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 INITIALLY REPORTED THAT DURING A DA VINCI MITRAL VALVE REPAIR PROCEDURE, THE SURGEON ALLEGED THAT ARM 4 ON THE PATIENT SIDE CART (PSC) MOVED ON ITS OWN AND AS A RESULT, THE PATIENT'S HEART WAS PUNCTURED. THE SURGEON WAS ABLE TO REPAIR THE INJURY AND COMPLETE THE SURGICAL PROCEDURE. ON (B)(4) 2015, AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL FIELD SPECIALIST (TFS) PERFORMED A FIELD EVALUATION AT THE SITE AND WAS UNABLE TO REPLICATE THE REPORTED ISSUE WITH ARM 4 ON THE PSC. THE TFS TESTED THE DA VINCI SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. THE TFS FOLLOWED UP WITH THE SITE AND ALSO VERIFIED THAT SUBSEQUENT DA VINCI SURGICAL PROCEDURES HAD BEEN PERFORMED WITH THE DA VINCI SYSTEM AND THERE WERE NO RECURRENCES OF THE ALLEGED ISSUE WITH ARM 4. ON (B)(4) 2015, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. THE CSR INDICATED THAT THE REPORTED EVENT OCCURRED TOWARDS THE BEGINNING OF THE SURGICAL PROCEDURE AFTER THE SURGEON HAD OPENED THE PERICARDIUM WITH A PERMANENT CAUTERY SPATULA INSTRUMENT INSTALLED ON ARM 4. AT THE TIME THE EVENT OCCURRED, THE CSR INDICATED THAT THE PATIENT WAS ON BYPASS AND THEREFORE NO B

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI TORS PROCEDURE, THE PATIENT PASSED A FEW DAYS LATER. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE CSR WAS NOT PRESENT DURING THE SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. ACCORDING TO THE CSR, NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS DURING THE DA VINCI SURGERY. THE CSR INDICATED THAT THE PATIENT PASSED AWAY ON (B)(6) 2015 AND AN AUTOPSY WAS TO BE PERFORMED.

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 ASSISTED MITRAL VALVE PROCEDURE, THE SURGEON EXPERIENCED DOUBLE VISION WITH THE 30 DEGREE ENDOSCOPE. THE INTUITIVE SURGICAL INC. (ISI)TECHNICAL SUPPORT ENGINEER (TSE) PROVIDED TROUBLESHOOTING STEPS INCLUDING ASSISTANCE IN RECALIBRATING A REPLACEMENT 30 DEGREE ENDOSCOPE; HOWEVER, THERE WAS NO CHANGE IN VISION. THE SURGEON DECIDED TO COMPLETE THE PROCEDURE USING TRADITIONAL OPEN SURGICAL TECHNIQUES. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, THE INTERFACE BLOCK WAS DAMAGED AND THE FORCE SENSOR CABLE WAS NON-FUNCTIONAL. IT HAS BEEN REPORTED THAT THE SURGERY HAS BEEN CANCELLED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 2. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INTUITIVE SURGICAL EMPLOYEE WHO INITIALLY REPORTED THE COMPLAINT AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: ON (B)(6) 2015, A PATIENT WITH A BIG, LATE T3/T4 GRADE TUMOR LOCATED IN THE LOWER RECTUM UNDERWENT A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE IN ORDER TO REMOVE THE TUMOR. DURING THE PROCEDURE, A SMALL ANASTOMOTIC LEAK WAS IDENTIFIED AFTER A LEAK TEST WAS PERFORMED. THE SURGEON WAS NOT SURE WHAT CAUSED THE ANASTOMOTIC LEAK. IT WAS INDICATED THAT A NON-ISI STAPLER INSTRUMENT HAD BEEN USED TO CREATE THE ANASTOMOSIS. THE PATIENT'S ABDOMEN WAS CLEANED WITH BETADINE AND A PROTECTIVE ILEOSTOMY WAS PLACED. ANTIBIOTICS WERE ALSO ADMINISTERED. ACCORDING TO THE INITIAL REPORTER, NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. THE INITIAL REPORTER ALSO INDICATED THAT THERE WERE NO ISSUES WITH ANESTHESIA. AFTER THE TUMOR WAS REMOVED AND THE SURGICAL PROCEDURE WAS COMPLETED, THE PATIENT WAS

At approximately 2:15 p.m. on July 7, 2015, Employee #1 was working near a robot. The robot was located within an enclosure. Employee #1 was working on a fixture and attempting to place a part into it. As he worked, the robot struck Employee #1, pinning and killing him.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS MDR RELATES TO ONE OF THREE SIMILAR EVENTS THAT WERE REPORTED TOGETHER. SPECIFICALLY, IT WAS REPORTED THAT 3 DIFFERENT PATIENTS, EACH OF WHOM HAD A DA VINCI HYSTERECTOMY PROCEDURE PERFORMED BY THE SAME SURGEON ON DIFFERENT DAYS WITHIN A 6-WEEK PERIOD, RETURNED TO THE HOSPITAL AN UNSPECIFIED NUMBER OF DAYS POST-OPERATIVELY AND WERE FOUND TO HAVE SUSTAINED POST-OPERATIVE THERMAL BURN INJURIES TO A URETER. ON 08/05/2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGEON STATED THAT ON (B)(6) 2015, HE PERFORMED A MULTI-PORT DA VINCI HYSTERECTOMY PROCEDURE. HE INDICATED THAT NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, THERE WERE NO INTRA-OPERATIVE COMPLICATIONS REPORTED. AT THE END OF THE DA VINCI SURGICAL PROCEDURE, THE SURGEON INDICATED THAT HE HAD PERFORMED A CYSTOSCOPY AND BOTH URETERS WERE FOUND TO BE PULSING NORMALLY. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT CAME BACK TO THE HOSPITAL AND A THERMAL BURN INJURY WAS FOUND ON ONE OF THE URETERS CLOSE TO WHERE THE URETER ENTERS THE BLADDER. A UROLOGIST REPAIRED THE URET

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, THE HSS WAS NON-FUNCTIONAL. THE PROCEDURE HAS BEEN COMPLETED WITH A TRADITIONAL SURGERY TECHNIQUE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE CRASH HAS BEEN DETECTED. THE PROCEDURE HAS BEEN COMPLETED WITH A TRADITIONAL SURGERY TECHNIQUE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, THE ROBOT STAND REFERENCE WAS NON-FUNCTIONAL. THE PROCEDURE HAS BEEN COMPLETED WITH A TRADITIONAL SURGERY TECHNIQUE.

