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, MEDWATCH UF/IMPORTER REPORT (B)(4) WAS RECEIVED: EVENT DESC: THE PATIENT SAFETY CONCERN REGARDING THE DAVINCI ROBOT IS A POSSIBLE DESIGN ISSUE. THE PATIENT SUFFERED A COMPARTMENT SYNDROME OF THE RIGHT LOWER EXTREMITY (RLE) AFTER THE ROBOTIC-ASSISTED LAPAROSCOPY (WITH PROCEDURES). IT IS FELT THAT THE ROBOTIC ARM, WHILE DOCKED ON THE RIGHT SIDE OF THE PATIENT, EITHER BUMPED AND/OR RESTED ON THE PATIENT'S RLE. THIS WAS A 7 HOUR PROCEDURE. THE PATIENT REQUIRED EMERGENCY, 4-COMPARTMENT FASCIOTOMY FOLLOWED BY ANOTHER SURGERY FOR SKIN GRAFT (PLUS WOUND VAC) AND WOUND CLOSURE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? DA VINCI ROBOTIC-ASSISTED LAPAROSCOPY WITH LYSIS OF ADHESIONS, RESECTION OF ENDOMETRIOSIS, BILATERAL SALPINGECTOMY, CYSTOSCOPY, AND PELVIC FLOOR BOTOX INJECTION.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI NISSEN FUNDOPLICATION AND HIATAL HERNIA REPAIR PROCEDURE ON (B)(6) 2012. THE PATIENT REPORTEDLY SUSTAINED A LACERATION TO THE PORTAL VEIN DURING THE SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY ON (B)(6) 2012. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR THE PATIENT'S MEDICAL RECORDS. ACCORDING TO THE LEGAL DOCUMENT PROVIDED, WHILE THE SURGEON WAS DISSECTING AWAY MESENTERY IN THE AREA OF THE LESSER CURVATURE OF THE STOMACH, SIGNIFICANT BLEEDING WAS ENCOUNTERED AND A LATERAL LACERATION TO THE MEDIAL ASPECT OF THE PORTAL VEIN WAS THEN IDENTIFIED. AFTER RECOGNIZING THE VESSEL INJURY, THE SURGEON MADE THE DECISION TO CONVERT TO AN OPEN PROCEDURE AND ENTERED THE PATIENT'S ABDOMEN THROUGH A VERTICAL MIDLINE INCISION. VASCULAR SURGERY WAS THEN CONTACTED FOR ASSISTANCE. WHILE VASCULAR SURGERY WAS EN ROUTE, THE SURGEON CROSS CLAMPED THE PORTAL VEIN, PROCEEDED WITH THE NISSEN FUNDOPLICATION PROCEDURE, AND COMPLETED THE ORIGINALLY INTENDED PROCEDURE. UPON ARRIVING IN THE OPERATING ROOM, A VASCULAR SURGEON IDENTIFIED A LATERAL LACERATION TO THE MEDIAL ASPECT OF

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO EXPIRED AT THE BEGINNING OF A PLANNED DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. AT THE TIME OF THE EVENT, THE DA VINCI SI SYSTEM HAD NOT YET BEEN DOCKED TO THE PATIENT. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD PREOPERATIVE DIAGNOSIS OF UTERINE LEIOMYOMA, REFRACTORY TO MEDICAL MANAGEMENT. ACCORDING TO THE OPERATIVE NOTE, THE GENERAL ENDOTRACHEAL ANESTHESIA WAS ESTABLISHED PRIOR TO STARTING THE SURGICAL PROCEDURE. THE SURGEON MADE A HORIZONTAL INCISION IN THE PATIENT'S UMBILICUS WITH A SCALPEL AND A VERESS NEEDLE WAS USED TO ACCESS THE ABDOMINAL CAVITY. AFTER THE PATIENT'S ABDOMEN WAS INSUFFLATED WITH APPROXIMATELY 3 L OF CARBON DIOXIDE GAS, THE VERESS NEEDLE WAS REMOVED AND A 12 -MM TROCAR WAS PLACED. THE SURGEON STATED THAT AN EXPLORATION OF THE ABDOMEN AND PELVIS WAS PERFORMED AND NO EVIDENCE OF ANY INJURY AT THE SITE OF ENTRY WAS FOUND. THE PATIENT WAS THEN PLACED IN TRENDELENBURG POSITION. DURING REPOSITIONING, THE PATIENT WAS NOTED TO HAVE INTERMITTENT HYPOTENSION AND HYPERTENSION. HOWEVER, THE SURGEON STATED THAT IT W

