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 28-MAR-2023, INTUITIVE SURGICAL BECAME AWARE OF A JOURNAL OF BREAST CANCER ARTICLE TITLED, ¿DEVELOPMENT OF ROBOTIC MASTECTOMY USING A SINGLE-PORT SURGICAL ROBOT SYSTEM¿ (PARK, H.S., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, IT WAS MENTIONED AFTER A BILATERAL DA-VINCI ASSISTED MASTECTOMY PERFORMED ON (B)(6) 2018 ON A PATIENT WITH DUCTAL CARCINOMA IN SITU (DCIS), THERE WAS A MINOR SKIN BURN FOUND ON THE RIGHT BREAST. THERE WAS NO MENTION OF MEDICAL TREATMENT TO ADDRESS THE MINOR SKIN BURN IN THE ARTICLE. THERE WERE NO OTHER IMMEDIATE POSTOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY 15 AND DRAIN WAS REMOVED ON DAY 24. PATIENT RE-VISITED THE CLINIC ON DAY 55 BECAUSE OF REDNESS AND HEATING SENSATION OF THE RIGHT BREAST. ANTIBIOTICS AND CONSERVATIVE TREATMENT INCLUDING DRESSING AND RE-INSERTION OF THE DRAIN WERE APPLIED. HER SYMPTOMS SUBSIDED AFTER 1 DAY OF TREATMENT AND NO MAJOR SURGICAL INTERVENTION WAS NEEDED. THERE WAS NO MENTION OF ANY MALFUNCTIONS OF ANY DV SYSTEMS, INSTRUMENTS OR ACCESSORIES. FENESTRATED BIPOLAR FOCEPS (FBF) INSTRUMENT, MARLAND FORCEPS INSTRUMENT AND MONOPOLAR CURVED SCISSORS (MCS) WERE INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR(US

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 AFTER UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE A PANCREATIC FISTULA/LEAK. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THERE IS NO INDICATION OR ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON (B)(6) /2018, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION FROM A SURGEON AT A DIFFERENT HOSPITAL POSSIBLY RELATED TO THE REPORTED EVENT. THE SURGEON INDICATED THAT THE PATIENT HAD POSSIBLY EXPIRED AFTER SURGERY. THE SURGEON WAS UNABLE TO PROVIDE ANY ADDITIONAL DETAILS.

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 7 DAYS AFTER UNDERGOING A DA VINCI-ASSISTED PANCREATECTOMY (WHIPPLE) PROCEDURE, THE PATIENT ALLEGEDLY EXPIRED AS A RESULT OF A POST-OPERATIVE BLEED. POST OPERATIVELY, THE PATIENT DEVELOPED SEPSIS WITH RAISED BLOOD PRESSURE. AT THIS TIME, THE ROOT CAUSES OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS ARE UNKNOWN. ON (B)(4) 2018, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) PROVIDED ADDITIONAL INFORMATION FROM THE LEAD SURGEON REGARDING THE REPORTED ISSUE: THERE WAS NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, AND/OR ACCESSORY DURING THE SURGICAL PROCEDURE. DURING THE PROCEDURE, THE PATIENT DEVELOPED A SMALL BLEED FROM A VEIN NEAR THE BILE DUCT. THE CSR STATED THAT THERE WAS NO MEDIUM-LARGE CLIP APPLIER INSTRUMENT OR CLIPS AVAILABLE DURING THE PROCEDURE, THEREFORE, THE SURGEON USED A LARGE CLIP APPLIER INSTRUMENT. IT WAS SPECULATED BY THE LEAD SURGEON THAT THE LARGE SIZE OF THE CLIP APPLIER INSTRUMENT MIGHT HAVE CAUGHT THE VESSEL, ALLEGEDLY CAUSING THE BLEED. THE SURGEON APPLIED PRESSURE VIA A SWAB AND MORE CLIPS WERE APPLIED TO ACHIEVE HEMOSTASIS. THE PROCEDURE WAS COMPLETED ROBOTICALLY AND THE PATIENT RECOVERED WELL 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 INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR PROCEDURE, THE PATIENT EXPERIENCED AORTIC BLEEDING AND THE CASE WAS CONVERTED TO OPEN SURGERY. THE PATIENT REPORTEDLY EXPIRED IN THE INTENSIVE CARE UNIT (ICU). ON 16-NOV-2018 AND 19-NOV-2018, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE ISI CLINICAL SALES REPRESENTATIVE (CSR): THE SURGICAL PROCEDURE WAS NOT RECORDED ON VIDEO. AN ASSISTANT IN THE OPERATING ROOM (OR) REPORTEDLY INSERTED A CAMERA INCORRECTLY AND THEREFORE, VISUALIZATION WAS NOT OPTIMAL. THE CAMERA WAS INSERTED INCORRECTLY FROM THE START OF THE SURGICAL PROCEDURE. THE SITE ATTRIBUTED THE INCORRECT INSERTION OF THE CAMERA TO USER-ERROR. WHILE REPORTEDLY LOOKING FOR THE INSTRUMENTS, THE SURGEON ASSUMED SHE WAS PRESSING ON THE AORTA. THE EVENT OCCURRED WHILE THE SURGEON WAS IN THE PROCESS OF PLACING MESH AND HER HEAD WAS IN THE HIGH RESOLUTION STEREO VIEW (HRSV). THE SURGICAL STAFF INDICATED THAT THERE WAS NO DIRECT INFLUENCE OF THE DA VINCI SURGICAL SYSTEM ON THE VESSEL INJURY. AFTER THE BLEEDING WAS OBSERVED, THE CASE WAS CONVERTED TO OPEN SURGERY. THE PATIENT SUSTAINED A