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-ASSISTED PULMONARY LOBECTOMY AND MEDIASTINAL MASS LYMPHADENECTOMY PROCEDURE, A FELLOW SURGEON PUNCTURED THE PATIENT'S AORTA WHICH LED TO AN IMMEDIATE CONVERSION TO OPEN SURGERY. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT THE FELLOW SURGEON WAS SEATED AT THE SURGEON SIDE CONSOLE (SSC) AND POSSIBLY PUNCTURED THE PATIENT'S AORTA WITH A MONOPOLAR CAUTERY INSTRUMENT OR SPATULA INSTRUMENT. ACCORDING TO THE INITIAL REPORTER, THERE WAS NO ALLEGATION FROM THE SITE THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE INITIAL REPORTER ALSO INDICATED THAT AFTER THE CASE WAS CONVERTED TO OPEN SURGERY, A COLECTOMY WAS PERFORMED AND A COLOSTOMY WAS PLACED. IN ADDITION, THE INITIAL REPORTER STATED THAT HE HEARD THAT POSSIBLY THE PATIENT LOST ONE OR BOTH LEGS AS A RESULT OF THE REPORTED EVENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CARDIOTHORACIC PROCEDURE, THE INITIAL REPORTER ALLEGED THAT THE SURGICAL STAFF, SPECIFICALLY A NURSE PRACTITIONER, FRACTURED THE PATIENT'S RIBS AND PUNCTURED A BREAST IMPLANT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, BLEEDING WAS OBSERVED AFTER SUTURATION OF THE VAGINAL STUMP WAS COMPLETED. IN ORDER TO CONTROL THE BLEEDING AND PER THE RECOMMENDATION FROM THE ANESTHETIST, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI HYSTERECTOMY TO OPEN SURGERY. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), THE PATIENT HAD CHRONIC VALVULAR DISEASE. BASED ON ECHOCARDIOGRAM RESULTS, THE ANESTHETIST DETERMINED THAT THE PATIENT COULD ONLY TOLERATE A HEAD-DOWN TILT POSITION OF NO GREATER THAN 10 DEGREES. THE CSR INDICATED THAT OPEN SURGERY WAS NOT AN OPTION. THE SURGEON CHOSE TO PERFORM THE SURGICAL PROCEDURE WITH THE DA VINCI SURGICAL SYSTEM INSTEAD OF TRADITIONAL LAPAROSCOPIC SURGERY. DURING THE DA VINCI SURGERY, AN ASSISTANT DOCTOR MISTAKENLY PIERCED OR PERFORATED THE PATIENT'S UTERUS WHILE INSERTING A MANIPULATOR INSTRUMENT, A NON-ISI DEVICE. DUE TO THE INJURY TO THE UTERUS AND THE LIMITED VISION OF THE SURGICAL FIELD IN RELATION TO THE 10 DEGREE HEAD-DOWN TILT POSITION, THE SURGEON INDICATED THAT THE SURGICAL PROCEDURE BECAME MORE DIFFICULT TO PERFORM. AFTER REMOVING THE UTERUS AND SUTURING THE VAGINAL

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE WAS DETECTED LEADING TO TRAJECTORY ISSUE. THE PROCEDURE HAS BEEN COMPLETED WITH A TRADITIONAL SURGERY TECHNIQUE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, THE SURGEON DETECTED THAT ALL TRAJECTORIES WERE INACCURATE, OF UP TO 1CM COMPARED TO THE PLANNING. AS A CONSEQUENCE, THE ROBOT WAS NOT USED TO PLACE THE SCREWS AND THE ROSA SPINE WAS REMOVED AND REPLACED BY ANOTHER SURGICAL TECHNIQUE. NO ADDITIONAL PATIENT IMPACT WAS REPORTED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SPINE SURGERY, AN INACCURACY ISSUE WAS OBSERVED. DURING THE DRILLING OF 1 SCREWM THE SURGEON NOTICED THAT THE ROBOT ARM WAS "PULLING" THE PATIENT ON THE RIGHT. THE SURGEON IMMEDIATELY RELEASED THE SAFETY SWITCH PEDAL. THE PROCEDURE HAS BEEN COMPLETED WITH A TRADITIONAL SURGERY TECHNIQUE.

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 RISK MANAGEMENT DEPARTMENT OF THE HOSPITAL THAT A PATIENT UNDERWENT A DA VINCI-ASSISTED MITRAL VALVE REPAIR PROCEDURE ON (B)(6) 2015. THE SITE'S RISK MANAGEMENT DEPARTMENT CLAIMED THAT A POST-OPERATIVE MRI OF THE PATIENT'S BRAIN REVEALED HEMORRHAGES POSSIBLY RELATED TO ALLEGED METALLIC FOREIGN BODY EMBOLI. THE SOURCE OF THE ALLEGED METALLIC FOREIGN BODY EMBOLI IS UNKNOWN. ACCORDING TO THE SITE'S RISK MANAGEMENT DEPARTMENT, A COMPARISON OF THE PATIENT'S PRE-SURGICAL AND POST-SURGICAL MRI STUDIES CONFIRMED THAT THE FOREIGN BODIES APPEARED AFTER THE HEART SURGERY WAS PERFORMED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE WAS DETECTED. A COMMUNICATION ERROR HAS BEEN IDENTIFIED. THE PROCEDURE HAS BEEN COMPLETED WITH A TRADITIONAL SURGERY TECHNIQUE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, INACCURACY ISSUE WAS OBSERVED FOR 3 OUT OF 4 TRAJECTORIES, SEVERAL COMMUNICATION FAILURES WERE ALSO OBSERVED. THE PROCEDURE HAS BEEN COMPLETED WITH A TRADITIONAL SURGERY TECHNIQUE.