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT TWO DAYS AFTER A SUCCESSFUL DA VINCI SI TONGUE BASE RESECTION PROCEDURE AND WHILE STILL ADMITTED, THE PATIENT EXPERIENCED BLEEDING FROM THE OPERATIVE AREA AND EXPIRED. IT WAS REPORTED THAT THE PATIENT DID EXPERIENCE BLEEDING FROM THE LINGUAL ARTERY DURING THE PROCEDURE; HOWEVER, THE BLEEDING WAS CONTROLLED WITH CAUTERY. THE SITE HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION WITHOUT SUCCESS.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI-ASSISTED ROBOTIC CORONARY ARTERY BYPASS GRAFT PROCEDURE FOR CORONARY ARTERY DISEASE ON (B)(6) 2012. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT (S) AND SUBSEQUENT MEDICAL RECORDS INCLUDING AUTOPSY REPORTS. A CAREFUL REVIEW OF THE MEDICAL DOCUMENTATION WAS CONDUCTED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, AND/OR ACCESSORY DURING THE OPERATION. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. THE PATIENT'S IMMEDIATE POST-OP RECOVERY IN THE HOSPITAL WAS EXCELLENT. AFTER THE DA VINCI SURGERY WAS COMPLETED, THE PATIENT PRESENTED WITH THE FOLLOWING: ON (B)(6) 2012, THE PATIENT DEVELOPED FEVER AND SHORTNESS OF BREATH. AN EKG TEST WAS PERFORMED AND THE PATIENT WAS FOUND TO HAVE A RIGHT BUNDLE BRANCH HEART BLOCK. ON (B)(6) 2012, A CARDIAC MRI REVEALED THAT THE PATIENT HAD MYOCARDITIS. THE PATIENT CONTINUED TO BE FEBRILE AND SUBSEQUENTLY BECAME HYPOTENSIVE AND HYPOXIC. ON (B)(6) 2012, THE PATIENT WAS TRANSFERRED TO THE CCU FOR ICU TREATMENT. THAT SAME DAY WHILE IN THE CATH LAB FOR PULMONARY ARTERY (PA) CATHETE

