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 UNDERGOING A DA VINCI INCISIONAL HERNIA REPAIR PROCEDURE, THE PATIENT PASSED AWAY. THE INITIAL REPORTER OF THIS COMPLAINT, A RESIDENT, DID NOT KNOW THE DATE OF THE DA VINCI SURGICAL PROCEDURE AND WHAT DATE THE PATIENT PASSED AWAY. THE INITIAL REPORTER EXPLAINED THAT HE WAS INFORMED OF THE PATIENT DEATH BY ANOTHER RESIDENT. THE INITIAL REPORTER DID NOT HAVE THE RESIDENT'S CONTACT INFORMATION.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED BY AN ACCURACY EMPLOYEE, THAT A FIELD SERVICE ENGINEER RECEIVED AN ELECTRICAL SHOCK WHILE SERVICING THE SYSTEM MODULATOR CABINET AT THE POINT OF THE CIRCUIT BREAKER THREE. THE FIELD SERVICE ENGINEER REPORTED BURNS ON HIS FINGERS AT THE POINT OF ENTRY, ALONG WITH HEART PALPITATIONS AND AN "UNUSUAL REACTION OF THE NERVOUS SYSTEM." THERE IS NO REPORT OF SERIOUS INJURY OR DEATH.

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) 2014, INTUITIVE SURGICAL, INC.(ISI) RECEIVED INFORMATION FROM A JOURNAL ARTICLE TITLED, DIVERTICULAR DISEASE COMPLICATED WITH COLOVESICAL FISTULA: LAPAROSCOPIC VERSUS ROBOTIC MANAGEMENT. ACCORDING TO THE REPORTED ARTICLE, ALTHOUGH 1 LEAK OCCURRED IN THE ROB GROUP, THIS PATIENT WAS DIVERTED AND DRAINED AT THE TIME OF THE ORIGINAL OPERATION. THIS PATIENT WAS MANAGED CONSERVATIVELY WITH INTRAVENOUS ANTIBIOTICS. THE PATIENT HAD A LOW OUTPUT COLOCUTANEOUS FISTULA AT THE DRAIN SITE THAT RESOLVED SPONTANEOUSLY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT.

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 HEMICOLECTOMY PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 1. THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT SHE WAS PRESENT DURING PART OF THE DA VINCI SURGICAL PROCEDURE AND THE SURGEON PERFORMED EXTRA CAUTERIZATION ON THE PATIENT'S COLON USING A LAPAROSCOPIC STAPLER INSTRUMENT. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT SHE WAS PRESENT DURING THE FIRST HALF OF THE DA VINCI SURGICAL PROCEDURE AND THE CASE WENT WELL. ON POST-OPERATIVE DAY 1, THE PATIENT PRESENTED WITH SYMPTOMS OF AN ANASTOMOTIC LEAK. AT AN UNSPECIFIED TIME THAT SAME DAY, THE PATIENT CODED AND WAS THEN STABILIZED. LATER, THAT SAME DAY, THE PATIENT CODED AGAIN AND THEN SUBSEQUENTLY PASSED AWAY. THE INITIAL REPORTER STATED THAT THE SURGEON DID NOT USE A STAPLER INSTRUMENT MANUFACTURED BY ISI. SHE STATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. THE INITIAL REPORTER SPOKE TO THE SURGEON REGARDING THE REPORTED EVENT AND WAS INFORMED THAT TH

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT 10 DAYS POST A DA VINCI COLORECTAL PROCEDURE ON (B)(6) 2014, THE PATIENT RETURNED TO THE HOSPITAL PRESENTING SYMPTOMS OF A LEAK. IT WAS DISCOVERED THAT THE PATIENT HAD A MINOR LEAK AND UNDERWENT A LAPAROSCOPIC PROCEDURE TO REPAIR THE DEFECT. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR, HE WAS PRESENT DURING THE SURGICAL PROCEDURE. THE CSR INDICATED THAT THE CASE WENT WELL AND NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. THE CSR INDICATED THAT HE WAS TOLD BY THE SURGEON THAT THE PATIENT HAD POSSIBLY DEVELOPED A HEMATOMA AT THE LEAK SITE. 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: IT WAS REPORTED THAT TOWARDS THE END OF DA VINCI GASTRIC SLEEVE WITH HIATAL HERNIA PROCEDURE, THE SURGEON OBSERVED THAT THE PATIENT HAD A LIVER LACERATION. USING A LAPAROSCOPIC CAUTERY INSTRUMENT, THE SURGEON WAS ABLE TO STOP THE BLEEDING FROM THE DEFECT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM WAS REPORTED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR, SHE WAS PRESENT DURING THE ENTIRE PROCEDURE. THE CSR, SURGEON AND PATIENT SIDE ASSISTANT DID NOT OBSERVE WHEN THE DEFECT TO THE PATIENT'S LIVER OCCURRED. THE CSR INDICATED THAT THE SURGEON WAS ABLE TO CONTROL THE BLEEDING EXPERIENCED BY THE PATIENT USING A TRADITIONAL LAPAROSCOPIC HOOK INSTRUMENT. AFTER DISCUSSING THE ISSUE WITH THE SURGEON, THE SURGEON INDICATED TO HER THAT THE INJURY MAY HAVE OCCURRED WHEN THE PATIENT SIDE ASSISTANT INTRODUCED A LAPAROSCOPIC STAPLER INSTRUMENT THROUGH AN ASSIST PORT SITE; HOWEVER, HE WAS UNABLE TO CONFIRM THIS. ACCORDING TO THE CSR, THE PATIENT DID WELL AND DID NOT REQUIRE A BLOOD TRANSFUSION. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM INSTR

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT'S BLADDER WAS INJURED. THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT SHE WAS INFORMED OF THE EVENT BY THE SURGEON IN PASSING THROUGH A HALLWAY. NO OTHER 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, THE HEAD HOLDER ADAPTOR WAS JAMED AND THE SUPPORT ARM ADAPTOR WAS NON-FUNCTIONAL. IT HAS BEEN REPORTED THAT THE SURGERY HAS BEEN CANCELLED

