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

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

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

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

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

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

da Vinci Surgical System — 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 BOWEL SURGERY PROCEDURE ON (B)(6) 2011. ACCORDING TO THE LEGAL DOCUMENT, THE PATIENT SUFFERED A SEVERE INFECTION WHICH RESULTED IN A SECOND HOSPITALIZATION, A HIGH TEMPERATURE, WHICH LEAD TO A STROKE AND HER PASSING AWAY. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT AND DISCHARGE SUMMARY. BASED ON THE OPERATIVE REPORT, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THERE WAS ALSO NO INDICATION THAT AN INTRA-OPERATIVE COMPLICATION OCCURRED. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION AFTER COMPLETION OF THE SURGICAL PROCEDURE. THE PATIENT WAS DISCHARGED HOME ON POST-OPERATIVE DAY 1 ((B)(6) 2011). ACCORDING TO THE DISCHARGE SUMMARY, THE OPERATIVE AND POST OPERATIVE COURSE WAS UNCOMPLICATED. ON (B)(4) 2014, ISI CONTACTED THE RISK MANAGEMENT DEPARTMENT FROM THE SITE. THE RISK MANAGER REVIEWED THE OPERATIVE REPORT AND CONFIRMED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED. THE RISK MANAGER ALSO DID NOT FIND ANY ADDITIONAL

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI COLON RESECTION PROCEDURE ON (B)(6) 2011 AND SUBSEQUENTLY EXPIRED ON AN UNSPECIFIED DATE. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT AND ADDITIONAL HOSPITAL REPORTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION ALTHOUGH THE OPERATION HAD TO BE CONVERTED TO AN OPEN PROCEDURE DUE TO THE SIZE OF THE TUMOR. THE PATIENT WAS ADMITTED TO THE HOSPITAL FROM (B)(6) 2011. NO FURTHER MEDICAL RECORDS WERE PROVIDED. A LETTER FROM AN ATTORNEY INDICATES THAT THE PATIENT SUSTAINED A BOWEL PERFORATION, UNDERWENT ADDITIONAL SURGERIES, AND THEN PASSED AWAY. THE PATIENT'S DATE AND CAUSE OF DEATH WERE NOT PROVIDED. ISI HAS MADE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE ATTORNEY AND THE SITE'S RISK MANAGEMENT GROUP; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE IF ADDITIONAL INFORMATION IS RECEIVED.

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 SURGICAL PROCEDURE ON (B)(6), 2008 AT AN UNSPECIFIED HOSPITAL AND SUBSEQUENTLY EXPIRED ON AN (B)(6) 2008. NO OTHER INFORMATION REGARDING THE REPORTED ALLEGATION WAS PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY BILATERAL SALPINGO-OOPHORECTOMY FOR ABNORMAL UTERINE BLEEDING, MENORRHAGIA, UTERINE HYPERTROPHY, UTERINE FIBROIDS, AND COMPLEX ENDOMETRIAL HYPERPLASIA WITH ATYPICAL ON (B)(6) 2011. ISI WAS PROVIDED WITH THE PATIENT OPERATIVE (OP) REPORT PERTAINING TO HER DA VINCI HYSTERECTOMY BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE, MEDICAL DOCUMENTATION PERTAINING HER PRE-SURGICAL CONDITION, AND CARDIAC CLEARANCE. ISI WAS ALSO PROVIDED MEDICAL DOCUMENTATION PERTAINING TO HER HOSPITALIZATION FROM (B)(6) 2011, THE DATE THE PATIENT DIED AND HER CERTIFICATE OF DEATH. THE PATIENT'S RECORDS HAVE BEEN EXTENSIVELY REVIEWED. ACCORDING TO THE INFORMATION PROVIDED IN THE PATIENT'S OP REPORT FOR HER DA VINCI SURGICAL PROCEDURE ON (B)(6) 2011, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES; HOWEVER, IT WAS INDICATED THAT THE SURGERY WAS COMPROMISED BY THE PATIENT'S HABITUS AND HER EXTREME OBESITY, WHICH REQUIRED ADDITIONAL OPERATING TIME IN PRE-HYSTERECTOMY AND HYSTERECTOMY PORTIONS OF THE PROCEDURE. ON (B)(6) 2011,