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, RESECTION OF ENDOMETRIOSIS AND CYSTOSCOPY ON (B)(6) 2012. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE (OP) REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED FOLLOW-UP HOSPITAL RECOVERY NOTES: ACCORDING TO THE INFORMATION IN THE PATIENT'S OP REPORT, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2012 THE PATIENT PRESENTED TO THE ER WITH ABDOMINAL PAIN, VAGINAL BLEEDING, AND REPORTS OF FEVER. THE PATIENT WAS GIVEN PACKED RED BLOOD CELLS TRANSFUSION. NOTES FROM THE HOSPITAL REPORT THAT THE PATIENT WAS AFEBRILE ON MULTIPLE DETERMINATIONS. A CT SCAN SHOWED 7/8CM PELVIC FLUID COLLECTION POSSIBLY RESOLVING A HEMATOMA. THE PATIENT'S COMPLETE BLOOD COUNT SHOWED THAT THE PATIENT HAD A NORMAL WHITE BLOOD COUNT AND HEMATOCRIT. THE PATIENT WAS TREATED WITH IV UNASYN DESPITE LACK OF EVIDENCE OF INFECTION OR DOCUMENTED FEVER. THE PATIENT WAS DISCHARGED TO HOME ON PERCOCET AND AUGMENTIN.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A SLEEP NASAL ENDOSCOPY, UVULOPALATOPHARYNGOPLASTY AND TONGUE BASE REDUCTION WITH DA VINCI TRANSORAL ROBOTIC SURGERY (TORS) PROCEDURE ON (B)(6) 2012 FOR SEVERE OBSTRUCTIVE SLEEP APNEA AND CPAP INTOLERANCE. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. PER THE OPERATIVE REPORT, THE PATIENT WAS FOUND TO HAVE PROFOUND LINGUAL TONSIL HYPERPLASIA WHICH LED TO IMMEDIATE UPPER AIRWAY OBSTRUCTION UPON LOW DOSE ADMINISTRATION OF PROPOFOL. TO A LESSER EXTENT, THE PATIENT HAD UVULA AND SOFT PALATAL COLLAPSE. A TOTAL OF 19 ML OF TONGUE BASE WAS REMOVED. AS HEMOSTATIC AGENT WAS BEING APPLIED, BRISK BLEEDING WAS NOTED IN THE LEFT HYPOPHARYNX AND A THROAT PACK WAS PLACED. AFTER ALLOWING ADEQUATE TIME FOR HEMOSTASIS, THE THROAT PACK WAS GRADUALLY ADVANCED OUT OF THE HYPOPHARYNX AND EXPOSURE WAS ACHIEVED WITH A MOUTH GAG AND ROBOTIC CAMERA. THE SURGEON NOTED THAT THE LIKELY SOURCE OF BLEEDING WAS A SMALL BRANCH OF THE LINGUAL AR

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 NERVE SPARING RADICAL HYSTERECTOMY TYPE III, BILATERAL PELVIC LYMPHADENECTOMY, BILATERAL SALPINGECTOMY, BILATERAL OOPHOROPEXY FOR CERVICAL CANCER ON (B)(6) 2012. 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 PATIENT WAS DISCHARGED HOME IN GOOD CONDITION ON (B)(6) 2012. ON (B)(6) 2012 PATIENT PRESENTED WITH SMALL BOWEL PROLAPSING THROUGH THE VAGINA. SHE WAS DIAGNOSED WITH VAGINAL CUFF DEHISCENCE, TAKEN TO THE OPERATING ROOM FOR REPAIR.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT 4 HOURS INTO A DA VINCI S PROSTATECTOMY PROCEDURE, IT WAS NOTED BY THE ANESTHESIOLOGIST THAT THE PATIENT'S HEALTH WAS DECLINING. SEVERAL ATTEMPTS BY THE SURGICAL TEAM WERE MADE TO REVERSE THE PATIENT'S CONDITION, HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL AND THE PATIENT EXPIRED. NO OTHER ADDITIONAL 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, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2012 FOR ADENOCARCINOMA OF THE PROSTATE. ISI 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. VISUALIZATION OF THE INTRA-PERITONEAL CAVITY REVEALED SOME INTRA-ABDOMINAL ADHESIONS IN THE RIGHT UPPER QUADRANT AND IN THE PERIUMBILICAL REGION. SHARP DISSECTION WAS USED TO TAKE DOWN THE OMENTAL ADHESIONS AND A FEW SMALL BOWEL ADHESIONS. INSPECTION OF THE INTESTINES REVEALED NO INJURY. THE PATIENT WAS VERY THIN, SO THE TROCARS WERE PLACED CLOSER TO EACH OTHER THAN NORMAL. A MINIMAL NERVE SPARING PROCEDURE WAS PERFORMED BILATERALLY SECONDARY TO HIS AGGRESSIVE CANCER. OOZING FROM THE DORSAL VENOUS COMPLEX WAS NOTED AND LIGATED WITH SUTURES. GOOD HEMOSTASIS WAS NOTED THROUGHOUT THE PROCEDURE. A BILATERAL LYMPH NODE DISSECTION WAS PERFORMED FROM THE LEVEL OF THE ILIAC VESSELS TO THE OBTURATOR NERVE AND VESSELS POSTERIORLY TO THE PELVIC SIDEWALL, TO THE BLADDER MEDIALLY. NO INJU