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 THE DEVICE WAS USED TO PERFORM A BIOPSY. ACCORDING TO THE INFORMATION RECEIVED FROM THE DEVICE ITSELF DURING THE SURGERY, THE PROCEDURE WENT WELL AND NO ISSUE WAS NOTICED. THE BIOPSY NEEDLE WAS SUPPOSED TO COLLECT TUMOR CELLS. HOWEVER, THE LAB CONFIRMED NEGATIVE RESULTS EVEN IF THE RMI WAS CONFIRMING THE CORRECT POSITIONING OF THE BIOPSY NEEDLE. A REQUEST WAS MADE BY THE SURGEON TO UNDERSTAND WHAT HAPPENED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI GYN PROCEDURE ON AN UNSPECIFIED DATE, IT WAS DISCOVERED THAT THE PATIENT SUSTAINED AN INJURY TO HER URETER. THE PATIENT UNDERWENT CORRECTIVE SURGERY TO HAVE THE DAMAGE TO HER URETER REPAIRED. 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: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI NEPHRECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A BURN HOLE IN THE BOWEL DURING A RETURN VISIT. THERE WERE NO REPORTS OF AN INCIDENT OCCURRING DURING THE DA VINCI SURGICAL PROCEDURE. THE SITE'S QUALITY DEPARTMENT CLAIMED THAT A FENESTRATED BIPOLAR FORCEPS INSTRUMENT MAY HAVE CAUSED THE PATIENT'S BOWEL INJURY. THE SITE INDICATED THAT DURING THE SURGICAL PROCEDURE, THE ONLY INSTRUMENTS USED WERE A BIPOLAR FORCEPS INSTRUMENT AND A PERMANENT CAUTERY HOOK INSTRUMENT. IN RELATION TO THE REPORTED EVENT, ON 08/14/2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: THE PATIENT UNDERWENT A ROBOTIC ASSISTED LAPAROSCOPIC RADICAL NEPHRECTOMY, LEFT ADRENALECTOMY, AND REPAIR OF SPLENIC CAPSULAR TEAR. THE PATIENT RETURNED TO THE OPERATIVE ROOM (OR) ONE WEEK LATER FOR EXPLORATORY LAPAROTOMY AND HAS A COLON INJURY. THE OPERATING SURGEON BELIEVES THIS MAY BE A THERMAL BURN FROM THE PRIOR SURGERY; LIKELY FAILURE OF INSULATION ON THE CANNULA. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: (B)(6) 2014 ROBOTIC ASSISTED LAPAROSCOPIC RADICAL NEPHRECTOMY, LEFT ADRENALECTOMY, AND REPAIR OF SPLENIC CAPSULAR TE

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 2 DAYS POST A DA VINCI PROSTATECTOMY PROCEDURE, DURING THE PATIENT'S HOSPITAL RECOVERY, IT WAS DISCOVERED THAT THE PATIENT HAD A BOWEL INJURY. THE PATIENT UNDERWENT A SURGICAL PROCEDURE FOR REPAIR OF THE BOWEL DEFECT; HOWEVER, THE PATIENT EXPIRED. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT, SHE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE AND THAT SHE WAS MADE AWARE OF THE REPORTED INCIDENT BY THE SITE'S GENERAL SURGEON. SHE WAS UNABLE TO PROVIDE ANY OTHER INFORMATION REGARDING 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 PARTIAL NEPHRECTOMY PROCEDURE, THE PATIENT'S COLON WAS PERFORATED. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT, SHE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE AND SHE WAS MADE AWARE OF THE REPORTED INCIDENT BY THE SITE'S GENERAL SURGEON. SHE WAS UNABLE TO PROVIDE ANY OTHER INFORMATION REGARDING 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 CHOLECYSTECTOMY PROCEDURE, THE PATIENT'S COMMON BILE DUCT WAS INJURED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR, SHE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. HOWEVER, SHE WAS TOLD BY THE SURGEON AND ROBOTICS COORDINATOR THAT DURING THE SURGICAL PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS DUE TO A COMMON BILE DUCT INJURY AND THE SURGEON MADE THE DECISION TO REPAIR AND COMPLETE THE PROCEDURE USING OPEN SURGICAL TECHNIQUES. THE CSR WAS UNABLE TO PROVIDE ANY OTHER DETAILS REGARDING THE REPORTED EVENT. ON (B)(4) 2014, ISI CONTACTED THE SITE'S ROBOTICS COORDINATOR TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE ROBOTICS COORDINATOR, IT WAS INITIALLY BELIEVED THAT THE PATIENT'S BILE DUCT WAS SEVERED; HOWEVER, A CHOLANGIOGRAPHY WAS PERFORMED AND IT SHOWED THAT THE PATIENT'S COMMON BILE DUCT WAS NICKED. ON (B)(4) 2014, ISI CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. ACCORDING TO THE SURGEON, THE DEFECT TO THE PATIENT'S COMMON BILE DUCT WAS OBSERVED IMMEDIATELY. THE NEXT DAY THE PATIENT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) REVIEWED A JOURNAL ARTICLE TITLED, ROBOT-ASSISTED LEVEL II-IV NECK DISSECTION THROUGH A MODIFIED FACELIFT INCISION: INITIAL NORTH AMERICAN EXPERIENCE. THIS ARTICLE COMES FROM THE INTERNATIONAL JOURNAL OF MEDICAL ROBOTICS AND COMPUTER ASSISTED SURGERY. INT J MED ROBOTICS COMPUT ASSIST SURG (2014). ACCORDING TO THE REPORTED ARTICLE, THE ONLY COMPLICATION ENCOUNTERED DURING ANY OF THE ANALYZED NECK DISSECTIONS WAS AN INJURY TO THE INTERNAL JUGULAR DURING ONE OF THE ROBOT-ASSISTED NECK DISSECTIONS,WHICH WAS REPAIRED AT THE TIME OF DAMAGE WITH SUTURE. THE HOSPITAL NAME AND DA VINCI SYSTEM SERIAL NUMBER INVOLVED WITH THIS COMPLAINT WERE NOT INCLUDED IN THIS 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: ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A JOURNAL ARTICLE TITLED, COMPLETELY ABDOMINAL INTERSPHINCTERIC RESECTION FOR LOWER RECTAL CANCER: FEASIBILITY AND COMPARISON OF ROBOT-ASSISTED AND OPEN SURGERY. THIS ARTICLE IS FROM ENDOSCOPY SURGICAL AND OTHER INTERVENTIONAL TECHNIQUES. ARTICLE WAS PUBLISHED ON 02 APRIL 2014. ACCORDING TO THE REPORTED ARTICLE, FIVE PATIENTS AND ONE PATIENT, RESPECTIVELY, IN THE OPEN AND THE RA GROUP WITH PRESACRAL BLEEDING, AND ONE INADVERTENT INJURY AT THE DISTAL RECTUM DURING ISR IN THE RA GROUP. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENTS. THE DA VINCI SYSTEM SERIAL NUMBER INVOLVED WITH EACH SURGICAL PROCEDURE WAS NOT INCLUDED IN THIS 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: ON MAY 30, 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A JOURNAL ARTICLE TITLED,THE NEPHROMETRY SCORE: IS IT EFFECTIVE FOR PREDICTING PERIOPERATIVE OUTCOME DURING ROBOT-ASSISTED PARTIAL NEPHRECTOMY? THIS ARTICLE IS FROM KOREAN JOURNAL OF UROLOGY, PUBLISHED IN 2014. ACCORDING TO THE REPORTED ARTICLE, PERIOPERATIVE COMPLICATIONS OCCURRED IN 16 PATIENTS, INCLUDING 6 PERIRENAL ORGAN INJURIES, 2 OPEN CONVERSIONS, 3 WOUND COMPLICATIONS, AND 3 GROSS HEMATURIA CASES. ORGAN INJURY CASES CONSISTED OF TWO RENAL VEIN LACERATIONS, TWO SPLEEN INJURIES, AND ONE LIVER AND COLON INJURY. TWO OPEN CONVERSIONS WERE DETERMINED OWING TO DIFFICULTY IN APPROACHING THE ISOLATED RENAL TUMOR AND A TOO SMALL PERITONEAL CAVITY FOR ROBOT CONTROL, RESPECTIVELY. POSTOPERATIVELY, THERE WERE THREE HEMATURIA AND TRANSFUSION CASES, ONE WOUND PROBLEM, ONE ILEUS, AND ONE MINOR PROBLEM RANKED AS CLAVIEN GRADE I OR II. THE MAJOR POSTOPERATIVE COMPLICATIONS CLASSIFIED AS CLAVIEN GRADE III WERE TWO OTHER WOUND PROBLEMS THAT NEEDED REPAIRING AND ONE CASE OF ABDOMINAL FLUID COLLECTION THAT REQUIRED PERCUTANEOUS DRAINAGE. UNIVARIATE AND MULTIVARIATE ANALYSES REVEALED THAT NO PARAMETER HAD A SIGNIFICANT CORRELATION WITH PERI

