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 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 A BLADDER AND BLOOD VESSELS 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) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A JOURNAL ARTICLE BY COOPER ET AL TITLED, UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS. IN THIS ARTICLE, THE AUTHORS REPORTED COMPLICATIONS REPORTED IN MAUDE DATABASE OR LEXISNEXIS, AND PACER (PUBLIC ACCESS TO COURT ELECTRONIC RECORDS) FROM (B)(6) 2000 TO (B)(6) 2012. ACCORDING TO THE ARTICLE, IT WAS REPORTED THAT AN UNSPECIFIED PATIENT INJURY OCCURRED IN RELATION TO DEVICE ASSEMBLY OF AN UNSPECIFIED DA VINCI SURGICAL PROCEDURE PERFORMED ON (B)(6) 2011. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT. THE HOSPITAL NAME, DA VINCI SYSTEM SERIAL, AND TYPE OF PROCEDURE INVOLVED WITH THIS COMPLAINT WERE NOT INCLUDED IN THE ARTICLE. ARTICLE INFORMATION: TITLE: UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS AUTHORS: MICHOL A. COOPER, ANDREW IBRAHIM, HEATHER LYU, MARTIN A. MAKARY PUBLISHED DATE: 08/27/2013 LINK: HTTP://ONLINELIBRARY.WILEY.COM/DOI/10.1111/JHQ.12036/ABSTRACT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON SEPTEMBER 4, 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI NEPHRECTOMY PROCEDURE ON (B)(6) 2011 AND ALLEGED TO HAVE INJURIES TO THEIR KIDNEYS. NO FURTHER INFORMATION IS PROVIDED 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 HYSTERECTOMY 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 VAGINAL ABSCESS.

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, ISI RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI MITRAL VALVE REPAIR PROCEDURE THAT WAS CONVERTED TO ANOTHER TECHNIQUE. THE LEGAL COMPLAINT ALLEGED THAT DURING THE SURGERY THE ROBOTIC ARMS HAD TOO MUCH PRESSURE APPLIED TO THEM CAUSING THE MACHINE TO JOLT. THE LEGAL COMPLAINT ALSO ALLEGED THAT THE PATIENT EXPERIENCED 15 HOURS OF INTERNAL BLEEDING BEFORE DETERMINING THAT EXPLORATORY SURGERY WAS NEEDED, AND THE SURGERY DISCOVERED THAT THE ROBOTIC ARMS SPLICED AND PUNCTURED THE PATIENT'S LIVER AND SPLEEN. DUE TO THE REPORTED INJURIES SUSTAINED BY THE PATIENT DURING THE DA VINCI ROBOTIC SURGICAL PROCEDURE, THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT HAD TO HAVE MULTIPLE ADDITIONAL MEDICAL TESTS AND PHYSICIAN CONSULTATIONS, AND HAD SUFFERED PAIN, LOSS OF FUNCTION, EMOTIONAL DISTRESS, AND PERMANENT INJURY. THE LEGAL COMPLAINT ALLEGED THAT DESPITE ADDITIONAL TREATMENT, THE PATIENT CONTINUED TO SUFFER FROM ABDOMINAL PAIN, FATIGUE, AND DECREASED ENERGY AND STAMINA.

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 #1 INVOLVED A 48-YEAR OLD FEMALE PATIENT WITH STAGE 1B 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 PA¿ (PULMONARY ARTERY).¿IN CASE 1, THE CAUSE OF CONVERSION WAS UNCONTROLLABLE BLEEDING FROM AN INJURY TO THE LINGUAL SEGMENTAL PULMONARY ARTERY DURING STAPLING OF THE INCOMPLETE INTERLOBAR FISSURE.¿ FURTHERMORE, IT WAS NOTED IN REFERENCE TO CASE #1 (AND CASE #2) "IN BOTH CASES, CONVENTIONAL ENDOSCOPIC STAPLING DEVICES WERE EMPLOYED." ADDITIONALLY, THE ARTICLE STATES THE FOLLOWING: "WE EXPERIENCED TWO CONVERSIONS IN STAPLING THE FISSURE OF THE LEFT UPPER LOBE. BOTH CONVERSIONS WERE CAUSED BY FAILURE TO CONFIRM THAT THE TIP OF THE STAPLER WAS FREE FROM THE ADJACENT STRUCTURES. THIS IS PARTLY ATTRIBUTABLE TO THE SPECIFIC CHARACTERISTICS OF THE 30 DEGREE ANGLED SCOPE: IT IS DIFFICULT TO OBSERVE LATERALLY U

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 HYSTERECTOMY PROCEDURE WITH CYSTOSCOPY ON (B)(6) 2010. THE MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD A PREOPERATIVE DIAGNOSIS OF A DYSPAREUNIA, HISTORY OF ENDOMETRIOSIS, POSTCOITAL BLEEDING, AND UTERINE FIBROIDS. ACCORDING TO THE OPERATIVE REPORT, THE RISK AND BENEFITS WERE EXPLAINED AND THE PATIENT AGREED TO UNDERGO THE PROCEDURE. THE DA VINCI SI HYSTERECTOMY PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. AFTER THE UTERUS WAS REMOVED AND THE VAGINAL CUFF WAS CLOSED, GOOD HEMOSTASIS WAS NOTED. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT WAS TAKEN TO THE PACU IN GOOD CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011, AFTER RECEIVING TREATMENT FOR POST-OPERATIVE ACUTE ANEMIA FROM INTRA-ABDOMINAL BLOOD LOSS. AT THE TIME OF DISCHARGE, THE PATIENT WAS TOLERATING A REGULAR DIET, AND PASSING FLATUS WITH NO SIGNS AND SYMPTOMS OF ANEMIA. ON (B)(6) 2011, THE PATIENT WAS EVALUATED IN A HOSPITAL FOR ABD