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 A DA VINCI SI BILATERAL SALPINGO-OOPHORECTOMY (BSO) WAS COMPLETED, THE PATIENT RETURNED TO THE HOSPITAL THE NEXT DAY OR TWO DAYS POST PROCEDURE COMPLAINING OF PAIN. A GENERAL SURGEON SAW THE PATIENT AND MADE THE DECISION TO OPEN THE PATIENT FOR EXPLORATORY SURGERY WHICH RESULTED IN A DIAGNOSIS OF SEPSIS. IT IS UNKNOWN HOW THE PATIENT WAS TREATED. THE PATIENT EXPIRED ON (B)(6) 2011. SINCE RECEIVING THIS INITIAL REPORT, THE SITE HAS BEEN CONTACTED TO REQUEST ADDITIONAL INFORMATION WITHOUT SUCCESS.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT 56 HOURS AFTER A DA VINCI SI TORS (TRANSORAL ROBOTIC SURGERY) PROCEDURE WAS SUCCESSFULLY PERFORMED, THE PATIENT EXPERIENCED HEAVY BLEEDING AND CARDIOPULMONARY ARREST ENSUED. CPR WAS PERFORMED IN EXCESS OF 20 MINUTES BEFORE THE PATIENT'S PULSE WAS RESTORED AND AS A RESULT, IRREVERSIBLE ANOXIC BRAIN INJURY OCCURRED. ON (B)(6) 2011, THE PATIENT EXPIRED. AT THE TIME OF THE REPORT, THE CAUSE OF THE PATIENT BLEEDING WAS UNDETERMINED. IT WAS ALSO REPORTED THAT DURING THE SURGICAL PROCEDURE, THERE WERE NO SYSTEM FAILURES, NO INJURY TO THE PATIENT, AND NO COMPLICATIONS EXPERIENCED.

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 APPROXIMATELY 45 MINUTES INTO A DA VINCI S OVARIAN CYSTECTOMY PROCEDURE, THE SURGEON ENCOUNTERED EXCESSIVE ADHESIONS WITHIN THE PATIENT'S ANATOMY WHICH MADE IT DIFFICULT TO PERFORM THE PROCEDURE LAPAROSCOPICALLY. AT THIS TIME, THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN TECHNIQUES TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO ISSUES NOTED. APPROXIMATELY TWO TO THREE WEEKS POST PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL AND WAS DIAGNOSED WITH ILEUS. IT IS UNKNOWN HOW THE PATIENT WAS TREATED; HOWEVER, THE PATIENT EXPIRED AFTER BEING DIAGNOSED. THE SITE'S RISK MANAGEMENT DEPARTMENT HAS BEEN CONTACTED SEVERAL TIMES TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, OUR ATTEMPTS HAVE BEEN UNSUCCESSFUL. THE DELAY IN REPORTING IS DUE TO AN ISI EMPLOYEE'S MISUNDERSTANDING OF COMPLAINT REPORTING CRITERIA. THE SITE ADVISED THAT THERE WAS NOT CORRELATION BETWEEN OUR SYSTEM AND THE EVENT AND OUR ISI REPRESENTATIVE UNDERSTOOD THE SITE'S FEEDBACK AS NOT REQUIRING THE INITIATION OF A COMPLAINT RECORD. SINCE THIS MISUNDERSTANDING WAS DISCOVERED, RETRAINING HAS BEEN PERFORMED WITH THE ISI REPRESENTATIVE TO MITIGATE FUTURE OCCURRENCES.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SURGICAL PROCEDURE ON (B)(6) 2011 FOR LOWER ANTERIOR RESECTION FOR OBSTRUCTING RECTOSIGMOID CANCER WHO SUBSEQUENTLY PASSED AWAY ON (B)(6) 2011. ISI WAS NOT PROVIDED WITH THE DA VINCI SURGICAL OPERATIVE REPORT. ADDITIONAL INFORMATION WAS PROVIDED BUT THEY ARE ALL RELATED TO SUBSEQUENT HOSPITALIZATIONS AND NON-ROBOTIC PROCEDURE. ULTIMATELY, THE PATIENT WAS FOUND TO HAVE EXPIRED AT HOME BY HIS SPOUSE ON (B)(6) 2011 AND AN AUTOPSY REPORT WAS INCLUDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE HOSPITAL AUTOPSY'S CLINICAL SUMMARY PROVIDED THE FOLLOWING INFORMATION: THE PATIENT HAD BEEN IN RELATIVELY GOOD HEALTH UNTIL (B)(6) 2011 AT WHICH TIME HE PRESENTED WITH MULTIPLE SYMPTOMS THAT INCLUDED GASTROINTESTINAL BLEEDING, ANEMIA, HYPONATREMIA, HYPERGLYCEMIA, AND FEBRILE ILLNESS. DURING HIS WORKUP, HE WAS ULTIMATELY FOUND TO HAVE NEARLY OBSTRUCTING RECTOSIGMOID MASS, AND UNDERWENT ROBOTIC LOW ANTERIOR RESECTION ON (B)(6) 2011, WITH SPLENIC