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 A PATIENT UNDERWENT A DA VINCI LOBECTOMY PROCEDURE AND THE CASE WAS CONVERTED TO OPEN DUE TO BLEEDING. AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) SPOKE TO THE SURGEON AND WAS INFORMED THAT THE PATIENT DID NOT TOLERATE THE PROCEDURE WELL AND DIED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE 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 POST A DA VINCI LOW ANTERIOR RESECTION (LAR) PROCEDURE PERFORMED ON (B)(6) 2014, THE PATIENT PRESENTED SYMPTOMS OF AN ANASTOMOTIC LEAK ON (B)(6) 2014, REQUIRING THE PATIENT TO UNDERGO A SURGICAL PROCEDURE TO REPAIR THE LEAK AND A COLOSTOMY. DURING THE SURGICAL PROCEDURE, THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEERING (TSE) DUE TO EXPERIENCING ARTICULATION ISSUES WITH THE PATIENT SIDE MANIPULATOR (PSM) ARM 1. THE SITE TOLD THE TSE THAT THEY RESEATED THE STERILE ADAPTER SEVERAL TIMES, BUT DID NOT REPLACE THE DRAPE. THEY ALSO INSTALLED OTHER INSTRUMENTS; HOWEVER THE ISSUE PERSISTED. WITH THE ASSISTANCE OF THE TSE, THE SITE STOWED PSM 1 AND COMPLETED THE PLANNED PROCEDURE USING PSM 2 AND PSM 3. AFTER SOME TIME, THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE SURGICAL PROCEDURE, CALLED BACK ISI TSE AND REPORTED THAT WHEN SHE CLUTCHED AND MOVED PSM 1, IT BARELY MOVED. ON (B)(6) 2014, A FIELD INVESTIGATION WAS PERFORMED BY THE ISI FIELD SERVICE ENGINEER (FSE). THE FSE WAS ABLE TO REPLICATE THE ISSUE WITH THE PSM EXPERIENCED BY THE SITE. DURING FUNCTIONAL TESTING, AFTER PERFORMING AN EMERGENCY-STOP AND FAULT OVERR

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: KIDNEY CYST RESECTION WITH DA VINCI ROBOTIC DEVICE AT VIA (B)(6). SURGEON INADVERTENTLY AVULSED A VEIN OR ARTERY WHICH CAUSED MASSIVE BLEED AND PRESSURE DROPS. SURGEON BEGAN USING THE ROBOT'S STAPLING DEVICE TO CONTROL THE BLEED. DURING ONE OF THOSE ATTEMPTS, A STAPLE WAS INADVERTENTLY PLACED ACROSS THE PATIENT'S ABDOMINAL AORTA. UNFORTUNATELY THIS WAS NOT DISCOVERED UNTIL AFTER THE SURGERY SEVERAL HOURS LATER. ONCE IT WAS DETERMINED THAT THE PATIENT HAD NO BLOOD FLOW BELOW HER ABDOMINAL AORTA, SHE WAS TAKEN BACK TO SURGERY WITH A VASCULAR SURGEON. THAT SURGEON REMOVED THE STAPLED PART OF THE AORTA AND CREATED A BYPASS. UNFORTUNATELY THE PATIENT HAD RECEIVED SO MANY UNITS OF BLOOD SHE WAS UNABLE TO CLOT AND DEVELOPED A COAGULOPATHY WHICH LED TO HER DEATH ON THE SURGERY TABLE.