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 JULY 25TH, 2013 INTUITIVE SURGICAL RECEIVED A LEGAL COMPLAINT INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY WITH PELVIC AND PARAAORTIC LYMPH NODE DISSECTION ON (B)(6) 2010. THE PATIENT HAD A DIAGNOSIS OF GRADE II ENDOMETRIAL CANCER AND FIBROID UTERUS. THE SURGICAL PROCEDURE WAS COMPLETED AS PLANNED WITH THE REMOVAL OF UTERUS, TUBES AND OVARIES THROUGH VAGINA WITH PERIAORTIC LYMPHNODE DISSECTION. THE VAGINAL CUFF WAS CLOSED USING INTERRUPTED STITCHES WITHOUT ANY DIFFICULTY. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS EXTUBATED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010 IN GOOD CONDITION WITH A NORMAL HEMATOCRIT LEVEL WITHOUT COMPLICATIONS AS PER THE MEDICAL RECORDS. AFTER ARRIVING HOME THE PATIENT BEGAN TO DEVELOP NAUSEA AND ABDOMINAL PAIN. THIS PERSISTED TO DEHYDRATION AND SHE PRESENTED TO HOSPITAL'S ER REMARKABLY DEHYDRATED ON (B)(6) 2010. A CT-SCAN PERFORMED SHOWED FINDINGS CONSISTENT WITH A POSSIBLE PELVIC ABSCESS. SHE WAS ADMITTED AND UNDERWENT A CT GUIDED CATHETER PLACEMENT IN AN ATTEMPT TO DRAIN THE ABSCE

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 AND BILATERAL SALPINGO-OOPHORECTOMY AND CYSTOSCOPY ON (B)(6) 2010 FOR MENORRHAGIA. ISI WAS PROVIDED WITH THE 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. DURING A STANDARD HYSTERECTOMY PROCEDURE, EXCELLENT HEMOSTASIS WAS NOTED. PICTURES WERE TAKEN. NO BLADDER PERFORATIONS WERE NOTED AFTER CYSTOSCOPY. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2011, PATIENT UNDERWENT A CYSTOSCOPY, LEFT RETROGRADE PYELOGRAM AND STENT PLACEMENT TO REPAIR A LEFT URETERAL VAGINAL FISTULA. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2011, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN URETEROVAGINAL FISTULA AND UNDERWENT CYSTOSCOPY, BILATERAL RETROGRADE PYELOGRAMS, BOARI FLAP, LEFT URETERONEOCYSTOSTOMY AND INSERTION OF A LEFT URETERAL STENT. A URETEROCELE WAS NOTED IN THE RIGHT URETER AND IT WAS EASILY INTUBATED WITH A CATHETER. THE PREVIOUSLY PLACED LEFT URETERAL ST

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 LEFT OVARIAN CYSTECTOMY WITH EXTENSIVE LYSIS OF ADHESIONS ON (B)(6) 2010. 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. THE PATIENT HAD EXTENSIVE, DENSE, SEVERE ADHESIONS FROM BOWEL TO BOWEL, BOWEL TO ANTERIOR ABDOMINAL WALL, BOWEL TO BLADDER AND TO OVARY. MONOPOLAR AND BIPOLAR ENERGY WERE USED TO LYSE THE ADHESIONS. THE ADHESIOLYSIS TOOK 150 MINUTES. THE PATIENT HAD CHRONIC ABDOMINAL PAIN. ON (B)(6) 2011 PATIENT PRESENTED WITH SEVERE ABDOMINAL PAIN. CT SCAN WAS CONCERNING FOR PERFORATED SMALL BOWEL. THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE SHE WAS FOUND TO HAVE 2 ENTEROTOMIES. ONE WAS FELT TO BE IATROGENIC, OCCURRING DURING THE DISSECTION OF THE OPERATION. THE OTHER WAS FELT TO BE THE CAUSE OF THE LEAK. THE PATIENT UNDERWENT A SMALL BOWEL RESECTION AND ILEOSTOMY. ON (B)(6) 2011 SHE UNDERWENT DELAYED PRIMARY CLOSURE OF HER WOUND. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2011 IN GOOD CONDITION. THE PATIENT UNDERWENT AN ILEOSTOMY TAKEDOWN