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE PATIENT WAS NOT SECURELY VELCROED TO THE OPERATING TABLE, CAUSING THE PATIENT TO SLIDE. THE SYSTEM CAMERA ARM THAT WAS DOCKED TO THE PATIENT WAS ABLE TO HOLD THE PATIENT ON THE TABLE AND PREVENT THEM FROM FULLY SLIDING OFF. DUE TO THE SLIDING, TEARING OCCURRED AT THE TROCAR PORT INCISION LOCATION. THE TEAR WAS REPAIRED AT THE END OF THE SURGICAL PROCEDURE. NO ADDITIONAL PATIENT HARM WAS REPORTED. AFTER THE EVENT OCCURRED, THE SURGEON INDICATED THAT THE CAMERA ARM WAS DIFFICULT TO MOVE AND FELT LIKE IT WAS PULSATING DURING MANUAL MOVEMENT.

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) 2012 FOR AN ENLARGED BOGGY UTERUS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES A HISTORY AND PHYSICAL EXAM FOR WHEN THE PATIENT DEVELOPED VAGINAL BLEEDING AFTER SURGERY. 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 HAD AN UNEVENTFUL OPERATION. ON (B)(6) 2012, THE PATIENT CALLED THE DOCTOR'S OFFICE COMPLAINING OF A FOUL DISCHARGE. SHE BEGAN FLAGYL TREATMENT FOR A VAGINAL INFECTION. ON (B)(6) 2012, THE PATIENT WAS SEEN IN THE DOCTOR'S OFFICE WITH PAIN AND BLEEDING AFTER INTERCOURSE. SHE RETURNED TO OUTPATIENT SURGERY TO HAVE A BROKEN SUTURE REPLACED. THE UPPER VAGINA WAS RE-SUTURED WITH 5 SUTURES OF 1 VICRYL.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER AN UNCOMPLICATED DA VINCI HYSTERECTOMY PROCEDURE WAS SUCCESSFULLY COMPLETED, THE PATIENT EXPIRED LATER THAT NIGHT.

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 ASSISTED MODIFIED RADICAL HYSTERECTOMY AND BILATERAL PARA - AORTIC LYMPHADENECTOMY, THE INSULATING SHEATH ON THE MONOPOLAR SCISSORS MALFUNCTIONED AND LEAKED ELECTRICITY ON TO THE ATHEROSCLEROTIC AORTA. THIS CREATED AN AORTIC TEAR WHICH NECESSITATED CONVERTING TO A LAPAROTOMY AND A VASCULAR SURGEON TO REPAIR THE AORTIC 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 WHO UNDERWENT A DA VINCI SI TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO OOPHORECTOMY AND CYSTOURETHROSCOPY PROCEDURE ON (B)(6) 2012. APPROPRIATE RISKS AND BENEFITS OF THE PROCEDURE WERE DISCUSSED. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT'S PRE-OPERATIVE AND POST-OPERATIVE DIAGNOSES WERE UTERINE FIBROIDS, PELVIC PAIN, MENORRHAGIA AND ANEMIA. THE UTERUS WAS INSPECTED AND FOUND TO BE TOO LARGE TO PASS THROUGH THE CUFF SO THE UTERUS WAS MORCELLATED USING THE GYNECARE DEVICE. THE FIBROIDS WERE TOO DENSE SO THE GYRUS MORCELLATOR WAS USED. THE PELVIS WAS IRRIGATED MULTIPLE TIMES AND MULTIPLE PIECES OF THE UTERUS WERE REMOVED. THE PROCEDURE FINDINGS WERE AN ENLARGED FIBROID UTERUS, BILATERAL OVARIAN CYSTS, AND A UTERUS MEASURING 1075 GRAMS. NO COMPLICATIONS OR MALFUNCTIONS OF THE DA VINCI SI SYSTEM WERE NOTED IN THE OPERATIVE REPORT. APPROXIMATELY 12 DAYS AFTER THE DA VINCI SI SURGICAL PROCEDURE ((B)(6) 2012), THE PATIENT SOUGHT MEDICAL ATTENTION BECAUSE THE PATIENT BEGAN EXPERIENCING UNCONTROLLABLE INCONTINENCE THE DAY PRIOR TO COMING IN. A P