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 PARTIAL NEPHRECTOMY PROCEDURE, THE SURGEON ENCOUNTERED HEAVY BLEEDING FROM THE PATIENT AND DUE TO THE EXTENSIVE BLEEDING EXPERIENCED BY THE PATIENT THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO OPEN SURGICAL TECHNIQUES. LATER THAT NIGHT, THE PATIENT WAS TAKEN BACK INTO THE OPERATING ROOM (OR) AND A VASCULAR SURGEON WAS CONSULTED. ACCORDING TO THE SURGEON IT IS THE HOSPITAL'S BELIEF THAT THE PATIENT'S AORTA HAD BEEN NEARLY STAPLED ACROSS. THE PATIENT EXPIRED IN THE OR. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT REGARDING THE REPORTED EVENT. ACCORDING TO THE SITE'S RISK MANAGER, THE HOSPITAL'S INVESTIGATION IS ONGOING; HOWEVER, THEIR INVESTIGATION THUS FAR HAS DETERMINED THAT THE INTRA-OPERATIVE BLEEDING EXPERIENCED BY THE PATIENT AND FINAL PATIENT OUTCOME WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. THE RISK MANAGER INDICATED THAT THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES DURING THE PLANNED SURGICAL PROCEDURE. THE RISK MANAGER INDICATED THAT HE WAS UNABLE TO PROVIDE ANY OTHER DETAILS REGARDING 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 UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE PATIENT'S VAGINAL CUFF AND AN UNSPECIFIED VEIN ALLEGEDLY TORE OPEN ON POST-OPERATIVE DAY 18. DUE TO ALLEGEDLY LOSING SIGNIFICANT BLOOD, THE PATIENT INDICATED THAT SHE RECEIVED DAILY TRANSFUSIONS FOR SEVEN STRAIGHT DAYS. AS A RESULT OF THE POST-OPERATIVE COMPLICATIONS, THE PATIENT CLAIMED THAT SHE HAS SUFFERED FROM MENTAL HEALTH CHALLENGES. IN RELATION TO THE REPORTED EVENT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5070734 ON 07/14/2017 WITH THE FOLLOWING EVENT DESCRIPTION: STATUTE OF LIMITATIONS ENDS FRIDAY (B)(6) 2017. PLEASE HELP! (B)(6) ATTORNEY (B)(6) HAS BEEN LOOKING ALL OVER THE COUNTRY FOR AN OPEN CLASS ACTION LAWSUIT OR SOMEONE WHO HAS DONE SUFFICIENT RESEARCH ON THE DA VINCI ROBOT TO HELP. I HAD A HYSTERECTOMY USING THE DA VINCI ROBOT ON (B)(6) 2014. ON (B)(6) 2014, THE VAGINAL CUFF TORE OPEN, ALONG WITH A VEIN. I LOST SIGNIFICANT BLOOD. SO MUCH THAT ONE OF THE TRAUMA NURSES AND MY MOTHER HAD ME SIGN A STATEMENT SAYING WHO WOULD GET MY DAUGHTER AND WITNESSED IT. THE NURSE WHO WITNESSED MY SIGNATURE, (B)(6), TOLD ME LATER THAT SHE WAS SHOCKED TO SEE ME ALIVE. IN ALL H

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO ALLEGEDLY SUSTAINED AN INJURY DURING A DA VINCI HYSTERECTOMY AT AN UNSPECIFIED HOSPITAL AND SUBSEQUENTLY EXPIRED ON AN UNKNOWN DATE. NO OTHER INFORMATION REGARDING THE REPORTED ALLEGATION 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: I HAD A HYSTERECTOMY WITH THE DA VINCI SURGICAL ASSISTANT AND MY DUODENUM WAS PUNCTURED RESULTING IN A PELVIC 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: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVE DEATHS. THESE ALLEGATIONS WERE FIRST RECEIVED BY INTUITIVE SURGICAL DURING THE TIME PERIOD OF (B)(6) 2013 TO (B)(6) 2014. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2013.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT EXPERIENCED AN ANASTOMOTIC LEAK. NO OTHER INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED EXTRA FASCIAL HYSTERECTOMY AND RIGHT SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2014 FOR UNSTAGED ADENOCARCINOMA OF THE ENDOMETRIUM. DURING THE SAME PROCEDURE, THE PATIENT ALSO UNDERWENT A DIAGNOSTIC LAPAROSCOPY, WASHINGS, LYSIS OF ADHESIONS, AND PELVIC SENTINEL LYMPH NODE REMOVAL. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT IN ADDITION TO PATIENT MEDICAL AND LEGAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A LEGAL DOCUMENT PROVIDED CLAIMS THAT THE SURGEONS CUT, NICKED, TORE, BURNED OR OTHERWISE DISRUPTED THE SIGMOID COLON IN ONE OR MORE LOCATIONS. IN ADDITION, THE LEGAL DOCUMENT NOTES, IN AN ATTEMPT TO REPAIR ONE OF THE INJURIES TO THE SIGMOID COLON, THE SURGEONS PLACED SUTURES. PER THE DA VINCI OPERATIVE REPORT, OPERATIVE FINDINGS INCLUDED THE FOLLOWING: THE LAPAROSCOPY REVEALED SOME PERIHEPATIC ADHESIONS. SHE HAD SOME ADHESIONS IN THE PELVIC AREA IN THE SITE OF HER PREVIOUS SURGERY. BIOPSY FROM THIS AREA SHOWED GRANULATION TISSUE WITH NO OBVIOUS M

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A DAVINCI ASSISTED LEFT UPPER LOBECTOMY, THE SURGEON PLACED A LARGE HEM-O-LOK CLIP ON THE PULMONARY ARTERY AND CLIPPED IT. THE CLIP DID NOT RELEASE FROM THE INSTRUMENT, WHEN THE INSTRUMENT WAS PULLED BACK THE CLIP TORE THE ARTERY. AS A RESULT THE CASE CONVERTED TO AN OPEN PROCEDURE.

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 1 HOUR AND 90 MINUTES.

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 CHOLECYSTECTOMY PROCEDURE, THE ELECTROSURGICAL UNIT (ESU) MISFIRED AND THE PATIENT SUSTAINED AN EXTERNAL BURN. SPECIFIC DETAILS REGARDING THE BURN WERE NOT PROVIDED. ON THE SAME DAY THE EVENT OCCURRED, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE EVALUATED THE DA VINCI SURGICAL SYSTEM AND WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. THE FSE TESTED THE SYSTEM USING THE ORIGINAL MONOPOLAR CABLE AND GROUNDING PAD USED DURING THE REPORTED EVENT. NO ISSUES WERE FOUND WITH THE ENERGY PEDAL ON THE SURGEON SIDE CONSOLE (SSC). THE FSE WAS ABLE TO SIMULATE CAUTERY ON THE DA VINCI SURGICAL SYSTEM USING A SPONGE SOAKED IN SALT WATER. THE FSE ALSO VERIFIED THAT WITH THE DA VINCI INSTRUMENT REMOVED OR WITH THE HEAD SENSOR BLOCKED, THE SSC WOULD NOT ACTIVATE THE ESU. THE FSE REVIEWED SITE'S SYSTEM ERROR LOGS. NO ERRORS RELATED TO THE SSC AND PERSONALITY MODULE ENERGY DEVICE (PMED) WHERE THE ESU IS PLUGGED INTO WERE FOUND. THE FSE THEN TESTED THE SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. ON (B)(4) 2014, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS NOT PRESENT DURING T