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 APPROXIMATELY 2 HOURS DURING A DA VINCI SI RECTOPEXY PROCEDURE, WHILE AN INSTRUMENT CHANGE WAS IN PROGRESS, THE SURGEON REMOVED HIS HANDS FROM THE MASTER TOOL MANIPULATORS (MTM); HOWEVER; LEFT HIS HEAD IN THE SURGEON SIDE STEREO VIEWER. THIS CAUSED THE INSTRUMENT BEING EXCHANGED IN THE GUIDED TOOL CHANGE MODE, TO MOVE SLIGHTLY FORWARD AND BUMP THE PATIENT'S COLON. SLIGHT BLEEDING OF THE PATIENT'S COLON OCCURRED; HOWEVER, NO REPAIR, BLOOD TRANSFUSION OR INTERVENTION WAS NECESSARY. THE PLANNED PROCEDURE WAS COMPLETED AND NO ADVERSE OUTCOME WAS REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON (B)(6) 2013 INTUITIVE SURGICAL RECEIVED A LEGAL COMPLAINT REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON AN UNKNOWN DATE. THE LEGAL COMPLAINT ALLEGES THAT DURING THE SURGICAL PROCEDURE, THE PATIENT SUSTAINED BOWEL PERFORATION. AS A RESULT OF HER BOWEL INJURY THE PATIENT DEVELOPED SEPSIS, EXPERIENCED SEPTIC SHOCK, RENAL FAILURE, HYPOXIC BRAIN INJURY, THYROID INJURY, GALLBLADDER DAMAGE, COGNITIVE DEFICITS, AND URINARY AND BOWEL INCONTINENCE. PER THE INFORMATION IN THE LEGAL COMPLAINT, THE PATIENT HAS SUFFERED SEVERE AND PERMANENT INJURIES INCLUDING SEVERE INTERNAL INJURIES, PAIN, DISABILITY, PHYSICAL IMPAIRMENT, MENTAL IMPAIRMENT, DISFIGUREMENT, MENTAL ANGUISH, INCONVENIENCE AND LOSS OF CAPACITY FOR THE ENJOYMENT OF LIFE, ALL OF WHICH ARE CONTINUING AND ARE PERMANENT IN NATURE. 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: ACCORDING TO ALLEGATIONS MADE IN A LAWSUIT, THE PATIENT EXPERIENCED INTRA-ABDOMINAL BLEEDING, THERMAL BURNING, SEVERE INFECTION WITH INTRA-ABDOMINAL ABSCESSES, AND SEPTIC SHOCK AFTER A DA VINCI HYSTERECTOMY PROCEDURE. THE PATIENT CONTINUES TO SUFFER FROM CHRONIC ABDOMINAL PAIN AND SEVERE BOWEL ISSUES. THE PATIENT HAS BEEN UNABLE TO MAINTAIN INTIMATE RELATIONSHIPS AND SUFFERS EMOTIONAL DISTRESS. ALLEGEDLY, THE PATIENT UNDERWENT MULTIPLE ADDITIONAL MEDICAL TESTS/PROCEDURES AND SURGERY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(6) 2013 INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHOSE BLADDER WAS REPORTEDLY INJURED DURING A DA VINCI SI HYSTERECTOMY AND BILATERAL OOPHORECTOMY ON (B)(6) 2010. THE INADVERTENT DAMAGE TO THE PATIENT'S BLADDER WAS REPAIRED AND THE SURGICAL PROCEDURE WAS COMPLETED. THE OPERATIVE REPORT FOR THE PATIENT'S FOR THE SURGERY DATE OF (B)(6) 2010 INDICATED THAT AN INADVERTENT CYSTOTOMY APPROXIMATELY 2 CM WAS CREATED AND WAS INSTANTLY RECOGNIZED AND REPAIRED WITH SUTURES. INDIGO CARMINE WAS ADMINISTERED TO THE PATIENT AND THERE WAS NO PASSAGE OF DYE INTO THE PERITONEAL CAVITY NOTED AFTER THE COMPLETING THE REPAIR. REPORTEDLY, THE VAGINAL CUFF WAS COMPLETED AND WAS OVERSEWN WITH A GOOD SEAL. HEMOSTASIS WAS CHECKED AND ASSURED. THE PATIENT'S URETERS WERE INSPECTED AND NOTED TO BE IN THEIR NORMAL ANATOMICAL POSITIONS BILATERALLY. THE PROCEDURE WAS COMPLETED A LEAF OF INTERCEED WAS PLACED OVER THE VAGINAL CUFF. THE PATIENT WAS CLOSED, EXTUBATED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO OTHER COMPLICATIONS NOTED. THE PATIENT'S HISTORY AND PHYSICAL REPORT STATED THAT DURING A POST-OP FOLLOW U

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2010. THE PROVIDED INFORMATION ALLEGES THAT THE PATIENT SUSTAINED BLADDER SUTURE AND URETHRAL OBSTRUCTION INJURIES. NO SPECIFIC ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY WAS REPORTED. 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 THAT UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2010. 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 IMPOTENCE AND INCONTINENCE. ACCORDING TO THE INFORMATION PROVIDED IN THE LEGAL COMPLAINT, REPORTEDLY, THE PATIENT UNDERWENT RECONSTRUCTIVE SURGERY TO CONTROL HIS CONTINENCE; HOWEVER, THE SURGERY WAS UNSUCCESSFUL. REPORTEDLY, THE PATIENT HAS SUFFERED CONSTANT PAIN. THE PATIENT ALSO UNDERWENT AN ARTIFICIAL PENILE IMPLANT TO CONTROL HIS IMPOTENCE. REPORTEDLY, THE PROCEDURE FAILED. NO OTHER INFORMATION REGARDING THE PATIENT WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI LAP BAND PROCEDURE ON (B)(6) 2010. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: EXTREME BURNS IN BODY.

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 RECTOPEXY PROCEDURE THE SURGEON EXPERIENCED VISUALIZATION ISSUES DUE THE PATIENT'S EXTREMELY LARGE UTERUS. DUE TO THE POOR VISION, THE SURGEON INADVERTENTLY HIT A VESSEL OVER THE SACRAL PROMONTORY AND UNCONTROLLABLE BLEEDING OCCURRED. AS A RESULT, THE SURGEON CONVERTED TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO MAINTAIN THE BLEEDING AND COMPLETE THE PLANNED PROCEDURE. THE DELAY IN REPORTING IS A RESULT OF THE COMPLAINT HANDLING TEAM MISTAKENLY BELIEVING THAT THE COMPLAINT INFORMATION HAD ALREADY BEEN RECORDED IN THE COMPLAINT DATABASE.

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, INTUITIVE SURGICAL RECEIVED A LEGAL SUMMONS ALLEGING A PATIENT WAS BURNED AND THE SYSTEM TORE TISSUES OF THE PATIENT'S RECTUM, CAUSING A FISTULA WHICH REQUIRED SUBSEQUENT HOSPITALIZATIONS AND MULTIPLE SURGICAL PROCEDURES. IT IS ALLEGED THAT THE PATIENT REMAINS INJURED TODAY AS A RESULT. IT IS ALLEGED THAT THE PATIENT IS PERMANENTLY AND SERIOUSLY INJURED. IT IS ALLEGED THAT THE PATIENT HAS SUFFERED SEVERE PHYSICAL HARM AND SEVERE EMOTIONAL DISTRESS. THE DATE OF THE ORIGINAL PROCEDURE WAS (B)(6) 2010.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT WITH THE FOLLOWING ALLEGATION RELATED TO A DA VINCI SI HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2010: THE LEGAL COMPLAINT ALLEGED THAT ON (B)(6) 2010, THE DA VINCI SURGICAL SYSTEM MALFUNCTIONED, AND AS A RESULT OF THE REPORTED ISSUE, THE PATIENT ALLEGEDLY SUFFERED GRIEVOUS AND PERMANENT PERSONAL INJURIES, PAIN, SUFFERING, AND LOSS OF ENJOYMENT OF LIFE, AGGRAVATION, EXACERBATION AND WORSENING OF PRE-EXISTING CONDITIONS, AND INCURRED PECUNIARY DAMAGES, MEDICAL, HOSPITAL, REHABILITATIVE AND OTHER EXPENSES, AND LOSS OF ABILITY TO WORK.