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 AND CYSTOSCOPY FOR MENOMETRORRHAGIA AND ANEMIA ON (B)(6) 2012. 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. THE PATIENT HAD A REMARKABLY LARGE UTERUS, 18-20 IN SIZE. THERE WERE NUMEROUS DENSE ADHESIONS IN THE PELVIS, INCLUDING ADHESIONS TO BLADDER, UTERUS AND OMENTUM. SHARP AND BLUNT DISSECTION WAS USED TO TAKE DOWN THE ADHESIONS. BECAUSE OF THE LARGE SIZE OF THE UTERUS, IT COULD NOT BE REMOVED INITIALLY, SO THE SURGEON ATTEMPTED TO MORCELLATE IT VAGINALLY. THIS WAS UNSUCCESSFUL AFTER TRYING FOR 1.5 HOURS. THIS WAS NOT DONE ROBOTICALLY. AT THIS POINT, THE ROBOT WAS RE-DOCKED AND THE FUNDAL PORTION OF THE UTERUS WAS BIVALVED. IT WAS STILL DIFFICULT TO REMOVE THE UTERUS VAGINALLY BUT EVENTUALLY THE SURGEON WAS SUCCESSFUL. A CYSTOSCOPY WAS PERFORMED WHICH SHOWED GOOD BLADDER INTEGRITY AND GOOD EFFLUX OF DYE BILATERALLY. POSTOPERATIVELY SHE DEVELOPED INCREASING ABDOMINAL PAIN, NAU

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 LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, UTEROSACRAL VAGINAL VAULT SUSPENSION AND CYSTOSCOPY PROCEDURE ON (B)(6) 2012 FOR MENORRHAGIA, DYSMENORRHEA AND PELVIC PAIN. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AS WELL AS A POSTOPERATIVE CONSULT REPORT FROM (B)(6) 2012. MULTIPLE LAB REPORTS WERE ALSO INCLUDED. 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. MULTIPLE ADHESIONS OF THE OMENTUM, SIGMOID, EPIPLOICA AND SIGMOID TO THE LEFT PELVIC SIDEWALL AND OVARY WERE NOTED AND TAKEN DOWN, WHICH TOOK APPROXIMATELY 30 MINUTES. THE REMAINDER OF THE PROCEDURE WAS UNEVENTFUL AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2012, THE PATIENT PRESENTED WITH ABDOMINAL PAIN, NAUSEA, AND VOMITING IN THE ER. SHE WAS HALLUCINATING AND SWEATING PROFUSELY. SHE HAD A TENDER ABDOMEN AND FEVER. THE CT SCAN SHOWED A LARGE ABSCESS IN THE PELVIS AND PNEUMOPERITONEUM WITH EXTREME INFLAMMATORY CHANGE IN THE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A NURSE GOT HER HAND SMASHED BETWEEN THE DA VINCI SI SURGICAL SYSTEM AND THE WALL WHILE SHE WAS DRIVING THE PATIENT SIDE CART. THE NURSE OBTAINED AN X-RAY OF HER HAND TO CONFIRM THAT THERE WAS NO FRACTURE. NO FURTHER HARM 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: ON 26-NOV-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE GENERAL THORACIC AND CARDIOVASCULAR SURGERY ARTICLE TITLED, ¿IS LEFT-SIDE DAVINCI PROCEDURE CHALLENGING? INITIAL EXPERIENCES OF A SINGLE INSTITUTE.¿ WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: CASE #2 INVOLVED A 66-YEAR OLD FEMALE PATIENT WITH STAGE 1A CANCER WHO UNDERWENT A DA VINCI-ASSISTED LEFT UPPER LOBECTOMY PROCEDURE ON AN UNSPECIFIED DATE. THE CAUSE OF THE CONVERSION PER TABLE 3 IN THE ARTICLE WAS AN ¿INJURY OF AORTA.¿ ¿IN CASE 2, THE AORTA WAS PARTIALLY STAPLED UPON DIVIDING THE INTERLOBAR FISSURE BETWEEN THE APICO-POSTERIOR SEGMENT OF THE LEFT UPPER LOBE AND THE APICAL SEGMENT OF THE LEFT LOWER LOBE, WHICH WAS REPAIRED BY END-TO-END ANASTOMOSIS UNDER BYPASSING WITH EXTRACORPOREAL MEMBRANOUS OXYGENATION. IN BOTH CASES CONVENTIONAL ENDOSCOPIC STAPLING DEVICES WERE EMPLOYED.¿ THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED IN RELATION TO THE REPORTED EVENT. FURTHERMORE, IT WAS NOTED IN REFERENCE TO CASE #2 (AND CASE #1), "IN BOTH CASES, CONVENTIONAL ENDOSCOPIC STAPLING DEVICES WERE EMPLOYED." ADDITIONALLY, THE ARTICLE STATES THE FOLLOWING: "WE EXPERIENCED TWO C