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 ON (B)(6), 2011 A PATIENT PASSED AWAY 18 MONTHS AFTER A DA VINCI S PROCEDURE TO REMOVE THE LOWER LOBE OF THEIR LEFT LUNG DUE TO BRONCHIOLOALVEOLAR CARCINOMA. ACCORDING TO THE PATIENT'S HUSBAND, DURING THE PROCEDURE, THE PATIENT'S STOMACH AND DIAPHRAGM WERE PUNCTURED RESULTING IN SEPSIS. THE PATIENT UNDERWENT A 5 MONTH HOSPITAL STAY AND EIGHTEEN MONTHS AS A NEAR INVALID. TO DATE, (B)(6) HAS NOT PROVIDED THE PATIENT'S HUSBAND WITH INFORMATION REGARDING THIS EVENT. INTUITIVE HAS CONTACTED THE SITES RISK MANAGEMENT DEPARTMENT, WHO ADVISED THAT THEY WOULD INVESTIGATE THIS EVENT AND RESPOND BACK TO INTUITIVE WITHIN THE UPCOMING WEEKS.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON APRIL 4, 2012 INTUITIVE SURGICAL WAS CONTACTED BY THE PATIENT'S GRAND-DAUGHTER THAT THE PATIENT UNDERWENT A KIDNEY BIOPSY PROCEDURE USING THE DA VINCI S SURGICAL SYSTEM ON (B)(6) 2011. REPORTEDLY, DURING THE BIOPSY PROCEDURE, THE PATIENT'S RENAL ARTERY WAS DAMAGED. THE PLANNED PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES TO REPAIR THE AFFECTED VESSEL AND THE PATIENT REQUIRED A PARTIAL NEPHRECTOMY AS A RESULT OF THE DAMAGE. THE PATIENT LOST 13 PINTS OF BLOOD. ON (B)(6) 2012, THE PATIENT EXPIRED DUE TO PNEUMONIA, MULTIPLE ORGAN FAILURE AND RENAL FAILURE.

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 A DA VINCI S MITRAL VALVE REPAIR PROCEDURE, THE PATIENTS BLOOD PRESSURE HAD DROPPED, THE SURGEON PERFORMED A MINI THORACOTOMY TO IDENTIFY THE SOURSE OF THE BLOOD PRESSURE LOSS. A LEAK IN THE MITRAL VALVE WAS FOUND AND A STERNOTOMY WAS PERFORMED TO REPAIR OF THE VALVE; HOWEVER, THE PATIENT EXPIRED BEFORE THE VALVE COULD BE REPAIRED. THE SITE HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION RELATED TO THIS EVENT; HOWEVER, NO NEW INFORMATION HAS BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

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 EIGHT DAYS AFTER A DA VINCI SI TONGUE BASE RESECTION (TORS) PROCEDURE WAS SUCCESSFULLY PERFORMED, THE PATIENT EXPIRED DUE TO UNCONTROLLABLE POST OPERATIVE BLEEDING.

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 POST A SUCCESSFUL DA VINCI SI HYSTERECTOMY PROCEDURE THE PATIENT SUFFERED A PERIOPERATIVE LEFT HEMISPHERE CEREBROVASCULAR ACCIDENT (CVA) SECONDARY TO COMPLETE OCCLUSION OF LEFT CAROTID ARTERY (EMBOLIC). POSTOPERATIVELY NOTED TO BE COMPLETELY APHAGIC AND RIGHT HEMIPLEGIC. A CLOT WAS IDENTIFIED VIA MRA IMAGING FROM BIFURCATION OF AORTA. NO H/O HYPERCOAGULABILITY. FIBROMUSCULAR HYPERPLASIA (FMH) SIGNIFICANT FOR MOTHER SUFFERING FATAL CEREBROVASCULAR ACCIDENT (CVA). REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI S SURGICAL SYSTEM.