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) 2010. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISCOVERY ACTIVITY, ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT WAS SCHEDULED TO UNDERGO A DA VINCI MYOMECTOMY 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 DURING PLACEMENT OF A LAPAROSCOPIC DEVICE, UNEXPECTED BLEEDING FROM THE PATIENT OCCURRED. AS A RESULT, THE SURGEON MADE THE DECISION TO PERFORM AN EXPLORATORY LAPAROTOMY TO DETERMINE THE SOURCE OF THE PATIENT'S BLEEDING. A VASCULAR SURGEON WAS CONSULTED. NO ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT A SUCCESSFUL DA VINCI S PROSTATECTOMY PROCEDURE, HOWEVER, ON (B)(6) 2010, THE PATIENT BECAME FEBRILE AND BEGAN EXPERIENCING LOW ABDOMINAL TENDERNESS. ON (B)(6) 2010, THE PATIENT HAD A FEVER AND BLOOD IN HIS STOOL. ON (B)(6) 2010, A CT SCAN REVEALED THAT THE PATIENT HAD POSSIBLY DEVELOPED GENERALIZED PERITONITIS. A RE-OPERATION WAS PERFORMED AND A SIGMOID COLON PERFORATION WAS DISCOVERED. OPEN DRAINAGE WAS PERFORMED AND AN ARTIFICIAL ANUS WAS CREATED. BASED ON THE LAPAROTOMY FINDINGS, THE SYMPTOM SEEMED TO BE DELAYED FISTULATION. THE PATIENT RECOVERED AND WAS DISCHARGED ON (B)(6) 2010.

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) 2010, AND ALLEGED TO HAVE SUSTAINED A URETERAL INJURY. 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: I UNDERWENT ROBOTIC PROSTATE SURGERY AT (B)(6) WITH (B)(6) (NOW AT (B)(6)) ON (B)(6) 2010. OPERATING NOTES SHOWED PERFECT RESULTS. I LATER DISCOVERED USING OUTSIDE UROLOGIST, THAT MY URINARY SPHINCTER HAD BEEN CUT FROM 2 TO 8 O'CLOCK, AND WAS AN OBVIOUS DEFECT WITHOUT ANY HOPE OF RECOVERY. I SUPPLIED (B)(6) WITH THE FINDINGS AND THE UROLOGIST REPORT, WHICH HE RUDELY DISREGARDS AND FAILED TO ACKNOWLEDGE ANY RESPONSIBILITY OR ACCOUNTABILITY. I ASKED HOW THIS OP NOTES SHOWED NO TRACE OF ANY ISSUES, TO WHICH HE MADE DEFLECTIVE STATEMENTS. HIS ACTIONS REFLECT THAT OF GUILT AND COVERING UP ADVERSE EVENTS. I APPROACHED THE HOSP WITH THE SAME RESULTS AS THEY POINTED OUT THAT THE OPERATING NOTES SHOWED NO ISSUES. I AM PROOF THAT THERE WERE ADVERSE RESULTS, BEING DESCRIBED AS UNIVERSALLY INCONTINENT AND IMPOTENT DUE TO ROBOTIC SURGERY. (B)(6) HAS CHOSEN TO COVER UP THE NEGATIVE OUTCOME.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI SURGICAL PROCEDURE ON (B)(6) 2010. 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: ACCORDING TO ALLEGATIONS MADE IN A LAWSUIT, IT WAS REPORTED THAT THE PATIENT SUSTAINED AN INFECTION AND VESICOVAGINAL FISTULA POST A DA VINCI HYSTERECTOMY AND GALL BLADDER PROCEDURE. THE PATIENT CONTINUES TO SUFFER FROM CRAMPING AND BLADDER PROBLEMS. THROUGHOUT THIS TIME PERIOD, THE PATIENT HAS REPORTEDLY BEEN UNABLE TO MAINTAIN NORMAL INTIMATE RELATIONSHIPS AND HAS SUFFERED EMOTIONAL DISTRESS. THE PATIENT HAD TO HAVE ADDED MEDICAL TESTS AND ADDITIONAL SURGERY AND HAS SUFFERED PAIN, LOSS OF FUNCTION, EMOTIONAL DISTRESS, AND PERMANENT 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) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED UF/REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: THE PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY ABOUT THREE YEARS AGO. SHE DEVELOPED A VAGINAL LEAKAGE AND NOTED TO HAVE ON AN INTRAVENOUS PYELOGRAM (IVP) AND A CT SCAN, A HIGH-GRADE OBSTRUCTION IN THE DISTAL LEFT URETER. SHE UNDERWENT A CYSTOSCOPIC EVALUATION, WHICH WAS CONSISTENT WITH A LOW LEVEL INJURY. A NEPHROSTOMY TUBE WAS PLACED. SHE HAD DEVELOPMENT OF A DISTAL FISTULA FORMATION BETWEEN THE URETER AND THE VAGINAL WALL ASSOCIATED WITH 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: IT WAS REPORTED BY THE PATIENT THAT THREE WEEKS POST, A SUCCESSFUL DA VINCI S HYSTERECTOMY PROCEDURE, THE PATIENT WAS READMITTED INTO THE HOSPITAL AND FOUND TO HAVE A SEVERED 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 DURING A DA VINCI SI SACROCOLPOPEXY WITH HYSTERECTOMY PROCEDURE, WHILE THE SURGEON WAS DISSECTING THE I.P. LIGAMENTS AND ROUND LIGAMENTS, THE PATIENTS URETER WAS FOUND TO BE INJURED. A UROLOGIST WAS CALLED INTO THE CASE TO PERFORM A URETEROTOMY AND SUCCESSFUL ANASTOMOSIS OF THE URETER. THE PROCEDURE WAS DELAYED APPROXIMATELY 45 MINUTES FOR THE URETER INJURY REPAIR, HOWEVER THE PLANNED SURGICAL PROCEDURE WAS 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 DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI TOTAL BENIGN HYSTERECTOMY PROCEDURE ON (B)(6) 2010. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA PROSTATECTOMY FOR ADENOCARCINOMA OF THE PROSTATE ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES CONSULTATIONS, PATHOLOGY REPORTS. THERE WAS NOT AN INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY .THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION HOWEVER. DURING THE POSTERIOR DISSECTION OF THE PROSTATE, AN AREA OF ADHERENCE TO THE RECTUM WAS NOTED AND IN CONTINUING WITH THE DISSECTION, A 1CM INADVERTENT ENTRY INTO THE RECTUM WAS NOTED. THE ENTRY WAS CLOSED AND THE PROSTATECTOMY WAS COMPLETED. COLORECTAL SURGERY WAS CONSULTED AND A DECISION TO PERFORM A DIVERTING ILEOSTOMY WAS MADE. THE RECTAL INJURY WAS REPAIRED AND EVALUATED BY COLORECTAL SURGERY AS WELL. THE PATIENT RECOVERED WITH ONLY A TEMPORARY LAPSE IN BOWEL FUNCTION. HE WAS DISCHARGED FROM THE HOSPITAL IN GOOD CONDITION (B)(6) 2010. THE PATIENT HAS INSTRUCTIONS TO SCHEDULE TAKE DOWN OF THE ILEOSTOMY IN 3 MONTHS. NO FURTHER INFORMATION IS AVAILABLE

