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 RIGHT HEMICOLECTOMY PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 7. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE PATIENT BEGAN TO REFUSE HIS MEDICATIONS AND HAD PULLED OUT HIS NG TUBE PRIOR TO PASSING AWAY. SHE ALSO INDICATED THAT POSSIBLY THE PATIENT ASPIRATED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE CSR, HE WAS PRESENT DURING PARTS OF THE DA VINCI SURGICAL PROCEDURE. DURING THE TIMES THAT HE WAS PRESENT, THE CSR INDICATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED. THE CSR STATED THAT AN INITIAL AUTOPSY WAS PERFORMED AND THE PATIENT WAS FOUND TO HAVE DEVELOPED ILEUS. IN ADDITION, THE PATIENT'S STAPLE LINE HAD RUPTURED. ON (B)(4) 2014, ISI CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER REVIEWED THE OPERATIVE REPORT AND DID NOT FIND ANY REPORTS THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED. THE RISK MANAGER STATED THAT BASED ON THE OPERATIVE REPORT AND THE SITE'S PREL

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 HAS BEEN DETECTED. A DISPLAY ERROR WAS NOTICED, THE IMAGERY AND THE POINTER WERE NOT VISIBLE. A SURGERY DELAY HAS BEEN REPORTED BETWEEN 1:30 HOUR AND 2 HOURS.

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 PLANIFICATION ISSUE. A SURGERY DELAY HAS BEEN REPORTED BETWEEN 1:30 HOUR AND 2 HOURS.

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 HAS BEEN DETECTED. IT WAS IMPOSSIBLE TO PERFORM THE REGISTRATION STEP. A SURGERY DELAY HAS BEEN REPORTED BETWEEN 1:30 HOUR AND 2 HOURS.

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 SINGLE-SITE CHOLECYSTECTOMY, THE SURGEON INADVERTENTLY CUT THE PATIENT'S COMMON BILE DUCT WHILE LIGATING AND CUTTING THE PATIENT'S CYSTIC DUCT WITH THE MONOPOLAR HOOK INSTRUMENT. THERE WAS NO ALLEGATION THAT THE MONOPOLAR HOOK INSTRUMENT MALFUNCTIONED DURING THE EVENT. THE SURGEON THEN MADE THE DECISION TO CONVERT THE SURGICAL PROCEDURE TO OPEN SURGERY. THE SURGEON WAS ABLE TO REPAIR THE COMMON BILE DUCT AND THE CHOLECYSTECTOMY PROCEDURE WAS COMPLETED VIA OPEN SURGERY. THE PATIENT REMAINED HOSPITALIZED FOR 3-4 DAYS AND WAS IN STABLE CONDITION UPON DISCHARGE. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, HE WAS INFORMED THAT THE PATIENT WAS FOUND DECEASED IN HER HOME. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER INDICATED THAT THE CASE IS UNDER INVESTIGATION. THE RISK MANAGER WAS UNABLE AND UNWILLING TO PROVIDE ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT.

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. IT HAS BEEN REPORTED THAT THE SURGERY HAS BEEN CANCELLED

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 OR DEVICE MALFUNCTIONS. THESE ALLEGATIONS WERE FIRST RECEIVED BY INTUITIVE SURGICAL, INC. DURING THE TIME PERIOD OF (B)(4) 2014. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (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: IT WAS REPORTED THAT DURING A DA VINCI NEPHRECTOMY PROCEDURE, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES. HOWEVER, THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT THE CONVERSION TO OPEN SURGERY WAS UNRELATED TO ANY ISSUES WITH THE DA VINCI SURGICAL SYSTEM. SHE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. HOWEVER, THE INITIAL REPORTER WAS INFORMED THAT THE ROBOTIC PART OF THE PROCEDURE HAD ALREADY BEEN COMPLETED BY THE TIME THE SURGEON DECIDED TO CONVERT TO OPEN SURGERY. SHE INDICATED THAT THE SURGICAL PROCEDURE WAS COMPLETED ALTHOUGH THE PATIENT WAS NOT DOING WELL POST-OPERATIVELY. ON (B)(6) 2014, THE INITIAL REPORTER WAS NOTIFIED BY THE SITE THAT THE PATIENT HAD PASSED AWAY. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT. THE SURGEON WAS AWARE THAT THE DA VINCI NEPHRECTOMY WAS GOING TO BE DIFFICULT EVEN BEFORE THE PROCEDURE BEGAN. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGERY DUE TO THE SIZE AND LOCATION OF THE PATIENT'S TUMOR