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) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A MAUDE EVENT REPORT MW5040668 WITH THE FOLLOWING EVENT DESCRIPTION: INJURIES TO MY BLADDER, COLON, BURS, PELVIS, AND MY LUNGS COLLAPSE, LIVER AND SPLEEN. SURGERY WAS PERFORMED AT (B)(6) WITH THE ASSIST OF THE DA VINCI ROBOT. I RECEIVED LAPAROSCOPIC LYSIS OF ADHESIONS, ROBOTIC HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY SURGERY. PERFORMED BY SURGEON (B)(6) ON (B)(6) 2013. TRANSFERRED MY CARE TO (B)(6) STARTED SEEING A DR. (B)(6) GI SPECIALIST WHO RECOMMEND I SEE A COLORECTAL SURGEON BY THE NAME OF (B)(6). SHE PERFORMED MULTIPLE SURGERIES BUT FAIL TO NOTE THE INFORMATION IN THE OPERATIVE REPORT. DR. (B)(6) SCHEDULED ME TO HAVE A COLONOSCOPY PERFORMED ON (B)(6) 2014. MY COLONOSCOPY WAS INCOMPLETE AND I NEVER WAS INFORMED WHY AND SURGERY WAS PERFORMED BUT NEVER MENTION IN THE OPERATIVE REPORT. I REPORTED THIS INFORMATION TO PATIENTS RELATION AND THE MATTER WAS INVESTIGATED. I RECEIVED A LETTER FROM PATIENT'S RELATION STATING DR. (B)(6) WILL NO LONGER BE PRACTICING WITH (B)(6). MY MEDICAL RECORDS WAS BOTCHED TO COVER UP MY INJURIES FROM (B)(6). HAVE HIRED BOTH OF THE SURGEONS. I HAVE PROOF OF EVERYTHING STATED. I ALSO DEVELOP

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 5 MONTHS POST A SUCCESSFUL DA VINCI-ASSISTED MITRAL VALVE PROCEDURE, THE PATIENT PRESENTED WITH MIGRAINE HEADACHES. THE PATIENT'S MITRAL VALVE PROCEDURE WAS PERFORMED TO TREAT SEVERE MITRAL REGURGITATION WITH MILD LEFT VENTRICULAR DYSFUNCTION AND DILATED TRICUSPID ANNULUS. THE MITRAL VALVE REPAIR WAS PERFORMED UTILIZING A 35 FLEXIBLE ANNULOPLASTY BAND AND SUTURE CLOSURE OF THE LEFT ATRIAL APPENDAGE WITH TRICUSPID VALVE REPAIR USING A 25 ANNULOPLASTY BAND WHICH WAS ALSO FLEXIBLE IN NATURE. NO COMPLICATIONS WERE REPORTED DURING THE PROCEDURE OR DURING POST-OPERATIVE CARE. A SERIES OF MEDICAL IMAGES WERE COMPLETED IN RESPONSE TO THE PATIENT'S REPORTED MIGRAINE HEADACHES. X-RAY AND CT IMAGES WERE NEGATIVE. AN MRI OF THE BRAIN SHOWED SMALL FOCI OF LOW SMALL SIGNAL INTENSITY. ACCORDING TO THE RADIOLOGY REPORT, SUCH FOCI ARE MOST COMMONLY DUE TO A MICROHEMORRHAGE, CALCIFICATIONS, CAVERNOMAS OR CAPILLARY TELANGIECTASIA. METALLIC MICROEMBOLI ARE EXCEPTIONALLY RARE CAUSES OF SUCH A SIGNAL.

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 5 MONTHS POST A SUCCESSFUL DA VINCI-ASSISTED MITRAL VALVE PROCEDURE, THE PATIENT PRESENTED WITH DIZZINESS. THE PATIENT'S MITRAL VALVE PROCEDURE WAS PERFORMED TO TREAT MITRAL REGURGITATION. THE MITRAL VALVE REPAIR WAS PERFORMED UTILIZING A 36 SEMI-RIGID ATS ANNULOPLASTY RING WITH SUTURE CLOSURE OF THE LEFT ATRIAL APPENDAGE AND CRYOBLATION OF THE LEFT ATRIUM. NO COMPLICATIONS WERE REPORTED DURING THE PROCEDURE OR DURING POST-OPERATIVE CARE. A SERIES OF MEDICAL IMAGES WERE COMPLETED IN RESPONSE TO THE REPORTED DIZZINESS. AN X-RAY AND CT IMAGES OF THE BRAIN WERE NEGATIVE. MRI BRAIN SHOWED SMALL BLOOMING HYPOINTENSE FOCI. ACCORDING TO THE RADIOLOGY REPORT, THE RADIOLOGIST'S IMPRESSION WAS THAT THESE WERE FOCI OF HEMOSIDERIN WITH DIFFERENTIAL CONSIDERATIONS INCLUDING MILD CEREBRAL AMYLOID ANGIOPATHY, MULTIPLE CAVERNOMAS, OR PRIOR MICROHEMORRHAGES. UPON A SECOND REVIEW OF THE MRI, AFTER THE RADIOLOGIST RECEIVED THE ADDITIONAL PATIENT HISTORY OF MITRAL VALVE SURGERY, THE FOCI WERE DESCRIBED AS SUSPICIOUS FOR METALLIC MICROEMBOLI. CLINICAL LITERATURE SEARCH HAS FOUND THAT BOTH MICROHEMORRHAGE AND METALLIC EMBOLI CAN CAUSE THE BLOOMING HYPOINTENSE FOCI AS I

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 INITIALLY REPORTED THAT AFTER COMPLETION OF A DA VINCI LEFT PARTIAL NEPHRECTOMY PROCEDURE, THE SURGEON ATTEMPTED TO PERFORM A RIGHT COLECTOMY PROCEDURE VIA TRADITIONAL LAPAROSCOPIC SURGERY. DURING THE SURGICAL PROCEDURE, BLEEDING FROM THE LEFT KIDNEY WAS OBSERVED. THE CASE WAS CONVERTED TO OPEN SURGERY IN ORDER TO REMOVE THE ENTIRE KIDNEY. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE CSR, THE PATIENT HAD A PRE-EXISTING LOW INR PRIOR TO UNDERGOING THE SURGICAL PROCEDURES. DURING THE SURGICAL PROCEDURES, THE PATIENT WAS ALSO FOUND TO HAVE UNDIAGNOSED CIRRHOSIS OF THE LIVER. NO MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES WERE REPORTED. AFTER COMPLETING THE LEFT PARTIAL NEPHRECTOMY PROCEDURE WITHOUT ANY COMPLICATIONS, THE DA VINCI PATIENT SIDE CART (PSC) WAS UNDOCKED FROM THE PATIENT. THE PATIENT WAS REPOSITIONED AND THE PSC WAS RE-DOCKED TO THE PATIENT IN ORDER FOR THE SURGEON TO PERFORM THE RIGHT COLECTOMY PROCEDURE USING THE SAME PORTS USED DURING THE LEFT PARTIAL NEPHRECTOMY PROCEDURE. AFTER USING THE DA VINCI SURGICAL