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2014, THE SURGEON NOTICED A SLIGHT HOLE IN THE PATIENT'S BLADDER. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGERY LASTED ABOUT 1 HOUR AND 40 MINUTES. THE PATIENT WAS READMITTED ON (B)(6) 2014 AND WAS FOUND TO HAVE A PELVIC ABSCESS. ON (B)(4) 2014, 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 AND NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. A FEW DAYS AFTER THE DA VINCI HYSTERECTOMY PROCEDURE WAS COMPLETED, THE PATIENT RETURNED TO THE HOSPITAL AND WAS TREATED WITH ANTIBIOTICS. THE PATIENT WAS FOUND TO HAVE A PELVIC ABSCESS, HIGH FEVER, AND AN ELEVATED WHITE BLOOD CELL (WBC) COUNT. NO ADDITIONAL POST-OPERATIVE COMPLICATIONS WERE REPORTED. ON (B)(4) 2014, ISI CONTACTED THE SITE'S DIRECTOR OF SURGICAL SERVICES. ACCORDING TO THE DIRECTOR OF SURGICAL SERVICES, THE BLADDER INJURY WAS CAUSED BY SURGEON ERROR AND WAS SUCCESSFULLY REPAIRED BY THE SURGEON USING 2-3 STITCHES DURING THE DA VINCI HYSTERECTOMY PROC

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 SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SURGEON WHO PERFORMED THE DA VINCI SURGICAL PROCEDURE. ACCORDING TO THE SURGEON, THE PATIENT UNDERWENT A DA VINCI SLEEVE GASTRECTOMY PROCEDURE ON (B)(6) 2014. ON (B)(6) 2014, THE PATIENT EXPERIENCED SYMPTOMS OF A POST-SURGICAL LEAK. THE PATIENT HAD A SMALL LEAK NEAR THE GASTROESOPHAGEAL (GE) JUNCTION, PRESUMABLY FROM THE STAPLE LINE. THE SURGEON INDICATED THAT INITIALLY IT WAS BELIEVED THAT THE PATIENT HAD AN INFECTED HEMATOMA. PERCUTANEOUS DRAINS WERE PLACED BY RADIOLOGY TO RESOLVE THE ABDOMINAL FLUID COLLECTIONS. AFTER THE PERCUTANEOUS DRAINS WERE REMOVED, THE ISSUE RECURRED. ON (B)(6) 2014 THE PATIENT UNDERWENT LAPAROSCOPIC EXPLORATION AND DRAIN PLACEMENT; HOWEVER, THE LEAK WAS NOT LOCATED. LATER IN THE PATIENT'S COURSE SHE UNDERWENT A PROCEDURE TO HAVE A STENT PLACED TO COVER THE LEAK FROM INSIDE OF THE STOMACH. ACCORDING TO THE SURGEON, AS OF (B)(6) 2014, THE PATIENT WAS IN THE HOSPITAL AND IN STABLE CONDITION. THE SURGEON INDICATED THAT 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 DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE ASSISTING SURGEON ATTEMPTED TO REMOVE A NEEDLE THROUGH A LAPAROSCOPIC ASSIST PORT AND THE NEEDLE WAS LOST. AFTER THE VAGINAL CUFF WAS CLOSED, THE ROBOT WAS UNDOCKED FROM THE PATIENT. THE NEEDLE WAS FOUND IN THE ABDOMINAL WALL AFTER AN X-RAY WAS PERFORMED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. TOWARDS THE END OF THE SURGICAL PROCEDURE WHILE THE SURGEON WAS CLOSING THE VAGINAL CUFF, THE ASSISTING SURGEON ATTEMPTED TO REMOVE A NEEDLE THROUGH A LAPAROSCOPIC ASSIST PORT USING AN UNIDENTIFIED NON-ISI LAPAROSCOPIC INSTRUMENT AND WITHOUT DIRECT VISUALIZATION. THE INITIAL REPORTER STATED THAT THE LAPAROSCOPIC ASSIST PORT WAS ACTUALLY A DA VINCI PORT BUT WAS SOLELY USED AS A LAPAROSCOPIC ASSIST PORT BY THE SURGICAL STAFF. THE INITIAL REPORTER INDICATED THAT THE DA VINCI SURGICAL SYSTEM WAS NEVER DOCKED TO THE LAPAROSCOPIC ASSIST PORT INVOLVED WITH THIS COMPLAINT. AFTER THE ASSISTING SURGEON REMOVED THE LAPAROSCOPIC INSTRUMENT FROM T

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A SINGLE-SITE DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT'S URETER WAS TRANSECTED. REPORTEDLY, NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED PROCEDURE USING THE DA VINCI SURGICAL SYSTEM. A UROLOGIST WAS CONSULTED TO REPAIR THE DEFECT TO THE PATIENT'S URETER. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR, HE WAS PRESENT DURING THE SURGICAL PROCEDURE. THE DAMAGE TO THE PATIENT'S URETER WAS IDENTIFIED IMMEDIATELY AND HE HEARD THE SURGEON COMMENT THAT THE DAMAGE TO THE PATIENT'S URETER OCCURRED BECAUSE THE PATIENT HAD AN UNUSUAL ANATOMY. AFTER COMPLETION OF THE ROBOTICS PROCEDURE THE DECISION WAS MADE TO REPAIR THE DAMAGE TO THE PATIENT'S URETER USING OPEN SURGICAL TECHNIQUES. THE CSR INDICATED THAT HE WAS NOT PRESENT DURING THE OPEN SURGICAL PROCEDURE.

