIENT HAD A FAMILY HISTORY OF OVARIAN CANCER. PRIOR TO THE PROCEDURE, THE PATIENT WAS INFORMED OF THE SURGERY RISKS, INCLUDING CUFF DEHISCENCE, PORT CUFF HEALING. THE PATIENT AGREED AND SIGNED THE CONSENT TO PROCEDURE AND RISKS THEREOF. THE MONOPOLAR SCISSORS INSTRUMENT WAS USED TO TRANSECT THE VAGINAL CUFF FROM THE CERVIX AND WAS DONE IN A CIRCUMFERENTIAL MANNER. THE PATIENT'S ENTIRE CERVIX, UTERUS, TUBES, AND OVARIES WERE REMOVED. THE SURGEON NOTED ACHIEVING EXCELLENT VAGINAL CUFF CLOSURE AFTER SUTURING AS WELL AS APPLYING AN INTERCEED ADHESION BARRIER TO THE CUFF. THE DA VINCI SYSTEM WAS UNDOCKED AND THE PROCEDURE SWITCHED TO TRADITIONAL LAPAROSCOPE FOR THE REMAINDER OF THE PROCEDURE. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT HAD 3 POST-OPERATIVE CHECK-UPS WITH HER DOCTOR FROM (B)(6) 2011. DURING THESE VISITS, HER VAGINAL CUFF WAS NOTED TO BE INTACT AND HEALING WELL. APPROXIMATELY 2 MONTHS AFTER THE DA VIN

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2011 DUE TO PROSTATIC CANCER, STAGE T1C. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT. ADDITIONAL INFORMATION WAS PROVIDED INCLUDED THE PATIENT'S ATTORNEY CLAIM FORM. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGICAL PROCEDURE. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION. REPORTEDLY, THE PATIENT TOLERATED THE SURGICAL PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE AND SATISFACTORY CONDITION. NO OTHER PATIENT MEDICAL RECORDS WERE PROVIDED. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED IN THE PATIENT'S CLAIM FORM: ON (B)(6) 2011, AN EXPLORATORY LAPAROTOMY WITH SMALL BOWEL RESECTION, ABDOMINAL WASHOUT AND WOUND VAC PLACEMENT WAS PERFORMED. OPERATIVE FINDINGS INCLUDE: GROSS ENTERIC SPILLAGE WITH PARTICULATE MATTER, NO PUS, SMALL BOWEL INJURY APPROX 1 CM IN SIZE IN THE MID ILEUM, REMAINING SMALL BOWEL AND LARGE BOWEL APPEARED INTACT, STOMACH WAS NORMAL. ON (B)(6) 2011 - ABDOMINAL WASHOUT WITH ABDOMINAL VAC DRESSING

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 INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2011. THE DOCUMENTATION RECEIVED STATES THAT THE PATIENT DEVELOPED A PELVIC ABSCESS AFTER UNDERGOING THE SURGICAL PROCEDURE. THE PATIENT'S OPERATIVE REPORT STATED THAT EXTREME SCAR TISSUE AND AN EXTREMELY LARGE FUNDAL FIBROID WERE OBSERVED. DUE TO THE SIZE OF THE UTERUS, THE UTERUS WAS CUT IN HALF AND REMOVED VAGINALLY. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT TOLERATED THE PROCEDURE WELL AND SHE WAS TAKEN TO RECOVERY WITHOUT SEQUELAE. ON (B)(6) 2011, THE PATIENT WAS EVALUATED IN AN EMERGENCY ROOM (ER) FOR REPORTED COMPLAINTS OF ABDOMINAL PAIN, NAUSEA, VOMITING, AND FEVER. A CT SCAN PERFORMED ON THE PATIENT'S ABDOMEN AND PELVIS REVEALED A PELVIC ABSCESS WITH STOOL-LIKE MATERIAL WITHIN. ON (B)(6) 2011, THE PATIENT UNDERWENT PERCUTANEOUS DRAINAGE OF THE PELVIC ABSCESS. A TOTAL OF 15 ML OF PURULENT FLUID WAS REMOVED. IN ADDITION, PLACEMENT OF A DRAINAGE CATHETER WAS PERFORMED. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, THE PATIENT TOLERATED THE PROCEDURE WELL AND NO IMM

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 ACCIDENTALLY CUT THE PATIENT'S HYPOGASTRIC NERVE. THE PROCEDURE WAS CONVERTED TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE AND REPAIR THE PATIENT'S HYPOGASTRIC NERVE. NO SYSTEM MALFUNCTION OCCURRED.

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 OVARY REMOVAL ON (B)(6) 2011. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PERFORATED HER INTESTINE IN ERROR, PAIN, URINARY AND BOWEL PROBLEMS AND CAN FEEL INCISION.