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2010, DR. (B)(6), PREPARED MY ABDOMINAL CAVITY WITH A VERESS NEEDLE TO REMOVE A CANCEROUS PROSTATE USING THE ROBOTIC-ASSISTED DAVINCI SYSTEM. ON (B)(6) 2010, ESCALATING PAIN RESULTED IN EXPLORATORY SURGERY WITH THE DISCOVERY OF ABDOMINAL SEPSIS AND A 20 CM THROUGH AND THROUGH PERFORATION TO MY SMALL INTESTINE. AN 8CM SEGMENT OF BOWEL WAS REMOVED AND A REPLACEMENT OF AN ILEOSTOMY FOLLOWED. ON (B)(6) 2010, SUCCESSFUL REVERSAL WAS PERFORMED. I ASKED THE DOCTOR WHAT HAPPENED. HE CLAIMED HE DID NOT KNOW. FOUR YEARS LATER, TWO UNSUCCESSFUL SCAR REVISIONS AND ONGOING MENTAL AND PHYSICAL HEALTH REHABILITATION, I HAD FINALLY FOUND ONE ANSWER TO MY QUESTIONS; WHAT CAUSED THE INJURY. ON (B)(6) 2014, (B)(6), FOUND THE PERFORATION WAS CONSISTENT WITH INJURIES FROM TROCARS, NOT DA VINCI. THEY DID NOT KNOW WHO INSERTED THE TROCAR. I DO NOT KNOW IF THE INJURY WAS DUE TO INEXPERIENCE, LACK OF ATTENTION, POOR JUDGEMENT OR VERESS NEEDLE FAILURE.

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 CYSTECTOMY WITH AN ILIO CONDUIT AND LYMPH NODE DISSECTION PROCEDURE, THE SURGICAL STAFF ENCOUNTERED A SYSTEM ERROR CODE 252. A SYSTEM ERROR CODE 252 IS A NON-RECOVERABLE FAULT. PRIOR TO CONTACTING A TECHNICAL SERVICE ENGINEER (TSE) FOR ASSISTANCE, THE SURGICAL STAFF RE-STARTED THE DA VINCI SURGICAL SYSTEM. HOWEVER, THE SYSTEM ERROR CODE 252 REAPPEARED. AFTER RESEATING THE BLUE AND ORANGE FIBER CABLES ON THE DA VINCI SURGICAL SYSTEM AND UNPLUGGING THE SCOPE FROM THE VIDEO PROCESSOR (VP), THE SYSTEM POWERED ON WITH NO ISSUES. THE SURGICAL STAFF WAS THEN ABLE TO RE-DOCK THE ROBOT. AN UNSPECIFIED TIME LATER, THE SURGICAL STAFF CONTACTED THE TSE AGAIN AFTER THE SYSTEM ERROR CODE 252 REAPPEARED. AT THAT TIME, THE SURGEON HAD ALREADY MADE THE DECISION TO CONVERT THE DA VINCI CYSTECTOMY PROCEDURE TO OPEN SURGERY. THE TSE ADVISED THE SURGICAL STAFF TO GET A NEW SCOPE AS A PRECAUTION. ON (B)(4) 2015, AN ISI TECHNICAL FIELD SPECIALIST (TFS) PERFORMED A FIELD EVALUATION AT THE SITE. THE TFS RESOLVED THE REPORTED SYSTEM ERROR CODE ISSUE BY REPLACING THE CORE AND VP. THE TFS THEN TESTED THE DA VINCI SURGICAL SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. ON