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 THE FIRST HOUR OF THE DA VINCI ADRENALECTOMY PROCEDURE, THE SURGEON NICKED A BRANCH OF A RENAL VEIN. THE SURGEON WAS ABLE TO CONTROL BLEEDING THAT ENSUED BY USING A MARYLAND BIPOLAR FORCEPS INSTRUMENT INSTALLED ON PATIENT SIDE MANIPULATOR (PSM) 2. THE SURGEON THEN MADE THE DECISION TO CONVERT THE DA VINCI ADRENALECTOMY PROCEDURE TO OPEN SURGICAL TECHNIQUES IN ORDER TO SUTURE THE VESSEL. AT AN UNSPECIFIED TIME DURING THE REMAINDER OF THE OPEN SURGICAL PROCEDURE, THE PATIENT'S VENA CAVA WAS INJURED. THE PATIENT WAS THEN TRANSPORTED TO ANOTHER FACILITY AND SUBSEQUENTLY PASSED AWAY. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGEON INDICATED THAT THE CAUSE OF THE PATIENT'S DEATH WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT'S RENAL ARTERY WAS NICKED BY THE SURGEON. HOWEVER, SHE STATED THAT THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUM

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 PC WAS NON-FUNCTIONAL. NO PATIENT IMPACT WAS REPORTED. A SURGERY DELAY HAS BEEN REPORTED OF 40 MINUTES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MY GYNECOLOGIST RECOMMENDED THE DA VINCI TO ME. SHE SAID IT WAS THE WAY TO GO. ON (B)(6) 2014, I HAD MY PLANNED SURGERY BUT I NEVER RECOVERED. I WAS NAUSEATED THE FIRST WEEK ((B)(6) BACK TO WORK, SO I HAD CALLED AND ASKED FOR SOMETHING TO CONTROL THE NAUSEA. I HAD NO BLADDER CONTROL BEGINNING (B)(6). I HAD A WETTING ACCIDENT AT WORK. I THOUGHT I HAD A BAD UTI. I KEPT CALLING MY DR'S OFFICE AND FINALLY GOT IN TO SEE HER AND SHE REFERRED ME THE SAME DAY TO A UROLOGIST. I HAD TO WEAR ADULT DIAPERS SINCE (B)(6). ON (B)(6) 2014 MET WITH A UROLOGIST ON A FRIDAY, AND HE TOLD ME THAT HE NEEDED TO SEE ME IN THE OPERATING ROOM ON THE FOLLOWING MONDAY TO PLACE A STENT IN. THE RIGHT URETER HAD STOPPED WORKING. ON (B)(6) 2014 THE STENT WAS REMOVED. SIX DAYS LATER, (B)(6) 2014, I FELL ILL AT WORK. MY STOMACH HAD SWELLED AND I COULD HEAR WATER GUSHING THROUGH MY STOMACH. I CALLED MY DOCTOR. HE SAID GO GET MRI AT THE HOSPITAL AND BRING HIM THE DVD. I WAS IN HIS OFFICE AT 1:30 AND HE SAID I NEED TO SEE YOU IN THE OPERATING ROOM AT 2:00. I HAD FLUID BACKING UP IN THE RIGHT KIDNEY. ON (B)(6), DR (B)(6) REPLACED THE STENT. ON (B)(6) 2014, I WENT TO (B)(6) FOR A SECOND OPINION. THE DOCTOR THERE SAID "Y

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 AS A RESULT OF UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE PATIENT CLAIMED THAT HER RIGHT URETER WAS BURNED, NICKED, OR CUT. IN RELATION TO THE REPORTED EVENT, ON 01/07/2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5058544 WITH THE FOLLOWING EVENT DESCRIPTION: MY GYNECOLOGIST RECOMMENDED THE DA VINCI TO ME. SHE SAID IT WAS THE WAY TO GO. ON (B)(6) 2014, I HAD MY PLANNED SURGERY BUT NEVER RECOVERED. I WAS NAUSEATED THE FIRST WEEK (B)(6) BACK TO WORK, SO I HAD CALLED AND ASKED FOR SOMETHING TO CONTROL THE NAUSEA. I HAD NO BLADDER CONTROL BEGINNING (B)(6) . I HAD A WETTING ACCIDENT AT WORK. I THOUGHT I HAD A BAD UTI. I KEPT CALLING MY DR'S OFFICE AND FINALLY GOT IN TO SEE HER AND SHE REFERRED ME THE SAME DAY TO A UROLOGIST. I HAD TO WEAR ADULT DIAPERS SINCE (B)(6). ON (B)(6) 2014 MET WITH A UROLOGIST ON A FRIDAY, AND HE TOLD ME THAT HE NEEDED TO SEE ME IN THE OPERATING ROOM ON THE FOLLOWING MONDAY TO PLACE A STENT IN. THE RIGHT URETER HAD STOPPED WORKING. ON (B)(6) 2014 THE STENT WAS REMOVED. SIX DAYS LATER, (B)(6), I FELL ILL AT WORK. MY STOMACH HAD SWELLED AND I COULD HEAR WATER GUSHING THROUGH MY STOMACH. I CALLED MY DOCTOR

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 LEFT SALPINGO-OOPHORECTOMY PROCEDURE, THE PATIENT SUSTAINED A BOWEL INJURY THAT THE SURGEON FELT WAS LIKELY DUE TO A THERMAL ISSUE. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT THE PATIENT WAS STILL IN THE HOSPITAL, HAD ENDED UP DEVELOPING AN ABSCESS, AND RECEIVED A COLOSTOMY. THE PATIENT'S CONDITION WAS REPORTEDLY IMPROVING. ON (B)(64 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON INVOLVED WITH THIS COMPLAINT AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGEON DESCRIBED THE THERMAL BOWEL INJURY AS BEING 1 CM IN SIZE AND LOCATED IN THE SIGMOID COLON. ACCORDING TO THE SURGEON, NO INAPPROPRIATE CONTACT WITH ENERGIZED INSTRUMENTS WHILE ACTIVATED WAS OBSERVED DURING THE DA VINCI SURGICAL PROCEDURE. IN ADDITION, THE BOWEL INJURY WAS NOT SEEN OR NOTICED INTRA-OPERATIVELY. THE SURGEON DENIED THAT ANY EVIDENCE OF ARCING OF ELECTRICAL ENERGY FROM AN INSTRUMENT WAS OBSERVED DURING THE SURGICAL PROCEDURE. TEN DAYS POST-OPERATIVELY, THE PATIENT WAS READMITTED FOR COMPLAINTS OF PAIN AND A CT-SCAN WAS PERFORMED. THE PATIENT'S BOWEL INJURY WAS SURGICALLY REPAIRED. DETAILS OF THE SURGICAL REPAIR WERE NOT 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 DURING A DA VINCI RIGHT HEMICOLECTOMY PROCEDURE, AFTER THE PHYSICIAN'S ASSISTANT AT THE PATIENT SIDE CART INSTALLED AN ENDOWRIST INSTRUMENT, THE SURGEON WAS UNAWARE THAT HE HAD CONTROL OF THE INSTALLED INSTRUMENT AS HE WAS UNABLE TO VIEW THE INSTRUMENT THROUGH THE HIGH RESOLUTION STEREO VIEWER ON THE SURGEON SIDE CART BECAUSE THE ENDOSCOPE WAS NOT COMPLETELY INSERTED INTO THE PATIENT. AFTER THE SURGEON LOCATED THE INSTRUMENT, HE NOTED THAT HE HAD CREATED A SMALL INCISION. THE SURGEON REPAIRED THE DEFECT WITH SUTURES. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR, SHE WAS PRESENT DURING SET-UP OF THE SYSTEM; HOWEVER, SHE DID NOT WITNESS THE INJURY TO THE PATIENT AS SHE LEFT THE OR. THE CSR INDICATED THAT UPON HER RETURN TO THE OPERATING ROOM, SHE OBSERVED THAT THE SURGEON WAS TRYING TO LOCATE THE TIPS OF THE INSTALLED INSTRUMENTS AND AFTER THE SURGEON LOCATED THE TIPS OF THE INSTRUMENTS SHE OVERHEARD THE SURGEON STATE THAT HE HAD CREATED A HOLE IN THE PATIENT'S DUODENUM. THE SURGEON USED THE DA VINCI SURGICAL SYSTEM TO REPAIR THE DEFECT USING SUTURES. THE CSR