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 AFTER UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE A PANCREATIC FISTULA/LEAK. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THERE IS NO INDICATION OR ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON (B)(6) 2018, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION FROM A SURGEON AT A DIFFERENT HOSPITAL POSSIBLY RELATED TO THE REPORTED EVENT. THE SURGEON INDICATED THAT THE PATIENT HAD POSSIBLY EXPIRED AFTER SURGERY. THE SURGEON WAS UNABLE TO PROVIDE ANY ADDITIONAL DETAILS.

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 08/27/2018, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE JOURNAL OF THE SOCIETY OF LAPAROENDOSCOPIC SURGEONS CLINICAL ARTICLE TITLED ¿ROBOTIC-ASSISTED TRANSTHORACIC ESOPHAGEAL DIVERTICULECTOMY¿ (BALCI ET AL., 2018). IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED ¿TRANSTHORACIC ESOPHAGEAL DIVERTICULECTOMY PROCEDURE, A PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AND SUBSEQUENTLY EXPIRED." ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT THE DA VINCI-ASSISTED SURGICAL PROCEDURE FOR A DIVERTICULUM. THE PATIENT ALSO UNDERWENT WEDGE BIOPSIES FROM THE RIGHT LUNG. THE OPERATIVE TIME WAS 165 MINUTES AND IT WAS NOTED THAT THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. ON POST-OPERATIVE DAY #2, LIQUIDS WERE STARTED AFTER NO LEAKS WERE FOUND. ON POST-OPERATIVE DAY #4, THE PATIENT HAD A FEVER OF 100.4 DEGREES FAHRENHEIT ALTHOUGH THERE WAS NO EVIDENCE OF LEAKAGE. ON POST-OPERATIVE DAY #5, THE PATIENT DEVELOPED RESPIRATORY DISTRESS IN ADDITION TO HAVING ONGOING FEVER. A CT-SCAN WAS PERFORMED FOR SUSPICION OF AN ANASTOMOTIC LEAKAGE. PLEURAL EFFUSION WAS OBSERVED IN THE RIGHT LUNG WITH FREE FLUID AND AIR IN THE OPERATIVE AREA. THE PATIENT WAS TRANSFERRED TO THE ICU AND ANTIBIOTI

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) BECAME AWARE OF AN INNOVATIONS JOURNAL ARTICLE TITLED, "EARLY CLINICAL EXPERIENCES OF ROBOTIC ASSISTED AORTIC VALVE REPLACEMENT FOR AORTIC VALVE STENOSIS WITH SUTURELESS AORTIC VALVE¿ (NAGAOKA, E. ET. AL. 2020). IN THIS ARTICLE, STUDY DATA WAS RETROSPECTIVELY COLLECTED FROM 2 PATIENTS WHO UNDERWENT DA VINCI-ASSISTED AORTIC VALVE REPLACEMENT (AVR) IN A SINGLE INSTITUTION BETWEEN MAY AND JUNE 2018. THERE WERE NO MAJOR COMPLICATIONS REPORTED AND NO CONVERSIONS TO STERNOTOMY. WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: "ONE PATIENT HAD FLUID OVERLOAD POSTOPERATIVELY DUE TO VASODILATATION AND REQUIRED AGGRESSIVE DIURESIS. OTHERWISE, POSTOPERATIVE CONVALESCENCE WAS UNCOMPLICATED. THEY WERE DISCHARGED HOME AT DAYS 4 AND 10 AFTER OPERATION, DUE TO POSTOPERATIVE ATRIAL FIBRILLATION RESPECTIVELY (TABLE 3)." ISI FOLLOWED UP WITH THE AUTHOR AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE ARTICLE: "THE POST-OPERATIVE OUTCOME WAS UNRELATED TO THE FUNCTION OF THE DA VINCI SYSTEM." HE FURTHER INDICATED THAT "THERE ARE NO SUCH ALLEGATIONS" THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE INVOLVING 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CYSTECTOMY PROCEDURE, THE PATIENT SUSTAINED AN UNSPECIFIED BOWEL INJURY. DUE TO THE INTRA-OPERATIVE COMPLICATION, THE SURGICAL PROCEDURE WAS REPORTEDLY CONVERTED TO OPEN SURGERY. ON AN UNSPECIFIED DATE, THE PATIENT REPORTEDLY EXPIRED. THE CAUSE OF THE DEATH WAS NOT PROVIDED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.