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) 2015, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE SURGICAL ENDOSCOPY JOURNAL ARTICLE TITLED, ROBOT-ASSISTED LAPAROSCOPY FOR DEEP INFILTRATING ENDOMETRIOSIS: INTERNATIONAL MULTICENTRIC RETROSPECTIVE STUDY (COLLINET, ET AL., 2014). IN THE RESULTS SECTION OF THE JOURNAL ARTICLE, THE FOLLOWING WAS NOTED: IN THE RECTUM GROUP, 79% (37/47) OF THE PATIENTS HAD GASTROINTESTINAL SYMPTOMS COMPARED WITH 21% (10/47) OF THE PATIENTS WHO HAD NO GASTROINTESTINAL DISORDERS (P = 1.4.10-9). THE MAIN COMPLICATIONS EXPERIENCED IN THIS GROUP ARE LISTED IN TABLE 2. A LAPAROTOMY CONVERSION WAS PERFORMED DURING A SEGMENTAL RECTAL RESECTION. TWO RECTAL INJURIES OCCURRED DURING RECTAL SHAVING. THE ONE WAS SUTURED, AND THE OTHER NEEDED A SEGMENTAL RECTAL RESECTION WITHOUT STOMIA. THE PATIENTS HAD NO FISTULAS OR ABSCESSES. THIS GROUP ALSO HAD INCREASED BLOOD LOSS (127.5 ± 293 ML; MEDIAN 30 ML; RANGE 5-2, 300 ML) AND ONE CASE OF SEVERE BLEEDING (2,300 ML) DURING A BOWEL RESECTION, REQUIRING BLOOD TRANSFUSION. IN THE BLADDER GROUP, 55% (11/20) OF THE PATIENTS HAD URINARY SYMPTOMS COMPARED WITH 21% [SIC] (9/20) OF THE PATIENTS WITHOUT URINARY DISORDERS (P=0.27). THE COMPLICATIONS IN THIS GROUP 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: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVE REPORTABLE DEATHS OR MALFUNCTIONS. THESE ALLEGATIONS WERE RECEIVED BY INTUITIVE SURGICAL, INC.(ISI) BETWEEN JANUARY 2, 2015 - MARCH 31, 2015. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2003 - (B)(6) 2014.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT COMPLAINED OF ABDOMINAL PAIN. IT WAS LATER FOUND THAT A PORTION OF THE PATIENT'S BOWEL WAS STUCK TO THE FASCIA. ONE OF THREE POSSIBLE EXPLANATIONS OFFERED BY THE SITE FOR THE ISSUE WAS THAT A PART OF THE PATIENT'S BOWEL COULD HAVE GOTTEN CAUGHT ON THE END OF A CANNULA DURING REMOVAL. ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S ROBOTICS COORDINATOR AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HE STATED THAT NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE ROBOTICS COORDINATOR INDICATED ON POST-OPERATIVE DAY 1, THE PATIENT HAD COMPLAINTS OF ABDOMINAL PAIN WHILE SHE WAS IN THE ICU. THE PATIENT WAS TAKEN BACK TO THE OR. A 2-3MM PORTION OF THE PATIENT'S BOWEL WAS FOUND TO BE STUCK TO THE FASCIA WHERE ONE OF THE CANNULA PORTS WAS LOCATED. AT THE CONCLUSION OF THE DA VINCI HYSTERECTOMY PROCEDURE, THE SURGEON DID NOT CLOSE THE 8MM PORT SITE FASCIA WITH SUTURES. ACCORDING TO THE ROBOTICS COORDINATOR, THE SURGEON ONLY CLOSES THE SKIN OF 8MM PORT SITES. THE ROBOTICS COORDINATOR COULD NOT RECALL WHA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI VENTRAL HERNIA REPAIR PROCEDURE, THE PATIENT HAD TO GO BACK TO THE OR AFTER A BOWEL LEAK WAS FOUND. ACCORDING TO THE INITIAL REPORTER, THE BOWEL LEAK WAS NOT IDENTIFIED DURING THE DA VINCI SURGICAL PROCEDURE. ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER WAS PRESENT DURING THE SURGICAL PROCEDURE. THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. INTRA-OPERATIVELY, THE PATIENT EXPERIENCED SUBQ EMPHYSEMA WHICH THE SURGEON ATTRIBUTED TO A FASCIAL DEFECT THAT WAS CAUSED BY MULTIPLE PORTS BEING TAKEN IN AND OUT DURING THE SURGICAL PROCEDURE. THE PATIENT REPORTEDLY HAD BUBBLING AROUND THE FACE, EYES, FINGERS, AND HANDS. AS A RESULT OF THE EVENT, THE SITE HAS SINCE IMPLEMENTED A PROTOCOL TO MINIMIZE THE CHANCES OF THE SUBQ EMPHYSEMA OCCURRING IN FUTURE CASES. THE INITIAL REPORTER INDICATED THAT THE DA VINCI VENTRAL HERNIA REPAIR PROCEDURE WAS COMPLETED AND THE PATIENT INITIALLY DID WELL POST-OPERATIVELY. DURING THE SURGERY, THE 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: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPOPEXY PROCEDURE, THE SURGICAL STAFF WAS HAVING DIFFICULTY REMOVING INSTRUMENTS FROM ARM 1 ON THE SURGEON SIDE CONSOLE (SSC). THE SURGICAL STAFF WOULD SQUEEZE THE RELEASE TABS ON THE INSTRUMENTS BUT WOULD HAVE DIFFICULTY UNINSTALLING THE INSTRUMENTS FROM THE ARM. EACH TIME THE ISSUE OCCURRED, THE SURGICAL STAFF WAS EVENTUALLY ABLE TO REMOVE THE INSTRUMENT FROM THE ARM. ON (B)(6) 2015, AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL FIELD SPECIALIST (TFS) PERFORMED A FIELD EVALUATION AT THE SITE AND WAS ABLE TO REPLICATE THE REPORTED CUSTOMER COMPLAINT. THE TFS RESOLVED THE REPORTED ISSUE WITH ARM 1 BY SCREWING IN THREE PLUNGER PINS THAT APPEARED TO BE UNSCREWED HALF WAY. THE TFS INSPECTED AND TESTED THE DA VINCI SURGICAL SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. THERE WERE NO REPORTS OF A PATIENT INJURY OR ADVERSE EVENT. ON 08/13/2015, ISI RECEIVED FDA VOLUNTARY REPORT MW5042851 WITH THE FOLLOWING EVENT DESCRIPTION: ARM OF THE DAVINCI MACHINE WOULD NOT RELEASE THE INSTRUMENT. THE ASSISTANT TRIED TO REMOVE THE INSTRUMENT AND THE INSTRUMENT SHIPPED [SIC], CAUSING A SUPERFICIAL LACERATION OF THE LIVER. CAUTERY WAS USED

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, THE CABLE/CONNECTOR WAS NON-FUNCTIONAL AND IT WAS NOT POSSIBLE TO USE THE ROSA SYSTEM. THE PROCEDURE HAS BEEN COMPLETED WITH A TRADITIONAL SURGERY TECHNIQUE.

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-ASSISTED RECTOPEXY PROCEDURE, THE SURGEON NICKED A VEIN WHILE REMOVING AN UNSPECIFIED INSTRUMENT. THE CASE WAS CONVERTED TO OPEN SURGERY IN ORDER TO CONTROL BLEEDING. ACCORDING TO THE INITIAL REPORTER, THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS ALREADY COMPLETED AND THE VESSEL INJURY OCCURRED DURING REMOVAL OF THE INSTRUMENTS. AT THAT POINT, THE CASE WAS CONVERTED TO OPEN SURGERY. THE INITIAL REPORTER WAS NOT PRESENT DURING THE SURGICAL PROCEDURE AND WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER WAS INFORMED OF THE EVENT BY A CIRCULATOR FROM THE SITE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED GYNÉCOLOGIE OBSTÉTRIQUE & FERTILITÉ 43 (2015) JOURNAL ARTICLE TITLED, LAPAROSCOPIE ROBOT-ASSISTÉE POUR ENDOMÉTRIOSE COLORECTALE: MORBIDITÉ DE LA RÉSECTION DIGESTIVE ET DU SHAVING. (C.DIGUISTO ET AL.,). WITHIN THE ARTICLE, IT IS NOTED THAT A PATIENT REPORTEDLY SUSTAINED AN OPERATIVE COMPLICATION WHILE UNDERGOING A DA VINCI® SHAVING LAPAROSCOPY PROCEDURE. IN THE ABSTRACT SECTION OR THE JOURNAL ARTICLE, IT IS NOTED, WE OBSERVED ONE CONVERSION TO LAPAROTOMY IN THE RESECTION GROUP AND ONE CASE OF BLADDER INJURY IN THE SHAVING GROUP.