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 4 HOURS POST A DA VINCI SINGLE SITE HYSTERECTOMY PROCEDURE, THE PATIENT REPORTED THAT SHE WAS NOT FEELING WELL AND PASSED OUT. A CT SCAN PERFORMED ON THE PATIENT SHOWED BLOOD IN HER ABDOMEN. THE PATIENT WAS RETURNED TO THE OPERATING ROOM AND IT WAS DISCOVERED THAT THE PATIENT WAS BLEEDING FROM HER LEFT UTERINE ARTERY. REPORTEDLY, THE PATIENT'S BLEEDING WAS CONTROLLED AND THE PATIENT IS RECOVERING FINE. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR HE WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE AND THAT DURING THE SURGICAL PROCEDURE, HE DID NOT OBSERVE ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. THE CSR INDICATED THAT TOWARDS THE END OF THE SURGICAL PROCEDURE, WHILE THE SURGEON WAS CLOSING THE PATIENT'S VAGINAL CUFF, INSUFFLATION WAS LOST. AT THAT TIME THE SURGEON MADE THE DECISION TO COMPLETE THE CLOSURE OF THE PATIENT'S VAGINAL CUFF VAGINALLY. THE LOSS OF INSUFFLATION WAS RELATED TO A THIRD PARTY DEVICE AND NOT TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES. AT THE END OF THE PROCEDURE, THE SURGICAL A

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI MYOMECTOMY PROCEDURE PERFORMED ON (B)(6) 2014, THE PATIENT WAS RE-ADMITTED INTO THE HOSPITAL DUE TO DEEP VEIN THROMBOSIS (DVT) AND A PULMONARY EMBOLISM. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR SHE WAS NOT PRESENT DURING THE PATIENT'S ROBOTIC PROCEDURE; HOWEVER, ANOTHER ISI CSR WAS PRESENT AND ACCORDING TO THAT CSR, NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. THE REPORTING CSR INDICATED THAT SHE SPOKE TO THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. ACCORDING TO THE SURGEON, THE PATIENT'S DA VINCI MYOMECTOMY PROCEDURE WAS COMPLETED AND TOOK 3 HOURS. THE SURGEON STRUGGLED TO LOCATE THE PATIENT'S MYOMA DUE TO INACCURATE MRI RESULTS, CAUSING THE SURGEON TO CREATE THE HYSTEROTOMY IN AN AREA THAT WAS NOT IDEAL FOR ACCESSING THE PATIENT'S MYOMA, WHICH RESULTED IN A DELAY DURING THE SURGICAL PROCEDURE. THERE WAS A PROCTOR IN THE OR DURING THE SURGICAL PROCEDURE TO ASSIST WITH THE INTERPRETATION OF THE MRI. THE CSR WAS TOLD BY THE SURGEON THAT THE DA VINCI SURGICAL S