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 HYSTERECTOMY WITH BILATERAL SALPINGECTOMY PROCEDURE ON (B)(6) 2011. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD PREOPERATIVE DIAGNOSIS OF A LARGE, SUBSEROSAL UTERINE FIBROID, DYSPAREUNIA, AND MENORRHAGIA. THE RISKS OF SURGERY WERE DISCUSSED WITH THE PATIENT, INCLUDING OPTIONS OF OPEN AND MINIMALLY INVASIVE SURGERY. ACCORDING TO THE OPERATIVE REPORT, THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED INTRA-OPERATIVE COMPLICATIONS. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE SURGEON STATED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ACCORDING TO THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD NORMAL FOLLOW-UP POSTOPERATIVE EXAMINATIONS ON (B)(6) 2012. PHYSICAL EXAM DESCRIBES THE VAGINA AS WELL-SUPPORTED AND COMPLETELY HEALED, WITHOUT ANY MASSES OR GRANULATION TISSUE. NO TENDERNESS WAS ELICITED. ON (B)(6) 2012, THE PATIENT PRESENTED TO HER GYN'S OFFICE AS A FOLLOW-UP FROM AN EMERGENCY ROOM (ER) VISIT THE PREVIOUS NIGHT. THE MEDICAL RECORDS F

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 HYSTERECTOMY PROCEDURE ON (B)(6) 2011. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: HEMORRHAGING AND INFECTIONS. PATIENT CONTINUES TO GET A FISTULA ABOUT EVERY-OTHER MONTH.