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) 2015, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE JOURNAL OF ENDOUROLOGY (2015) INTERNET ARTICLE TITLED, EFFECTS OF PREVIOUS HERNIA REPAIR ON EXTRAPERITONEAL ROBOTIC ASSISTED RADICAL PROSTATECTOMY; A MATCHED-PAIR ANALYSE STUDY. (AHMED H. AL-SHAREEF ET AL., 2015). WITHIN THE ARTICLE, A STATEMENT IS NOTED ALLEGING THAT TWO BLADDER INJURIES OCCURRED IN RELATION TO A DA VINCI® RADICAL PROSTATECTOMY PROCEDURE. IN THE ABSTRACT SECTION OF THE JOURNAL ARTICLE, THE FOLLOWING IS STATED, HOWEVER, THERE WERE 2 BLADDER INJURIES WHICH WERE TREATED BY USING V-LOC SUTURE, SIMULTANEOUSLY.

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) 2015, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE ARCHIVIO ITALIANO DI UROLOGIA E ANDROLOGIA (2015; 87, 1) JOURNAL ARTICLE TITLED, COMPARING ROBOTIC, LAPAROSCOPIC AND OPEN CYSTECTOMY: A SYSTEMATIC REVIEW AND META-ANALYSIS. (THOMAS FONSEKA ET AL., 2015). WITHIN THE ARTICLE, A STATEMENT IS NOTED ALLEGING THAT 3 PATIENTS REPORTEDLY EXPERIENCED MAJOR COMPLICATIONS AFTER UNDERGOING A DA VINCI® RADICAL CYSTECTOMY PROCEDURE AND SUBSEQUENTLY PASSED AWAY. IN THE STUDY CHARACTERISTICS SECTION, THE FOLLOWING IS STATED, 8.51% OF PATIENTS UNDERGOING RARC HAD MAJOR COMPLICATIONS WITH 3 DEATHS (0.412%) WITHIN 90 DAYS POST-OPERATIVELY.

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) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A CLINICAL STUDY ARTICLE TITLED, IMPLEMENTATION OF A ROBOTIC SURGICAL PROGRAM IN GYNAECOLOGICAL ONCOLOGY AND COMPARISON WITH PRIOR LAPAROSCOPIC SERIES. (INTERNATIONAL JOURNAL OF SURGICAL ONCOLOGY: VOL. 2015, ARTICLE ID 814315). ACCORDING TO THE ARTICLE, THE AIM OF THE STUDY WAS TO DETERMINE WHETHER ROBOTIC SURGERY DURING THE LEARNING CURVE OF THE TEAM HAS COMPARABLE PARAMETERS OF TIME AND MORBIDITY WHEN COMPARED TO WELL-ESTABLISHED LAPAROSCOPIC APPROACH. WITHIN THE ARTICLE, IT IS STATED, FURTHERMORE, A KNOWN IMMUNOCOMPROMISED PATIENT WHO HAD RH + BPLND PRESENTED WITH A RETROPERITONEAL ABSCESS ON DAY 15 AFTER SURGERY. SHE HAD A PROTRACTED COURSE ORIGINALLY MANAGED WITH ANTIBIOTICS FOLLOWED BY BILATERAL RADIOLOGICAL DRAINAGE AFTER WHICH BOWEL INJURY WAS NOTED IN THE CAECUM AND DESCENDING COLON. THAT LED TO RETURN TO THEATRE FOR A LAPAROSCOPIC ILEOSTOMY. THE PATIENT SUBSEQUENTLY RECOVERED WELL. NO FURTHER DETAILS REGARDING THE PATIENT OR SURGICAL PROCEDURE WERE PROVIDED IN THE ARTICLE.

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 PARTIAL NEPHRECTOMY PROCEDURE, THE ELECTROSURGICAL UNIT (ESU) TURNED ON WHILE THE SURGEON WAS DISSECTING WITH A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. AS A RESULT, THE MCS INSTRUMENT CAUTERIZED AND AN ARTERY RUPTURED. THE SURGEON CLAIMED THAT HIS FEET WERE NOT PRESSING ANY PEDALS ON THE SYSTEM. THE CASE WAS REPORTEDLY CONVERTED TO OPEN SURGERY AND THE PATIENT REQUIRED SEVERAL UNITS OF BLOOD. ON (B)(6) 2015 A CIRCULATOR, WHO WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE, INDICATED THAT THE SURGEON WAS COLD DISSECTING WITH THE MCS INSTRUMENT WHEN ENERGY FIRED WITHOUT ACTIVATION BY THE SURGEON. THE CIRCULATOR STATED THAT AN ILIAC ARTERY RUPTURED AND BLED AS A RESULT OF THE ISSUE. THE CASE WAS CONVERTED TO OPEN SURGERY AND A VASCULAR SPECIALIST WAS CONSULTED. THE ESTIMATED BLOOD LOSS OF THE SURGICAL PROCEDURE WAS 3 LITERS AND THE PATIENT RECEIVED BLOOD PRODUCTS. ON (B)(6) 2015, AN ISI TECHNICAL FIELD SPECIALIST (TFS) CONTACTED THE SITE'S ROBOTICS COORDINATOR. THE TFS INDICATED THAT THE SITE HAD REPLACED THE ESU AS WELL AS A CABLE CONNECTED TO THE ESU. THE ROBOTICS COORDINATOR INFORMED THE TFS THAT THE DA VINCI SURGICAL SYSTEM HAD BEEN IN

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE WAS DETECTED. A COMMUNICATION ERROR HAS BEEN IDENTIFIED. A SURGERY DELAY HAS BEEN REPORTED BETWEEN 30 MINUTES AND 1 HOUR.

