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 INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGEAL DIVERTICULUM REPAIR AND MYOTOMY PROCEDURE, THE SURGEON ALLEGEDLY HIT THE PATIENT'S AORTA AND THE CASE WAS CONVERTED TO OPEN SURGERY. THE PATIENT REPORTEDLY PASSED AWAY SHORTLY AFTER IN THE ICU. ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE REPORTED EVENT OCCURRED ABOUT AN HOUR AFTER THE SURGEON HAD BEEN SITTING AT THE SURGEON SIDE CONSOLE (SSC). AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS PERFORMING DISSECTION AND WAS USING A MARYLAND BIPOLAR FORCEPS INSTRUMENT AND A FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THERE WAS NO ALLEGATION FROM THE SURGICAL STAFF THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A DAY AFTER THE EVENT OCCURRED, THE CSR SPOKE TO THE SURGEON. THE SURGEON DID NOT PROVIDE A POSSIBLE CAUSE TO THE INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. HOWEVER, THE CSR INDICATED THAT SHE SPOKE TO A SURGICAL ASSISTANT WHO WAS PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE SURGICAL ASSISTANT INFORMED HER THAT THE SURGEON NICK

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 10/01/2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5056296 WITH THE FOLLOWING EVENT DESCRIPTION: THIS IS A LATE REPORT AS WE WERE UNAWARE WE COULD HAVE REPORTED EARLIER TO FDA. MY MOTHER, (B)(6), AT TIME OF DEATH, WAS UNDERGOING A MITRAL VALUE [SIC] REPAIR WITH THE SURGEON, DR. (B)(6) , USING THE DAVINCI ROBOT. THIS OCCURRED AT (B)(6) ON (B)(6) 2006. ACCORDING TO THE PHYSICIAN, THE ROBOT NICKED HER HEART WHICH RESULTED IN BLEEDING OUT AND EMERGENCY OPEN HEART SURGERY. SHE NEVER RECOVERED AND DEVELOPED SEPSIS INFECTION 4 DAYS LATER. WE WERE INFORMED LATER THAT OUR MOM WAS THE ONLY THE 3RD PATIENT FOR HEART VALVE SURGERY ON THIS ROBOT. WE ALSO ARE AWARE THAT ANOTHER WOMAN DIED SUBSEQUENTLY BY THE SAME ROBOT AND PHYSICIAN. THE DOCTOR LEFT TOWN AFTER THIS. (WE NEVER FILED A LAWSUIT DUE TO (B)(6) LAWS ON DAMAGES.) I AM WRITING THIS TO INFORM THE FDA AND TO NOTIFY YOU OF AN ADVERSE EVENT FOR YOUR STATS OF THIS DAVINCI ROBOT. MY HOPE IS THAT NO ONE WILL HAVE TO DIE FROM THIS ROBOT IN THE FUTURE IN THE CARDIAC REALM OF USE FOR DAVINCI. THANK YOU. (B)(6). THIS MDR ADDRESSES THE SECOND PATIENT DEATH NOTED IN THE EVENT DESCRIPTION. REFER TO THE MDR REPORT WITH PATIE

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 5. NO FURTHER CLINICAL 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 INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY PROCEDURE, THE SURGEON ENCOUNTERED A LARGE AMOUNT OF BLEEDING AND THE SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY. ACCORDING TO THE INITIAL REPORTER, IT IS UNCLEAR IF THE SURGEON TORE THE RENAL ARTERY OR ACTUALLY GOT INTO THE AORTA. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE CSR, HE WAS INFORMED BY MULTIPLE SOURCES AT THE SITE THAT THE PATIENT HAD PASSED AWAY AFTER BEING MOVED TO THE HOSPITAL FLOOR.