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 PT WHO UNDERWENT A DA VINCI S PROSTATECTOMY PROCEDURE ON (B)(6) 2010, PROVIDED INTUITIVE SURGICAL INFORMATION REGARDING THEIR POSTSURGICAL EXPERIENCE. THE PT INDICATED THAT THEIR PROCEDURE WAS COMPLETED IN 5.5 HOURS AND THE DAY AFTER SURGERY, THEIR JP DRAIN FILLED WITH URINE AND LEAKING OUTSIDE OF THE CATHETER OCCURRED. THE PT SPENT 6 RECOVERY DAYS IN THE HOSPITAL. THEIR LEAKING CATHETER WAS IN PLACE FOR 5 WEEKS, WITH THE JP DRAIN IN PLACE FOR 5+ WEEKS. THE PT REPORTED THAT THE PROCEDURE LEFT THEM INCONTINENT AND IMPOTENT. THE PT ALSO INDICATED THAT A SECOND SURGERY HAS BEEN PLANNED TO INSTALL AN IUS (INTERNAL URETHRAL SUPPORT). THE PT ALLEGES THAT THEIR SURGERY OUTCOME MAY HAVE BEEN DIFFERENT IF THE PROCEDURE HAD BEEN PERFORMED BY A "QUALIFIED" SURGEON.

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 AUGUST 16, 2013, INTUITIVE SURGICAL, INC.(ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY AND RECTOCELE REPAIR PROCEDURE ON (B)(6) 2010 DUE TO ABNORMAL UTERINE BLEEDING AND UTERINE FIBROIDS. THERE WAS NO ALLEGATION IN THE PATIENT'S OPERATIVE (OP) 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. IT WAS STATED THAT THE PATIENT TOLERATED THE PROCEDURE AND WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. DOCUMENTATION REGARDING THE PATIENT'S POST-OPERATIVE CARE WAS NOT PROVIDED TO ISI. ACCORDING TO THE MEDICAL RECORDS PROVIDED TO ISI, ON (B)(6) 2011 THE PATIENT UNDERWENT ENTEROCEL REPAIR, CYSTOSCOPY, VAGINAL REPAIR DUE TO ACUTE PROLAPSE OF THE INTESTINE THROUGH THE VAGINA. THE PATIENT ALSO UNDERWENT DIAGNOSTIC ARTHROSCOPY AND ABDOMINAL WASHOUT AND FLEXIBLE SIGMOIDOSCOPY DUE TO INTESTINAL EVISCERATION VIA THE VAGINAL CUFF. REPORTEDLY, THE PATIENT TOLERATED THE PROCEDURES WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM WITHOUT COMPLICATIONS. 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY AND LYSIS OF ADHESIONS FOR A HISTORY OF DYSFUNCTIONAL UTERINE BLEEDING AND UTERINE FIBROIDS ON (B)(6) 2012. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT FOR THE PRIMARY SURGERY AND THE FOLLOW-UP HERNIA REPAIR PROCEDURES. REVIEW OF THE PATIENT'S OP REPORT FOUND NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. UPON INITIAL ENTRY, THE PATIENT HAD MULTIPLE DENSE ADHESIONS OF THE OMENTUM TO THE ANTERIOR ABDOMINAL WALL WHICH WERE TAKEN DOWN. THE ROUND LIGAMENTS, UTEROOVARIAN LIGAMENTS AND UTERINE ARTERIES WERE IDENTIFIED, CAUTERIZED AND DIVIDED IN A SEQUENTIAL MANNER. THE BLADDER FLAP WAS DEVELOPED, THE CARDINAL AND UTEROSACRAL LIGAMENTS WERE DISSECTED, AND THE CERVIX CIRCUMSCRIBED AT THE LEVEL OF THE V-CARE UTERINE MANIPULATOR. THE UTERUS WAS DELIVERED THROUGH THE VAGINA AND THE VAGINAL CUFF CLOSED WITH VICRYL SUTURE. EXTENSIVE DISSECTION OF REMAINING ADHESIONS WAS DONE WITH EVICEL FIBRIN SEALANT PLACES OVER THE RAW SURFACES, BUT THE RIGHT OVARY WAS LEFT IN SITU AS IT WAS ADHERED OVE