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) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY ARTICLE TITLED, ROBOTIC-ASSISTED ABDOMINAL CERCLAGE PLACEMENT DURING PREGNANCY AND ITS CHALLENGES: VIDEO ARTICLE. (MENDERES, ET AL., 2015). WITHIN THE JOURNAL ARTICLE, IT IS STATED THAT, AN INCIDENTAL UTERINE VESSEL INJURY OCCURRED, IN THE SECOND CASE, DURING DEVELOPMENT OF THE AVASCULAR SPACE. THE JOURNAL ARTICLE ALSO STATES, THE HEMOSTASIS WAS IMMEDIATELY ATTAINED BY CLAMPING THE VESSEL WITH THE FENESTRATED GRASPERS. PERMANENT HEMOSTASIS REQUIRED APPLICATION OF THE VASCULAR CLIPS, PROXIMALLY AND DISTALLY ON THE LACERATED ARTERIAL SITE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A BJU INTERNATIONAL (BJUI) JOURNAL ARTICLE TITLED, PERIOPERATIVE AND RENAL FUNCTIONAL OUTCOMES OF ELECTIVE ROBOT-ASSISTED PARTIAL NEPHRECTOMY (RAPN) FOR RENAL TUMOURS WITH HIGH SURGICAL COMPLEXITY. (VOLPE ET AL 903-909). THE OBJECTIVE OF THE STUDY WAS TO EVALUATE THE PERIOPERATIVE, POST-OPERATIVE, AND FUNCTIONAL OUTCOMES OF ROBOT-ASSISTED PARTIAL NEPHRECTOMY RAPN FOR RENAL TUMORS WITH HIGH SURGICAL COMPLEXITY AT A LARGE VOLUME CENTER. PER THE ARTICLE, FROM SEPTEMBER 2006 TO DECEMBER 2012, 185 PATIENTS UNDERWENT RAPN WITH THE DA VINCI SURGICAL SYSTEM AT THE CENTER. WITHIN THE ARTICLE, THE FOLLOWING STATEMENT WAS NOTED, TWO INTRAOPERATIVE COMPLICATIONS OCCURRED (4.5%): ONE INFERIOR VENA CAVAL INJURY AND ONE BLEED FROM THE RENAL BED, WHICH WERE BOTH MANAGED ROBOTICALLY. (903). IN ADDITION, THE ARTICLE STATES, THERE WERE POSTOPERATIVE COMPLICATIONS IN 10 PATIENTS (22.7%), OF WHOM FOUR (9.1%) WERE HIGH CLAVIEN GRADE, INCLUDING TWO BLEEDS THAT REQUIRED PERCUTANEOUS EMBOLIZATION, ONE URINOMA THAT RESOLVED WITH URETERIC STENTING AND ONE BOWEL OCCLUSION MANAGED WITH LAPAROSCOPIC ADHESIOLYSIS.

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 TOWARDS THE END OF A DA VINCI PROSTATECTOMY PROCEDURE, THE SURGEON LOST VISION THROUGH THE RIGHT EYE WHILE LOOKING THROUGH THE HIGH RESOLUTION STEREO VIEW (HRSV) ON THE SURGEON SIDE CONSOLE (SSC). AS A RESULT OF THE VISION ISSUE, THE SURGEON MADE THE DECISION TO CONTINUE WITH THE SURGICAL PROCEDURE IN 2D VISION INSTEAD OF 3D VISION. THE VISION ISSUE OCCURRED PRIOR TO CREATION OF AN ANASTOMOSIS. ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND GATHERED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE SURGEON, THE APPLIED FORCE OF THE INSTRUMENTS WAS DISPROPORTIONED IN 2D VISION AND FORCE FEEDBACK WAS MISSING. AS A RESULT, THE SURGEON CLAIMED THAT TISSUES WERE TORN AND THE TOTAL BLOOD LOSS OF THE SURGICAL PROCEDURE WAS 1500 ML. THE SURGEON INDICATED THAT THE SURGICAL PROCEDURE WAS COMPLETED IN 2D VISION AND THE PATIENT DID NOT EXPERIENCE ANY LONG-LASTING INJURIES. ON (B)(4) 2015, THE ISI TECHNICAL FIELD SPECIALIST (TFS) CONTACTED THE SITE'S BIOMED DEPARTMENT FOR TROUBLESHOOTING. THE SITE'S BIOMED DEPARTMENT RESOLVED THE VISION ISSUE BY CLEANING THE RIGHT EYE LENSE OF THE CAMERA.

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-ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE, THE PATIENT SUSTAINED A SEROSAL TEAR TO THE BOWEL DURING EXTRACTION OF THE UTERUS. A GENERAL SURGEON EVALUATED THE BOWEL INJURY AND RECOMMENDED A SIMPLE 3-0 SILK SUTURE. THE SURGEON REPAIRED THE BOWEL INJURY WITH A RUNNING STITCH. ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. THERE WAS NO CLAIM BY THE SURGEON OR SURGICAL STAFF THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE INITIAL REPORTER SPOKE TO THE SURGEON REGARDING THE REPORTED PATIENT INJURY. ACCORDING TO THE INITIAL REPORTER, THE SURGEON BELIEVES THE INJURY OCCURRED WHILE HE WAS USING AN UNSPECIFIED ENDOWRIST INSTRUMENT TO SWEEP AND RETRACT THE BOWEL IN PREPARATION TO EXTRACT THE UTERUS. THE SURGEON CLAIMED THAT THE RUBBING OF THE INSTRUMENT'S WRIST AGAINST THE BOWEL CAUSED A TEAR. THE SURGEON CLAIMED THAT THE BOWEL TISSUE LIKELY GOT CAUGHT ON THE INSTRUMENT'S WRIST. THE BOWEL INJ