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 PARACOLOSTOMY HERNIA REPAIR PROCEDURE ON (B)(6) 2015. THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE PATIENT SUFFERED A PERFORATED SMALL BOWEL DURING THE SURGICAL PROCEDURE THAT WENT UNTREATED FOR SEVERAL DAYS BEFORE HIS DEATH. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY OF THE PATIENT'S MEDICAL RECORDS. ACCORDING TO THE PLAINTIFF'S ATTORNEY, THE SURGEON ENCOUNTERED MULTIPLE MASSIVE ADHESIONS DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. THE PATIENT REPORTEDLY EXPERIENCED EXCRUCIATING ABDOMINAL PAIN THAT BEGAN THE EVENING THAT THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED. THE PATIENT WAS ADMINISTERED MULTIPLE UNSPECIFIED PAIN MEDICATIONS. POST-OPERATIVELY, THE PLAINTIFF'S ATTORNEY NOTED THAT THE PATIENT DEVELOPED CLINICAL AND LABORATORY SIGNS COMMONLY REFERRED TO AS RED FLAGS THAT WERE CONSISTENT WITH PERITONITIS, SEPSIS AND SEPTIC SHOCK, INCLUDING WITHOUT LIMITATION, ABDOMINAL PAIN, ABDOMINAL TENDERNESS, INCREASED WHITE BLOOD COUNT WITH BANDEMIA, PROGRESSIVE TACHYCARDIA, PROGRESSIVE HYPOXMIA, INCREASED RESPIRATORY RATE, RESPIRATORY

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

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI ASSISTED MITRAL VALVE PROCEDURE, THE SURGEON EXPERIENCED DOUBLE VISION WITH THE 30 DEGREE ENDOSCOPE. THE INTUITIVE SURGICAL INC. (ISI)TECHNICAL SUPPORT ENGINEER (TSE) PROVIDED TROUBLESHOOTING STEPS INCLUDING ASSISTANCE IN RECALIBRATING A REPLACEMENT 30 DEGREE ENDOSCOPE; HOWEVER, THERE WAS NO CHANGE IN VISION. THE SURGEON DECIDED TO COMPLETE THE PROCEDURE USING TRADITIONAL OPEN SURGICAL TECHNIQUES. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

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

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

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE ARCHIVIO ITALIANO DI UROLOGIA E ANDROLOGIA (2015; 87, 1) JOURNAL ARTICLE TITLED, COMPARING ROBOTIC, LAPAROSCOPIC AND OPEN CYSTECTOMY: A SYSTEMATIC REVIEW AND META-ANALYSIS. (THOMAS FONSEKA ET AL., 2015). WITHIN THE ARTICLE, A STATEMENT IS NOTED ALLEGING THAT 3 PATIENTS REPORTEDLY EXPERIENCED MAJOR COMPLICATIONS AFTER UNDERGOING A DA VINCI® RADICAL CYSTECTOMY PROCEDURE AND SUBSEQUENTLY PASSED AWAY. IN THE STUDY CHARACTERISTICS SECTION, THE FOLLOWING IS STATED, 8.51% OF PATIENTS UNDERGOING RARC HAD MAJOR COMPLICATIONS WITH 3 DEATHS (0.412%) WITHIN 90 DAYS POST-OPERATIVELY.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, THE SURGEON INJURED THE PATIENT'S VENA CAVA DURING HILAR DISSECTION. THE PATIENT REPORTEDLY BLED OUT ON THE TABLE AND PASSED AWAY. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE.

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

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 HYSTERECTOMY PROCEDURE ON (B)(6) 2015 AND ALLEGEDLY SUSTAINED UNSPECIFIED DAMAGES. THE PLAINTIFF'S ATTORNEY CLAIMED THAT IMMEDIATELY FOLLOWING SURGERY, THE PATIENT DEVELOPED A CARDIOPULMONARY FAILURE AND SUFFERED FROM BLEEDING WHICH LED TO HER DEATH. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY OF THE PATIENT'S MEDICAL RECORDS.

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 MITRAL VALVE REPAIR PROCEDURE ON (B)(6) 2015 AND PASSED AWAY ON AN UNSPECIFIED DATE/TIME. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE PATIENT'S DEMISE.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DATE OF DEATH = (B)(6) 2015. THIS MDR SUBMISSION IS ACTUALLY A FOLLOW-UP #1 MDR TO MFR. REPORT # 2955842-2015-01059 (PATIENT IDENTIFIER # (B)(6)) WHICH WAS INITIALLY SUBMITTED ON 08/03/2015. ON 11/07/2018, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE DATE OF THE PATIENT'S DEMISE (NOTE: THE COMPLAINT HANDLING SYSTEM THAT WAS USED TO SUBMIT THE INITIAL MDR IS NO LONGER AVAILABLE FOR SUBMITTING EMDRS).