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE SCHEDULED FOR ROBOTIC ASSISTED HYSTERECTOMY. THE SURGEON STARTED THE PROCEDURE; THE UTERUS WAS LIFTED UP AND TO THE PATIENT'S RIGHT SIDE TO EXPOSE THE LEFT UTEROOVARIAN PEDICLE. THIS WAS ATTEMPTED TO BE CAUTERIZED WITH THE PK IN 3 CONTIGUOUS AREAS AND CUT WITH SCISSORS. HOWEVER, THE MONOPOLAR AND BIPOLAR SCISSORS WERE FOUND TO BE NON-FUNCTIONING. AT THIS TIME, DECISION WAS MADE TO CONVERT TO ABDOMINAL HYSTERECTOMY. THE SURGEON DECIDED TO ABORT THE ROBOTIC PORTION OF 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 DURING A DA VINCI SIGMOID COLECTOMY PROCEDURE, A SMALL VEIN WAS PUNCTURED AND THE CASE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES. THE CAUSE OF THE VESSEL PUNCTURE WAS UNKNOWN. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE INITIAL REPORTER, SHE WAS PRESENT DURING THE SURGICAL PROCEDURE AND THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, AND/OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE VESSEL INJURY OCCURRED APPROXIMATELY 1.5 HOURS INTO THE SURGICAL PROCEDURE. A VASCULAR SURGEON WAS CONTACTED AFTER THE INJURY OCCURRED AND THE CASE WAS CONVERTED TO OPEN SURGERY. THE VASCULAR SURGEON WAS ABLE TO REPAIR THE PUNCTURED VEIN AND THE SIGMOID COLECTOMY PROCEDURE WAS COMPLETED VIA OPEN SURGERY. THE INITIAL REPORTER SPOKE TO THE SURGEON AFTER COMPLETION OF THE SURGERY. ACCORDING TO THE INITIAL REPORTER, THE SURGEON DID NOT KNOW WHAT CAUSED THE VESSEL INJURY. A WEEK AFTER THE EVENT OCCURRED, THE SURGEON REPORTEDLY INFORMED THE INITIAL REPORTER THAT THE PATIENT WAS DOING FINE.

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 SACROCOLPOPEXY PROCEDURE, THE SURGEON FELT AS THOUGH SHE DID NOT HAVE FULL RANGE OF MOTION WHEN THE INSTRUMENTS WERE FIRST INSTALLED. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGEON INDICATED THAT THE RANGE OF MOTION RETURNED. HOWEVER, WHILE MOVING THE INSTRUMENTS, THE SURGEON FOUND AN ARTERY THAT WAS ALLEGEDLY NICKED BY A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. THE DA VINCI SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY. ON (B)(6) 2014, THE INITIAL REPORTER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE REGARDING THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGERY DUE TO ENCOUNTERING SYSTEM ERRORS. THE TSE REVIEWED THE SITE'S SYSTEM LOGS AND NOTED THAT A SINGLE ERROR CODE 100 HAD OCCURRED DURING THE SURGICAL PROCEDURE. AN ERROR CODE 100 IS AN INFORMATIONAL FAULT THAT SIGNIFIES THAT AN UNEXPECTED SETUP JOINT (SUJ) MOVEMENT WAS DETECTED. ON (B)(4) 2014, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE EVALUATED THE DA VINCI SURGICAL SYSTEM AND WAS UNABLE TO REPLICATE THE REPORTED I

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.