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 PROSTATECTOMY PROCEDURE ON (B)(6) 2010 FOR ADENOCARCINOMA OF THE PROSTATE. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED HOSPITAL AND OPERATIVE RECORDS THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION, SPECIFICALLY A RECTAL INJURY. THE RECTAL INJURY WAS THOROUGHLY INSPECTED BY THE UROLOGIC SURGEON AND A GENERAL SURGEON AS WELL. THE INJURED AREA WAS SMALL. IT WAS IRRIGATED PRIOR TO AND AFTER REPAIR. THE REPAIR WAS PERFORMED BY THE GENERAL SURGEON IN 3 LAYERS. IT WAS TESTED AND FOUND TO BE AIR AND WATER TIGHT. ANTIBIOTICS HAD BEEN GIVEN PREOPERATIVELY. 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 DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON (B)(6) 2010 FOR UNSPECIFIED REASONS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND A SURGICAL PATHOLOGY REPORT. PROGRESS NOTES FROM (B)(6) 2011 NOTE THE EXISTENCE OF A RECTANGULAR AREA OF 30 X 40CM IN THE SHAPE OF A HEATING PAD THAT MIGHT BE A BURN FROM EXCESSIVE HEATING PAD USE. THIS WAS CIRCLED WITH AN ASTERISK. HER VAGINAL CUFF WAS NOTED TO BE NOT YET COMPLETELY HEALED, BUT LOOKED GOOD. 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 PROCEDURE ITSELF WAS UNREMARKABLE AND GOOD HEMOSTASIS WAS ACHIEVED. ADHESIONS OF THE SIGMOID COLON TO THE LEFT PELVIC SIDEWALL WERE NOTED. SURGICEL WAS PLACED OVER THE VAGINAL CUFF TO ENSURE HEMOSTASIS. THE URETERS WERE INSPECTED AND NOTED TO BE PERISTALSING NICELY AND LATERAL TO THE UTERINE PEDICLES BILATERALLY. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2011, AN OPERATIVE NOTE STATED THAT THE PATIENT PRESENTED WITH PAIN OF 'O

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE PATIENT CLAIMED THAT HE EXPERIENCED THE FOLLOWING POST-OPERATIVE COMPLICATIONS: RIGHT LEG PAIN, INCISIONAL HERNIA THREE MONTHS POST-OPERATIVELY, AND HEMATURIA, INCONTINENCE, AND FREQUENT URGE TO URINATE. ON AN UNSPECIFIED DATE FOUR YEARS POST-OPERATIVELY, THE PATIENT ALLEGED THAT HE DISCOVERED BLOOD IN HIS URINE AND AN INITIAL X-RAY SHOWED THAT HE HAD STONES. WHEN HE FOLLOWED UP WITH A UROLOGIST, THE PATIENT CLAIMED THAT X-RAY FINDINGS REVEALED THAT HE ACTUALLY HAD UNSPECIFIED CLIPS, AND NOT STONES AS INITIALLY REPORTED. ACCORDING TO THE PATIENT, HE UNDERWENT AN UNSPECIFIED CATHETER PROCEDURE TO REMOVE THE CLIPS. HOWEVER, THE SOURCE OF THE CLIPS IS UNKNOWN. IT IS UNKNOWN WHEN, WHERE, AND WHY THE CLIPS WERE INITIALLY PLACED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY HAD OCCURRED DURING THE PROSTATECTOMY PROCEDURE. ON 03/23/2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON'S OFFICE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, THE SURGEON WAS UNWILLING TO RELEASE ANY INFORMATION RELATED TO THE PATIENT OR DA VINCI-ASSI

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 17 HOURS AFTER A DA VINCI S PROSTATECTOMY PROCEDURE WAS SUCCESSFULLY COMPLETED, THE PATIENT'S BLOOD PRESSURE DECREASED AND BLEEDING WAS OBSERVED COMING FROM THE NEUROVASCULAR BUNDLE. A BLOOD TRANSFUSION WAS PERFORMED AND A HEMATOMA EVACUATION WAS CONDUCTED BY OPEN SURGERY. THE SURGEON INDICATED THAT THE SYSTEM FUNCTIONED NORMALLY DURING THE SURGICAL PROCEDURE AND NO ANOMALIES WITH THE SYSTEM WERE NOTICED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI BILATERAL SALPINGO OOPHORECTOMY AND HYSTERECTOMY PROCEDURE ON (B)(6) 2010. THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT SUSTAINED DAMAGE TO HER URETERS AND SUFFERED SEVERE AND PERMANENT INJURIES INCLUDING SEVERE INTERNAL INJURIES. IN ADDITION, THE LEGAL COMPLAINT ALLEGED THAT SHE SUSTAINED PAIN AND SUFFERING, DISABILITY, PHYSICAL IMPAIRMENT, MENTAL IMPAIRMENT, DISFIGUREMENT, MENTAL ANGUISH, INCONVENIENCE AND LOSS OF CAPACITY FOR THE ENJOYMENT OF LIFE, ALL OF WHICH ARE CONTINUING AND ARE PERMANENT IN NATURE. SHE HAS INCURRED MEDICAL AND RELATED EXPENSES AND WILL CONTINUE TO INCUR SUCH EXPENSES IN THE FUTURE. SHE HAS LOST WAGES IN THE PAST AND HAS SUFFERED A LOSS OF EARNING CAPACITY WHICH IS CONTINUING AND PERMANENT IN NATURE.