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-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, THE SURGEON INJURED THE PATIENT'S VENA CAVA DURING HILAR DISSECTION. THE PATIENT REPORTEDLY BLED OUT ON THE TABLE AND PASSED AWAY. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI CHOLECYSTECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE POSSIBLY SUSTAINED A POSSIBLE COMMON BILE DUCT INJURY. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR AN UNSPECIFIED REASON. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER WHO WAS PRESENT DURING THE SURGICAL PROCEDURE AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER STATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. HE ALSO INDICATED THAT THERE WERE NO INTRA-OPERATIVE COMPLICATIONS AND THE SURGICAL PROCEDURE WAS COMPLETED. HE WAS UNABLE TO PROVIDE ADDITIONAL DETAILS REGARDING THE PATIENT'S POST-OPERATIVE COMPLICATION OR CURRENT STATUS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED VOLUNTARY REPORT MW5038982 WITH THE FOLLOWING EVENT DESCRIPTION: I RECEIVED A TOTAL HYSTERECTOMY WITH A DA VINCI ROBOT. THE MEASUREMENTS WERE OFF AND I WAS UNDER FOR 11+ HOURS. I WAS TAKEN OFF THE ROBOT AND A REGULAR HYSTERECTOMY WAS PERFORMED. AS A RESULT, I HAVE NUMBNESS AND PAIN IN MY LEFT LEG AND FOOT. I ALSO SUFFERED A ROTATOR CUFF INJURY AND UNDERWENT PHYSICAL THERAPY FOR MY SHOULDER. I STAYED IN THE HOSPITAL FOR 4 NIGHTS AND LOST MORE THAN A THIRD OF MY BLOOD DURING THE SURGERY. RECOVERY WAS STRANGE BECAUSE I HAD MORE PAIN IN MY SHOULDER THAN IN MY INCISION AREAS. MY DOCTOR DID NOT KNOW HOW TO PRESCRIBE MUSCLE RELAXANTS OR PT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A SEEG PROCEDURE IT HAS BEEN REPORTED THAT THE PATIENT EXPERIENCED A SIGNIFICANT FRONTOPARIETAL HEMORRHAGE. A VERY SIGNIFICANT DISCREPANCY WAS NOTICED IN ALL OF THE ELECTRODES, WITH A >5MM INFERIOR ERROR. THIS WAS IRRESPECTIVE OF SIDE. ADDITIONALLY, THE ELECTRODES ON THE RIGHT WERE ALL TOO SHALLOW. WHILE BRAIN SHIFT ON THE POST OP SCAN CAN ACCOUNT FOR SOME OF THE APPARENT ERROR THERE IS NOT QUESTION IT DOES NOT ACCOUNT FOR ALL OF IT, IN PARTICULAR THE PROBLEMS WITH THE MESIAL TEMPORAL ONES. AS A RESULT, WE HAVE A HEMORRHAGE, WHICH OF COURSE MAY OR MAY NOT BE DUE TO THIS, AND MISSED THE HIPPOCAMPUS ON ALL ELECTRODES ON ONE SIDE NECESSITATING A SUBSEQUENT PROCEDURE. THE SURGEON NOTICED THAT HE MISSED THE HIPPOCAMPUS ON ALL ELECTRODES ON ONE SIDE NECESSITATING A SUBSEQUENT PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED SACROCOLPOPEXY WITH HYSTERECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A BOWEL INJURY DURING A FOLLOW-UP APPOINTMENT. ON (B)(6) 2015 AND (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE GYN RESIDENT, WHO ASSISTED THE SURGEON WITH THE DA VINCI SURGICAL PROCEDURE, INFORMED THE CSR OF THE REPORTED EVENT. THERE WERE NO ALLEGATIONS THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, THERE WERE NO REPORTS THAT AN INTRA-OPERATIVE COMPLICATION OCCURRED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. DURING A FOLLOW-UP POST-OP VISIT, THE INITIAL REPORTER INDICATED THAT THE PATIENT DID NOT LOOK RIGHT. THE PATIENT WAS EVALUATED AND A BOWEL PERFORATION WAS IDENTIFIED. THE PATIENT UNDERWENT OPEN SURGERY ON AN UNSPECIFIED DATE TO REPAIR THE BOWEL INJURY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS MDR RELATES TO ONE OF THREE SIMILAR EVENTS THAT WERE REPORTED TOGETHER. SPECIFICALLY, IT WAS REPORTED THAT 3 DIFFERENT PATIENTS, EACH OF WHOM HAD A DA VINCI HYSTERECTOMY PROCEDURE PERFORMED BY THE SAME SURGEON ON DIFFERENT DAYS WITHIN A 6-WEEK PERIOD, RETURNED TO THE HOSPITAL AN UNSPECIFIED NUMBER OF DAYS POST-OPERATIVELY AND WERE FOUND TO HAVE SUSTAINED POST-OPERATIVE THERMAL BURN INJURIES TO A URETER. ON 08/05/2015 AND 08/10/2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGEON INDICATED THAT HE PERFORMED A SINGLE-SITE DA VINCI HYSTERECTOMY ON (B)(6) 2015. HE INDICATED THAT NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, THERE WERE NO INTRA-OPERATIVE COMPLICATIONS REPORTED. AT THE END OF THE DA VINCI SURGICAL PROCEDURE, THE SURGEON INDICATED THAT HE HAD PERFORMED A CYSTOSCOPY AND BOTH URETERS WERE FOUND TO BE PULSING NORMALLY. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT CAME BACK TO THE HOSPITAL AND A THERMAL BURN INJURY WAS FOUND ON ONE OF THE URETERS CLOSE TO WHERE THE URETER ENTERS THE BLADDER. A UROLOGIST REPAIRED

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT CAME BACK TO THE HOSPITAL AND SUBSEQUENTLY PASSED AWAY DUE TO SEPSIS. A PHYSICIAN'S ASSISTANT (PA) FROM THE SITE INDICATED THAT AN AUTOPSY WAS PERFORMED AND THE PATIENT WAS FOUND TO HAVE A BOWEL INJURY. THE PA INDICATED THAT THE BOWEL INJURY MIGHT HAVE OCCURRED DURING INITIAL PORT PLACEMENT OF THE DA VINCI SURGICAL PROCEDURE. THE PA ALSO INDICATED THAT IT WAS THE FIRST TIME THAT THE FELLOW HAD INSERTED A TROCAR. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. HE INDICATED THAT THE SITE UTILIZES AN ETHICON TROCAR DURING CAMERA PORT PLACEMENT AND AN AIRSEAL TROCAR FOR THE ASSIST PORT PLACEMENT. IN ADDITION, THE SITE UTILIZES ISI TROCARS FOR PLACEMENT OF THE PORT FOR THE ROBOTIC INSTRUMENTS AND ARMS. HE DID NOT KNOW WHICH TROCAR MIGHT HAVE POSSIBLY CAUSED THE BOWEL INJURY. ON (B)(6) 2015, ISI ALSO CONTACTED THE ISI CLINICAL TERRITORY ASSOCIATE (CTA) WHO WAS PRESENT DURING A PART OF THE DA VINCI SURGICAL PROCEDURE. ACCORDING TO THE CTA, THE PA WAS PRESENT DURING THE SURGICAL PROCEDURE AND THERE WE