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. RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI OVARIAN CYSTECTOMY PROCEDURE (B)(6) 2011. ON (B)(6) 2011 THE PATIENT RETURNED TO THE HOSPITAL EMERGENCY ROOM COMPLAINING OF SEVERE ABDOMINAL PAIN IN THE PERIUMBILICAL AREA. DURING A CT SCAN IT WAS DISCOVERED THAT THE PATIENT HAD AN INCARCERATED HERNIA. ON (B)(6) 2011, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPAIR THE HERNIA. THE PATIENT'S OPERATIVE (OP) REPORT FOR THE SURGICAL PROCEDURE OF (B)(6) 2011 ALLEGED THAT DURING THE DA VINCI SI OVARIAN CYSTECTOMY PROCEDURE, IT WAS NOTED THAT THE PATIENT SIDE MANIPULATOR ARMS ON THE PATIENT SIDE CART COLLIDED A LOT WHILE DOCKED TO A SINGLE PORT SITE. TO RESOLVE THE ISSUE, THE SURGEON MADE THE DECISION TO CREATE ADDITIONAL PORT SITES TO PERFORM THE PROCEDURE USING MULTIPLE PORTS. THERE WERE NO OTHER SYSTEM ISSUES DOCUMENTED IN THE OP REPORT. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. A CT SCAN OF THE PATIENT'S ABDOMEN

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED AN OPERATIVE REPORT AND A LEGAL DOCUMENT FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2011. DURING THE DA VINCI HYSTERECTOMY PROCEDURE A NEEDLE FELL IN PATIENT. PER THE OPERATIVE REPORT THE SURGEON STATED THAT THE NEEDLE WAS LOST UPON TRYING TO REMOVE IT FROM THE PORT. ATTEMPTS WERE MADE TO FIND THE NEEDLE AND AN X-RAY AND FLUOROSCOPY WERE PERFORMED AND THE NEEDLE WAS LOCATED IN THE RIGHT UPPER QUADRANT AND WAS REMOVED THROUGH THE TROCAR SLEEVE INTACT. NO FURTHER COMPLICATIONS WERE NOTED, AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM POST- PROCEDURE. THIS LEGAL DOCUMENT ALLEGES THAT THE PATIENT'S BOWL MAY HAVE BEEN INJURED BY UNINTENDED AND UNKNOWN RELEASE OF MONOPOLAR ENERGY FROM THE CAUTERY DEVICE OF THE ROBOT. ACCORDING TO THE LEGAL DOCUMENT, APPROXIMATELY AFTER 8 DAYS OF WORSENING SYMPTOMS, THE PATIENT BECAME SEPTIC. ON (B)(6) 2011, A LAPAROTOMY WITH WASHOUT OF ABDOMEN AND SMALL BOWEL RESECTION WAS PERFORMED. IT WAS ALLEGED IN THE LEGAL DOCUMENT THAT DURING THIS PROCEDURE, THE PATIENT WAS FOUND TO HAVE PERITONITIS, AND PERFORATION OF THE SMALL INTESTINE. ON (B)(6) 2011,

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 PYELOPLASTY PROCEDURE, THE SURGEON OBSERVED ENERGY COMING FROM BOTH THE MONOPOLAR AND BIPOLAR INSTRUMENTS WHEN THE MONOPOLAR CAUTERY WAS INTENDED TO BE ACTIVATED. THE PATIENT EXPERIENCED A SMALL BOWEL INJURY WHICH WAS SUCCESSFULLY RESECTED. THE PATIENT WAS HOSPITALIZED FOR 2.5 WEEKS BEFORE BEING DISCHARGED HOME. NO FURTHER INFORMATION HAS BEEN PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2011. ACCORDING TO THE LEGAL DOCUMENT, THE PATIENT WAS REPORTED TO HAVE SUSTAINED A PUNCTURED COLON 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)(6) 2011, I HAD A TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY USING THE DA VINCI INTERFACE. I SUFFERED A COMPLETE TRANSECTION OF THE RIGHT DISTAL URETER. POST OP I DEVELOPED A FISTULA WITH URETERAL STRICTURE. I HAD A SURGICAL REPAIR ON (B)(6) 2011, WHICH DID NOT CHANGE THE TOTAL URINARY INCONTINENCE I SUFFERED AS A RESULT OF THE INITIAL SURGERY WITH THE DA VINCI. THE SECOND SURGERY DID NOT HELP AND (B)(6) 2014, I HAD ANOTHER REPAIR. I AM STILL SUFFERING FROM SEVERE INCONTINENCE.