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 HYSTERECTOMY WITH BILATERAL PELVIC LYMPHADENECTOMY FOR INVASIVE ADENOCARCINOMA OF THE CERVIX ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY SURGERY AND THE FOLLOW UP RECONSTRUCTIVE SURGERIES. NO MEDICAL HISTORY WAS AVAILABLE. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE RADICAL HYSTERECTOMY WAS PERFORMED IN THE STANDARD MANNER WITH SEQUENTIAL CAUTERIZATION AND DIVISION OF THE FALLOPIAN TUBES, UTERO-OVARIAN LIGAMENTS, UTERINE VESSELS, CARDINAL LIGAMENT AND UTEROSACRAL LIGAMENTS. COLPOTOMY WAS PERFORMED WITH ELECTROCAUTERY AND SHARP DIVISION WITH A 2 CM VAGINAL MARGIN. THE SPECIMEN WAS DELIVERED THROUGH THE VAGINA, AND THE VAGINAL CUFF CLOSED WITH V-LOC SUTURE AND ONE ADDITIONAL 2-0 VICRYL SUTURE. LYMPHADENECTOMY WAS PERFORMED FROM THE COMMON ILIAC VESSELS TO THE DEEP CIRCUMFLEX VEIN AND POSTERIORLY TO THE OBTURATOR NERVE. THE URETERS WERE OBSERVED TO BE PERISTALSING NORMALLY, AND THE SURGERY WAS COMPLETED WITHOUT COMPLICATION. ON (B)(6) 201

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON (B)(6) 2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2010 FOR TREATMENT OF CHRONIC PELVIC PAIN AND ABNORMAL UTERINE BLEEDING. THE PATIENT REPORTEDLY HAD A SMALL PERFORATION OF THE BLADDER DURING THE PROCEDURE, WHICH THE SURGEON REPAIRED. THE SURGEON REPAIRED THE BLADDER INJURY BUT ALSO REQUESTED AN INTRAOPERATIVE CONSULT FROM ANOTHER SURGEON TO PERFORM A CYSTOSCOPY TO ENSURE THERE ARE NO OTHER ABNORMALITIES OR INJURIES AND TO ASSESS DRAINAGE FROM THE URETERAL ORIFICES. THE BLADDER WAS FOUND TO BE FULLY DISTENDED AND THERE WAS NO EVIDENCE OF SIGNIFICANT EXTRAVASATION OF URINE OR LEAKAGE. THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION. THE OPERATIVE REPORTS DID NOT CONTAIN ANY REPORT OF A MALFUNCTION OF THE DA VINCI SI SYSTEM, INSTRUMENTS, OR ACCESSORIES THAT CAUSED OR CONTRIBUTED TO THE BLADDER INJURY. TEN DAYS AFTER THE SURGICAL PROCEDURE ((B)(6) 2010), THE PATIENT HAD HER FOLLOWUP APPOINTMENT TO REMOVE THE FOLEY CATHETER. DURING THIS VISIT, SHE HAD COMPLAINTS OF A MALODOROUS VAGINAL 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 DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2010. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS OF URINARY INCONTINENCE AND A HERNIA.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BSO AND CYSTOSCOPY FOR MENORRHAGIA AND OVARIAN CYSTS ON (B)(6) 2010. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL OPERATIVE AND RADIOLOGY REPORTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2010, THE PATIENT PRESENTED TO THE ER COMPLAINING OF ABDOMINAL PAIN. A CT SCAN PERFORMED SHOWED THAT THE PATIENT HAD URETERAL INJURIES. ON (B)(6) 2010, THE PATIENT UNDERWENT A CYSTO FOR POSSIBLE BILATERAL URETERAL INJURY. DIAGNOSIS WA DEFINITE RIGHT URETERAL EXTRAVASATION. THE LEFT SIDE - NO EVIDENCE OF INJURY. BILATERAL STENTS WERE PLACED AT THIS PROCEDURE. ALSO, CT GUIDED DRAINAGE OF INTRA-ABDOMINAL FLUID COLLECTION DURING THIS ADMISSION. THE PATIENT'S MEDICAL RECORDS INDICATED THAT THE PATIENT WAS FOLLOWED OVER THE NEXT SEVERAL MONTHS. ON (B)(6) 2011, THE PATIENT WAS ADMITTED AND AN EXPLORATORY LAPAROTOMY WAS PERFORMED WITH A RIGHT URETERONEOCYSTOSTOMY WITH BOARI

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 HYSTERECTOMY WITH BILATERAL SALPINGO OOPHORECTOMY PROCEDURE ON (B)(6) 2010 FOR ENDOMETRIOSIS AND FIBROIDS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT ALONG WITH ADDITIONAL OPERATIVE REPORTS AND MEDICAL EXAMINATION 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) 2010, THE PATIENT PRESENTED WITH URINARY LEAKAGE. SHE WAS DIAGNOSED WITH A VESICOVAGINAL FISTULA. ON (B)(6) 2010, THE PATIENT UNDERWENT A CYSTOSCOPY FOLLOWED BY AN ABDOMINAL REPAIR OF VESICOVAGINAL FISTULA. THE PATIENT REPORTED PAINFUL INTERCOURSE. NO OTHER RECORDS WERE PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, A PATIENT CONTACTED ISI EMPLOYEE TO REPORT THAT ON (B)(6) 2010, HE HAD A MITRAL VALVE REPAIR SURGERY PERFORMED WITH A DA VINCI S SURGICAL ROBOT SYSTEM AT (B)(6). ACCORDING TO THE INFORMATION STATEMENT PROVIDED BY THE PATIENT, IT WAS INDICATED THAT HE DID NOT FEEL WELL AFTER THE SURGERY, AND HE HAD TO RETURN FOR A SECOND OPEN SURGERY TO REPAIR THREE PROBLEMS, WHICH HE WAS TOLD WERE A RESULT OF THE FIRST DA VINCI PROCEDURE. REPORTEDLY, THE PATIENT WAS INFORMED BY THE SECOND SURGEON WHO PERFORMED THE CORRECTIVE SURGERY THAT THE FIRST DA VINCI ROBOTIC SURGERY PROCEDURE TOOK 90 MINUTES LONGER THAN IT WAS ORIGINALLY PLANNED, AND THAT THE PROBLEMS HE SUFFERED WERE DUE TO ERRORS MADE BY THE FIRST SURGEON. THE PATIENT INDICATED THAT HE STILL HAS ATRIAL FIBRILLATION ISSUES, AND HE IS NOW WEARING A PACEMAKER.