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 ROBOTIC PROCEDURE - SMALL BOWEL RESECTION FOR FOREIGN BODY (CAMERA) OF SMALL BOWEL, POSSIBLE INFLAMMATORY MASS ON (B)(6) 2011. PER THE MEDICAL RECORDS, THE PATIENT HAD PERSISTENT ANEMIA, HAD HAD NEGATIVE WORKUP, AND THEN UNDERWENT INGESTION OF A VIDEOCAMERA IN (B)(6) 2009, BUT WAS UNABLE TO PASS THE CAMERA. AFTER SEVERAL ATTEMPTS AT THIS, SHE ELECTED TO HAVE OPERATIVE INTERVENTION. ADDITIONAL RECORDS STATE THAT THE PATIENT WAS UNABLE TO PASS THE CAPSULE AND WAS FOUND TO HAVE A SMALL AREA OF ULCERATION AND FIBROSIS. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND OTHER MEDICAL RECORDS. A CAREFUL REVIEW OF THE MEDICAL DOCUMENTATION WAS CONDUCTED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, AND/OR ACCESSORY DURING THE OPERATION. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. PERTINENT FINDINGS INCLUDE MULTIPLE AREAS OF THICKENED MESENTERY. THE SURGEON'S DICTATED OPERATIVE REPORT STATES, NEAR THE ILEOJEJUNAL JUNCTION, THERE WAS AN AREA OF SMALL BOWEL THAT HAD THICKENED MESENTERY AND FELT 2 OR 3 AREAS

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 10 DAYS AFTER A DA VINCI SI TRANSORAL RESECTION PROCEDURE WAS SUCCESSFULLY PERFORMED, THE PATIENT EXPERIENCED BLEEDING IN THE SURGICAL AREA AND EXPIRED. THE DATE OF THE SURGICAL PROCEDURE AND DATE OF DEATH WERE NOT RECEIVED. PRE SURGERY, THE PATIENT'S CANCER WAS THOUGHT TO BE AT STAGE T2, HOWEVER, DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE CANCER WAS AT STAGE T3. THERE WERE NO SYSTEM MALFUNCTIONS DURING THE PROCEDURE AND THE SURGEON INDICATED THAT THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SI SURGICAL SYSTEM. THE SURGEON BELIEVES THAT THE POST SURGICAL BLEEDING MAY HAVE BEEN RELATED TO A DELAY IN HEALING AND THAT A SCAB MAY HAVE COME OFF. THE DELAY IN REPORTING IS DUE TO A MISUNDERSTANDING ABOUT WHEN INTUITIVE SURGICAL FIRST BECAME AWARE OF 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: ON 26-NOV-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE GENERAL THORACIC AND CARDIOVASCULAR SURGERY ARTICLE TITLED, ¿IS LEFT-SIDE DAVINCI PROCEDURE CHALLENGING? INITIAL EXPERIENCES OF A SINGLE INSTITUTE.¿ WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: CASE #1 INVOLVED A 48-YEAR OLD FEMALE PATIENT WITH STAGE 1B CANCER WHO UNDERWENT A DA VINCI-ASSISTED LEFT UPPER LOBECTOMY PROCEDURE ON AN UNSPECIFIED DATE. THE CAUSE OF THE CONVERSION PER TABLE 3 IN THE ARTICLE WAS AN ¿INJURY OF PA¿ (PULMONARY ARTERY).¿IN CASE 1, THE CAUSE OF CONVERSION WAS UNCONTROLLABLE BLEEDING FROM AN INJURY TO THE LINGUAL SEGMENTAL PULMONARY ARTERY DURING STAPLING OF THE INCOMPLETE INTERLOBAR FISSURE.¿ FURTHERMORE, IT WAS NOTED IN REFERENCE TO CASE #1 (AND CASE #2) "IN BOTH CASES, CONVENTIONAL ENDOSCOPIC STAPLING DEVICES WERE EMPLOYED." ADDITIONALLY, THE ARTICLE STATES THE FOLLOWING: "WE EXPERIENCED TWO CONVERSIONS IN STAPLING THE FISSURE OF THE LEFT UPPER LOBE. BOTH CONVERSIONS WERE CAUSED BY FAILURE TO CONFIRM THAT THE TIP OF THE STAPLER WAS FREE FROM THE ADJACENT STRUCTURES. THIS IS PARTLY ATTRIBUTABLE TO THE SPECIFIC CHARACTERISTICS OF THE 30 DEGREE ANGLED SCOPE: IT IS DIFFICULT TO OBSERVE LATERALLY U