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, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI SI SACROCOLPOPEXY PROCEDURE ON (B)(6) 2011 FOR VAGINAL PROLAPSE. THE OPERATIVE NOTES INDICATE THAT THE PATIENT'S UTERUS AND RIGHT ADNEXA WERE ABSENT AND THE LEFT ADNEXA AND LEFT SIGMOID COLON WERE SCARRED TOGETHER. THE USE OF MONOPOLAR SCISSORS AND PK INSTRUMENTS WERE MENTIONED IN THE PROCEDURE NOTES, BUT THERE WAS NO REPORT OF A DA VINCI SI SYSTEM OR INSTRUMENT MALFUNCTION. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. ACCORDING TO THE MEDICAL RECORD, THE PATIENT DID NOT HAVE ANY COMPLICATIONS WITH THE DA VINCI SI SURGICAL PROCEDURE. THE PATIENT HAD SOME LOW BACK PAIN THAT WAS FELT TO BE RELATED TO POSITIONING THAT KEPT HER FROM AMBULATING QUICKLY. SHE WAS DISCHARGED TO RETURN HOME ON HOSPITAL DAY NUMBER THREE. IN (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH A PELVIC ABSCESS, DIVERTICULITIS OF THE COLON WITH PERFORATION, AND HAD A SIGMOID COLECTOMY. THE PATIENT NOTED AS BEING HOSPITALIZED SEVERAL TIMES THROUGHOUT (B)(6) 2011 THROUGH (B)(6) 2012, FOR BACK AND LEG ISSU

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 02/03/2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED VOLUNTARY REPORT MW5038369 WITH THE FOLLOWING EVENT DESCRIPTION: ON (B)(6) 2011, I HAD A TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY USING THE DA VINCI INTERFACE. I SUFFERED A COMPLETE TRANSECTION OF THE RIGHT DISTAL URETER. POST OP I DEVELOPED A FISTULA WITH URETERAL STRICTURE. I HAD A SURGICAL REPAIR ON (B)(6) 2011, WHICH DID NOT CHANGE THE TOTAL URINARY INCONTINENCE I SUFFERED AS A RESULT OF THE INITIAL SURGERY WITH THE DA VINCI. THE SECOND SURGERY DID NOT HELP AND (B)(6) 2014, I HAD ANOTHER REPAIR. I AM STILL SUFFERING FROM SEVERE INCONTINENCE. ON 02/25/2015, ISI CONTACTED THE PATIENT DIRECTLY AND OBTAINED THE FOLLOWING INFORMATION: THERE WERE NO REPORTS MADE TO HER FROM THE SITE THAT A MALFUNCTION OF THE DV SURGICAL SYSTEM OCCURRED DURING THE PROCEDURE. TO HER KNOWLEDGE, THE PATIENT EXPLAINED THAT DURING THE DV SURGICAL PROCEDURE, HER URETER WAS COMPLETELY CUT AND ANOTHER SURGEON WAS CALLED IN TO TRY AND REPAIR THE URETER. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON (B)(6) 2011 WITH A FEVER. ON (B)(6) 2011, THE PATIENT WAS SEEN BY ANOTHER PHYSICIAN DUE TO THE FEVER. NO ADDITIONAL INFORMATION WAS PROVIDED 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI BLADDER LIFT ON (B)(6) 2011. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURY DUE TO THE DA VINCI SURGERY: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: AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT THAT UNDERWENT A DA VINCI SI RIGHT SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2011. PER THE RECORDS RECEIVED THE SURGERY WAS UNREMARKABLE. IMMEDIATELY FOLLOWING THE INITIAL SURGERY, THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM FOR HYPOTENSION AND WAS NOTED TO HAVE A LARGE AMOUNT OF BLOOD IN THE UPPER ABDOMEN AND PELVIS. THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY WHICH WAS CONVERTED TO AN EXPLORATORY LAPAROTOMY WITH NO CLEAR FINDING IN REGARD TO THE ABSOLUTE SOURCE OF THE BLEEDING. THE PATIENT WENT TO THE RECOVERY ROOM IN A STABLE CONDITION. THE PATIENT RECOVERED WELL AND WAS DISCHARGED ON DAY 5 ((B)(6) 2011) THE PATIENT WAS THEN SEEN AND READMITTED ON (B)(6) 2011, WITH A PERI-HEPATIC ABSCESS. THE PATIENT REQUIRED ANTIBIOTICS AND A FOUR DAY HOSPITALIZATION, AND UNDERWENT A CT GUIDED INTERVENTIONAL RADIOLOGY DRAINAGE OF THE ABSCESS. PER THE INITIAL OPERATIVE REPORT FOR THE (B)(6) 2011 PROCEDURE, THE PATIENT TOLERATED THE OOPHORECTOMY PROCEDURE WELL. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM REPORTEDLY IN STABLE CONDITION. PER THE DI