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 NEPHRECTOMY PROCEDURE, THE SURGEON EXPERIENCED VISUALIZATION ISSUES RELATED TO THE PATIENT'S ANATOMY AND AS A RESULT, THE PATIENT'S AORTA WAS INADVERTENTLY DAMAGED AND THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, ON 07/25/2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2010 FOR DYSMENORRHEA, MENORRHAGIA, AND DYSPAREUNIA. ACCORDING TO THE OPERATIVE REPORT FOR THE DA VINCI SI SURGICAL PROCEDURE, THE SURGEON FOUND A RETROVERTED FIBROID UTERUS, NO EVIDENCE OF ENDOMETRIOSIS, AND NORMAL APPEARING OVARIES AND APPENDIX. THE REPORT MENTIONED THE USE OF THE BIPOLAR CAUTERY, AND ENDOSHEARS INSTRUMENTS DURING THE SURGICAL PROCEDURE. THERE WAS NO REPORT OF ANY DA VINCI SYSTEM OR INSTRUMENT MALFUNCTION OCCURRING DURING THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN THE RECOVERY ROOM IN STABLE CONDITION. NO COMPLICATIONS WERE NOTED. THE PATIENT WAS SENT HOME POSTOPERATIVE DAY 2. ON (B)(6) 2010 THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ABDOMINAL PAIN. THE MEDICAL RECORD INDICATED THAT THE PATIENT WAS HAVING SEVERE ABDOMINAL PAIN, NAUSEA, VOMITING, FEVER, AND BLOODY STOOL. A CAT SCAN WAS DONE ON THE PELVIS AND ABDOMEN SHOWING FINDINGS CONSISTENT WITH INFLAMMATORY OR INFECTIOUS PROCESS WITHIN THE POST-SURGICAL SITE WITH FLUID COLLECTIONS

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 HYSTERECTOMY PROCEDURE ON (B)(6) 2010 FOR FIBROIDS WITH MENORRHAGIA AND FAILED PREVIOUS NOVASURE. 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 A REPORT OF AN INTRAOPERATIVE COMPLICATION. THE PROCEDURE WAS UNREMARKABLE. THE BLADDER WAS DENSELY ADHERED TO THE LOWER LINING OF THE UTERINE SEGMENT FROM A PREVIOUS CAESARIAN SECTION. NONETHELESS THE CORRECT PLANE WAS IDENTIFIED AND THE BLADDER DISSECTED SAFELY OFF. THE COLPOTOMY WAS PERFORMED AND THE VAGINA CLOSED UNEVENTFULLY. THE PATIENT WAS AWOKEN AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. SHE WAS DISCHARGED THE FOLLOWING DAY FOR A TOTAL STAY OF 2 DAYS. ON (B)(6) 2010, SHE PRESENTED TO THE ER WITH SEVERE LOWER ABDOMINAL PAIN AND CRAMPING. A CT SCAN REVEALED A LARGE AMOUNT OF STOOL IN HER COLON. ON (B)(6) 2010, SHE PRESENTED WITH PERITONITIS AND ON (B)(6) 2010 UNDERWENT AN EXPLORATORY LAPAROTOMY THAT INCLUDED THE LYSIS OF MULTIPLE BOWEL ADHESIONS, AN ABDOMINAL WASHOUT, THE 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: THE FOLLOWING PATIENT STORY CONCERNING A DA VINCI PROSTATECTOMY PROCEDURE WAS FOUND POSTED ON THE (B)(4): I WAS DIAGNOSED WITH A T1CNXMX GLEASON 6 ADENOCARCINOMA, 2 OF 6 BIOPSIES IN (B)(6) 2010. THOUGHT ROBOTIC SURGERY WOULD BE THE BEST TYPE OF SURGERY AVAILABLE. THE FIRST UROLOGIST BENT OVER BACKWARDS TO SELL THE ROBOTIC SURGERY AND MY WIFE AND I AGREED BASED ON THE FAST HEALING TIME AS ALL OTHER OUTCOMES WOULD BE THE SAME AS OPEN SURGERY. BASED ON MY DIAGNOSIS, I THOUGHT I WOULD HAVE AN EXCELLENT CHANCE OF CURE AND A FAST RECOVERY. DA VINCI WEBSITE AND THE SURGEON ALLUDED TO GREAT EXPECTATIONS, I HAD THE SURGERY IN (B)(6) 2010. OUTCOME WAS ATROCIOUS, URINARY TRACT DAMAGE, UTI, BLADDER AND KIDNEY INFECTION, 12 MONTHS OF PERINEAL PAIN AND PHYSIO TO HELP TREAT IT AND STILL REQUIRE PHYSIO OCCASIONALLY (THE PHYSIO MAN THOUGHT DAMAGE WAS CAUSED BY NERVE DAMAGE RELATED TO POSTURAL ISSUES DURING SURGERY), INCONTINENCE, IMPOTENCE AND AT LASTLY AN INCISIONAL HERNIA FROM A VERY LARGE OVERSIZED PORT ABOVE MY NAVEL (6CM LONG OR 2.5 INCHES) DA VINCI WEBSITE SAYS 1/2 INCH (12MM) PORTS. NOW MY STOMACH LOOKS VERY DISTORTED FROM HAVING A VERY LARGE MESH INSERTED TO REPAIR THE HERNIA AND I NOW SPOR