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 HYSTERECTOMY PROCEDURE ON (B)(6) 2011 AND ALLEGED TO HAVE INJURIES INCLUDING URETER INJURY, URETEROVAGINAL FISTULA, AND SEPSIS. 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 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 — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2011. THE LEGAL COMPLAINT INDICATES THAT EVENTUALLY, THE ROBOTIC ASSISTANCE WAS COMPLETED AND THE PATIENT WAS RETURNED TO THE TABLE, UPON WHICH TIME THE MORCELLATION PROCESS WAS BEGUN TO REMOVE THE UTERUS, OVARIES, FALLOPIAN TUBES, AND FIBROIDS. THE LEGAL COMPLAINT ALSO INDICATES THAT APPROXIMATELY HALFWAY THROUGH THE MORCELLATION PROCESS, THE PATIENT, HAD NO BLOOD PRESSURE OR PULSE. DUE TO ASYSTOLE, A CODE WAS CALLED AT 2:41 PM. THE PATIENT SUBSEQUENTLY PASSED AWAY AT 2:55 PM THAT SAME DAY. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR THE PATIENT'S MEDICAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. ON (B)(4) 2014, ISI CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR). THE CSR INDICATED THAT HE WAS PRESENT DURING A PORTION OF THE REPORTED DA VINCI SURGICAL PROCEDURE. THE CSR STATED THAT AFTER THE EVENT OCCURRED, HE SPOKE TO THE SURGEON, THE SITE'S CHAIR OF THE ROBOTICS COMMITTEE, THE SITE'S CHAIR OF THE GYN COMMITTEE, AND THE ANESTHESIOLOGI

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

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 — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2011, A PATIENT UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE TOOK 5 HOURS AND 25 MINUTES TO COMPLETE, WITH THE PATIENT IN STEEP TRENDELENBURG POSITION DURING THE CASE. 6-8 HOURS POST-OP, THE PATIENT SUFFERED SUDDEN BILATERAL PNEUMOTHORAX (TENSION) WHICH RENDERED HER COMATOSE AND IN A PERSISTENT VEGETATIVE STATE. LIFE SUPPORT WAS REMOVED ON (B)(6) 2011, AND THE PATIENT EXPIRED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6)2011 AND ALLEGED TO HAVE INJURIES INCLUDING POSTOPERATIVE TRAUMA, CAPILLARY LEAK SYNDROME, SEPSIS, AND DEATH. THE DATE OF DEATH WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SEVERAL DAYS AFTER A SUCCESSFUL DA VINCI SI TONGUE BASE RESECTION (TORS) PROCEDURE AND AFTER BEING DISCHARGED HOME, THE PATIENT EXPERIENCED BLEEDING FROM THE OPERATIVE AREA AND EXPIRED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED; HOWEVER, THE SITE HAS BEEN CONTACTED AND ADDITIONAL INFORMATION IS EXPECTED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI ROBOTIC-ASSISTED LEFT PARTIAL NEPHRECTOMY FOR LEFT RENAL MASS ON (B)(6) 2011. ISI WAS PROVIDED WITH THE OPERATIVE (OP) REPORT AND ALLEGATIONS OF PATIENT COMPLICATIONS. THE PATIENT ALLEGEDLY HAD TO UNDERGO ABDOMINAL EXPLORATION, LEFT COLECTOMY AND DIVERTING LOOP ILEOSTOMY ON (B)(6) 2011, APPROXIMATELY ONE MONTH AFTER HIS ROBOTIC PARTIAL NEPHRECTOMY TO REPAIR PERFORATED LEFT COLON WITH ABSCESS. PRIOR TO THE SECOND SURGERY, THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2011 WITH COMPLAINTS OF ABDOMINAL PAIN ASSOCIATED WITH NAUSEA AND VOMITING. AT THE TIME, HE WAS FOUND TO HAVE PERINEPHRIC ABSCESS WITH POSSIBLE PERFORATION OF THE DESCENDING COLON. FURTHER EVALUATION REVEALED A WIDE BORE FISTULA FROM THE COLON INTO THE ABSCESS CAVITY. THE PATIENT DIED ON (B)(6) 2012 DUE TO ACUTE MYOCARDIAL INFARCTION. PER THE OP REPORT OF (B)(6) 2011, THE PATIENT'S LEFT RENAL MASS WAS FOUND INCIDENTALLY. THE MASS MEASURED 4 CM, LOCATED ON THE POSTEROLATERAL ASPECT OF THE UPPER POLE OF THE KIDNEY. PER THE OP REPORT, ALTERNATIVES, RISKS, AND BENEFITS WERE DISCUSSED WITH THE PATIENT AND

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