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED AN UF/IMPORTER REPORT (B)(4), WITH THE FOLLOWING EVENT DESCRIPTION: THE SURGEON ASKED FOR A UROLOGY CONSULT DUE TO A POSSIBLE THERMAL INJURY TO A URETER. A SECOND PHYSICIAN CAME IN AND CONFIRMED THERE WAS A URETERAL INJURY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE 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 SURGICAL PROCEDURE, THE PATIENT SUSTAINED A COMMON BILE DUCT INJURY. NO OTHER INFORMATION REGARDING THE REPORTED EVENT WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL, INC. (ISI) RECEIVED (B)(4), WITH THE FOLLOWING INFORMATION: DURING ROBOTIC LYMPH NODE DISSECTION, THE PHYSICIAN CUT THE LEFT URETER. THE UROLOGIST ON CALL FIXED THE URETER FOLLOWING ORIGINAL PROCEDURE ROBOTICALLY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. ISI CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED THE FOLLOWING INFORMATION: THE SURGEON WAS DISSECTING THE GOOD PERITONEUM AND SKELETONIZING THE NODAL BUNDLE WHEN THE INJURY OCCURRED TO A PATIENT. IT IS UNKNOWN HOW LONG THE PROCEDURE WAS IN PROGRESS WHEN THE INJURY OCCURRED TO THE PATIENT. THE INITIAL REPORTER WAS UNABLE TO PROVIDE THE SURGEON'S BELIEF AS TO WHAT CAUSED OR CONTRIBUTED TO THE URETERAL INJURY. THE UROLOGIST USED 4 LATERAL STITCHES TO REPAIR THE INJURY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. THE PATIENT HAS NOT RETURNED BACK TO THE HOSPITAL DUE TO THE REPORTED INJURY. THE INITIAL REPORTER WAS UNABLE TO PROVIDE ISI ANY FURTHER ADDITIONAL INFORMATION REGARDING THIS CASE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT EXPERIENCED VAGINAL CUFF DEHISCENCE REQUIRING THE PATIENT TO UNDERGO AN ADDITIONAL SURGICAL PROCEDURE ON (B)(6) 2014 TO REPAIR HER VAGINAL CUFF. REPORTEDLY, REPAIR OF THE PATIENT'S VAGINAL CUFF WAS PERFORMED AT ANOTHER HOSPITAL. THE DATE OF THE DA VINCI HYSTERECTOMY PROCEDURE WAS NOT PROVIDED BY THE REPORTING HOSPITAL. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE NURSE AT THE HOSPITAL WHO REPORTED THIS INCIDENT TO ISI'S CLINICAL SALES REPRESENTATIVE (CSR). ACCORDING TO THE NURSE, THE PATIENT PRESENTED WITH SYMPTOMS OF VAGINAL CUFF DEHISCENCE AT THE HOSPITAL ON (B)(6) 2014. THE PATIENT'S VAGINAL CUFF WAS REPAIRED VAGINALLY. THE AFFECTED AREA WAS SUTURED. THE NURSE INDICATED THAT THE SURGEON WHO REPAIRED THE PATIENT'S VAGINAL CUFF DID NOT INDICATED WHAT CAUSED OR CONTRIBUTED TO THE ISSUE. THE NURSE DID NOT KNOW WHAT DATE THE PATIENT UNDERWENT THE DA VINCI SURGICAL PROCEDURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. 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: IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT'S BOWEL WAS PUNCTURED WHILE ADVANCING THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INTO THE PATIENT. REPORTEDLY, THE AFFECTED AREA WAS REPAIRED. ON (B)(4) 2014 INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. ACCORDING TO THE SURGEON THE PATIENT'S BOWEL WAS NOT PENETRATED; HOWEVER, THE SEROSA WAS DAMAGED. THE DEFECT WAS REPAIRED INTRA-OPERATIVELY WITH THE DA VINCI SURGICAL SYSTEM. THE AFFECTED AREA WAS SUTURED AND NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. THE SURGEON INDICATED THAT THE BEDSIDE ASSISTANT WAS PERFORMING ANOTHER TASK AND WAS NOT PAYING ATTENTION WHILE THE MCS INSTRUMENT WAS BEING ADVANCED INTO THE PATIENT, THUS CAUSING DAMAGE TO THE PATIENT'S SEROSA. ACCORDING TO THE SURGEON, THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, MCS INSTRUMENT OR ACCESSORIES THAT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT AND IT IS HIS BELIEF THAT THE DEFECT TO THE PATIENT'S SEROSA WAS USE ERROR RELATED. THE PLANNED SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT RECOVERED WELL. THE SURGEON ALSO INDICATED THAT ONE WEEK POST THE SURGICAL PROCEDU

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 A PATIENT HAD DIED AFTER UNDERGOING A DA VINCI LUNG LOBECTOMY PROCEDURE ON (B)(6) 2014. AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WAS PRESENT DURING MOST OF THE DA VINCI PROCEDURE AND CLAIMS THAT THERE WAS NO REPORTED SYSTEM MALFUNCTION THAT OCCURRED DURING THE PROCEDURE. THE CSR WAS INFORMED ON (B)(4) 2014 BY THE SURGEON THAT THE PATIENT HAD DIED. THE SURGEON TOLD THE CSR THAT THE PATIENT'S DEATH WAS NOT RELATED TO THE DA VINCI SYSTEM. PER THE CSR, THIS PATIENT HAD BEEN ALREADY TREATED WITH RADIOTHERAPY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED TO ISI ABOUT THIS CASE.

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 MITRAL VALVE REPAIR WITH MAZE PROCEDURE, WHEN THE SURGEON WENT TO CLAMP THE PATIENT, HE OBSERVED THAT THE PATIENT HAD AN AORTIC DISSECTION. AS A RESULT THE SURGEON CONVERTED THE PROCEDURE TO AN OPEN STERNOTOMY. APPROXIMATELY 2 HOURS INTO THE OPEN PROCEDURE IT WAS DISCOVERED THAT THE PATIENT'S LEFT VENTRICLE WAS NOT FUNCTIONING AND AN ATTEMPT WAS MADE TO RESUSCITATE THE PATIENT'S LEFT VENTRICLE. REPORTEDLY, THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). APPROXIMATELY 2 DAYS LATER A CT SCAN PERFORMED ON THE PATIENT SHOWED THAT THE PATIENT HAD NO BRAIN ACTIVITY AND LATER THAT SAME DAY THE PATIENT EXPIRED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR, SHE WAS PRESENT DURING THE SURGICAL PROCEDURE. REPORTEDLY, THE PATIENT WAS NEVER TAKEN OFF BYPASS WHEN THE INCIDENT OCCURRED. ON (B)(4) 2014, THE CSR SPOKE TO THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. ACCORDING TO THE SURGEON, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES, BUT WAS DUE TO T

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI BENIGN HYSTERECTOMY PROCEDURE, THE PATIENT'S BLADDER WAS PERFORATED. REPORTEDLY, THE DAMAGE TO THE PATIENT'S BLADDER WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM. THE PATIENT'S BLADDER WAS REPAIRED USING THE DA VINCI SURGICAL SYSTEM. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT. THE INITIAL REPORTER WAS PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE INITIAL REPORTER THE SURGEON HAD DIFFICULTY DELINEATING THE PATIENT'S TISSUE PLANES AND WHILE ATTEMPTING TO PERFORM THE COLPOTOMY PORTION OF THE HYSTERECTOMY PROCEDURE USING A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, THE SURGEON INADVERTENTLY PERFORATED THE PATIENT'S BLADDER WHILE CAUTERY ENERGY WAS ACTIVATED. THE DAMAGE TO THE PATIENT'S BLADDER WAS IMMEDIATELY RECOGNIZED BY THE SURGEON, AS THE SURGEON OBSERVED THAT THE INSTALLED CATHETER WAS VISIBLE. THE SURGEON REPAIRED THE DEFECT TO THE PATIENT'S BLADDER LAPAROSCOPICALLY USING THE DA VINCI SURGICAL SYSTEM. THE AFFECTED AREA WAS SUTURED. AFTER THE 1ST REPAIR WAS COMPLETED, THE SURGEON OBSERVED LEAKAGE FROM THE REPAIRED AREA. THE SURGEON PERFORMED A 2ND REPAIR USING THE DA VINCI SURGI