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 sliding hiatal hernia procedure, after sealing and cutting of an unspecified branch of the aorta, bleeding occurred and the patient ultimately expired.The surgeon reported that the Vessel Sealer Curved (VSC) instrument seal and cut cycle worked as expected with no error messages. However, when the jaws of the VSC were opened, the sealed branch started to hemorrhage. The procedure continued robotically for approximately one hour in attempts to fully stop the bleeding which was able to be controlled at multiple points after the initial seal. The estimated blood loss during the robotic portion was approximately 2 liters when a mass transfusion protocol was initiated and the procedure was converted to a thoracotomy but the surgeon was unable to control the bleeding. The aorta was then cross-clamped and the bleeding stopped; however, the patient expired in the operating room. The surgeon reports there were no error messages or robotic-related complications that occurred during the procedure. Specifically, the VSC worked as expected with no error messages or complications with sealing during use.

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 UNSPECIFIED COLORECTAL PROCEDURE, THE INFERIOR MESENTERIC ARTERY (IMA) WAS SEALED WITH THE VESSEL SEALER CURVED (VSC) INSTRUMENT AND BLEEDING OCCURRED AFTER SEALING AND CUTTING. THE PATIENT LATER EXPIRED ON POSTOPERATIVE DAY 3. THE SURGEON REPORTED THAT WHEN THE JAWS WERE OPENED, BLEEDING WAS IMMEDIATE. THE IMA HAD AN OPEN LUMEN AND SHOWED NO SIGNS OF SEALING. THE VSC CONTINUED TO BE USED TO SEAL THE IMA TWO MORE TIMES ALONG DIFFERENT POINTS DURING THE PROCEDURE; BLEEDING OCCURRED AFTER EACH SEAL. THE VESSEL HAD TO BE RE-SEALED MORE PROXIMALLY TOWARD THE AORTA TO MOBILIZE THE TISSUE TO CREATE AN OSTOMY. THE SEALING TONES WERE REPORTED AS APPROPRIATE AND NO ERROR MESSAGES WERE PRODUCED WHILE SEALING. THE ESTIMATED BLOOD LOSS WAS 300ML. AFTER THE ROBOTIC PORTION WAS COMPLETED AND DURING CLOSURE, THE PATIENT CODED. RESUSCITATION MEASURES WERE SUCCESSFUL, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT EXPIRED THREE DAYS LATER AFTER THE FAMILY DECIDED TO WITHDRAW CARE. THE SURGEON RELATED THE VSC INABILITY TO SUCCESSFULLY SEAL MULTIPLE TIMES THROUGHOUT THE PROCEDURE TO CHALLENGING TISSUE INTEGRITY DUE TO EDEMA. 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 MEDIAN ARCUATE LIGAMENT SYNDROME RELEASE (MALS) PROCEDURE, THE PATIENT EXPERIENCED INTRAOPERATIVE BLEEDING FROM THE AORTA AND ULTIMATELY EXPIRED. THE VESSEL SEALER CURVED (VSC) INSTRUMENT WAS BEING USED FOR BLUNT DISSECTION AND CAUTERY WHEN SIGNIFICANT BLEEDING OCCURRED FROM THE AORTA. THE PROCEDURE WAS EMERGENTLY CONVERTED TO AN OPEN APPROACH. WHEN AN ASSISTING VASCULAR SURGEON CROSS CLAMPED THE AORTA DURING REPAIR ATTEMPTS, THE PATIENT¿S PULSE WAS LOST AND CHEST COMPRESSIONS WERE STARTED. WITH NO RETURN OF A PULSE, THE CROSS CLAMPS ON THE AORTA WERE REMOVED AND BLEEDING CONTINUED WITH THE CHEST COMPRESSIONS. THE PATIENT EXPIRED IN THE OPERATING ROOM. THE SURGEON STATED THAT THE CAUSE OF THE AORTIC INJURY WAS UNKNOWN. THE SURGEON REPORTED THAT THROUGHOUT THE PROCEDURE, IT WAS NOTICED THAT THE VSC PRODUCED INCREASED THERMAL SPREAD AND INCREASED BLEEDING AFTER ENERGY ACTIVATION WHEN COMPARED TO THE VESSEL SEALER EXTEND. IT WAS ALSO STATED THAT THE VSC JAW MOVEMENT WOULD OPEN A LITTLE SLOWLY AT FIRST, THEN WOULD SPRING OPEN QUICKLY, WITH INCREASED BLEEDING FROM THE FAST JAW OPENING. NO ADDITIONAL INFORMATION 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: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SINGLE-PORT UNSPECIFIED ¿HEAD AND NECK¿ SURGICAL PROCEDURE, THE PATIENT DEVELOPED A POSTOPERATIVE HEMORRHAGE AND ULTIMATELY EXPIRED. THE SURGEON INFORMED THE INTUITIVE CLINICAL SALES REPRESENTATIVE THAT THE ROBOTIC PROCEDURE WAS COMPLETED WITHOUT ANY INTRAOPERATIVE COMPLICATIONS; HOWEVER, THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS DUE TO UNSPECIFIED BLEEDING FROM THE NON-SPECIFIC PROCEDURE. NO ADDITIONAL EVENT INFORMATION WAS PROVIDED. THE SURGEON STATED THAT THE ADVERSE EVENT ¿HAD NOTHING TO DO WITH THE DA VINCI SP SYSTEM¿. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SURGEON WERE MADE; HOWEVER, NO RESPONSE WAS 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, AN INADVERTENT PERFORATION OF THE PULMONARY ARTERY OCCURRED WHILE USING A THIRD-PARTY LAPAROSCOPIC STAPLER INSTRUMENT, RESULTING IN SIGNIFICANT HEMORRHAGE AND THE PATIENT ULTIMATELY EXPIRED. THE EXACT VOLUME OF BLOOD LOSS IS UNKNOWN. THE SURGEON DOES NOT BELIEVE THAT THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT THE CUSTOMER HAS INDICATED THAT THEY WILL NOT GRANT PERMISSION FOR FURTHER ACCESS TO THE EVENT INFORMATION.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF AN ARTICLE WAS CONDUCTED, WHICH AIMED TO EVALUATE THE INITIAL EXPERIENCE AND FEASIBILITY OF ROBOTIC-ASSISTED PYLORUS-PRESERVING PANCREATICODUODENECTOMY PROCEDURES (PPPD) USING THE DA VINCI SP SYSTEM VERSUS THE DA VINCI XI SYSTEM. THE STUDY WAS A RETROSPECTIVE CASE SERIES ANALYZING 14 PATIENTS UNDERGOING PPPD FROM DECEMBER 2021 AND SEPTEMBER 2023. ONE PATIENT WITH COMMON BILE DUCT CANCER DIED DURING AT AN UNSPECIFIED TIME POST-PROCEDURE DUE TO THE PROGRESSION OF CANCER. THERE WAS NO REPORT OR INDICATION IN THE ARTICLE OF ANY DA VINCI SP SYSTEM MALFUNCTIONS. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CORRESPONDING AUTHOR WERE MADE; HOWEVER, NO RESPONSE HAS BEEN 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: A REVIEW OF AN ARTICLE WAS PERFORMED THAT EVALUATED OUTCOMES OF ROBOTIC INGUINAL HERNIA REPAIR (RIHR) IN A SINGLE INSTITUTION STUDY COMPARING SURGEONS WITH VARYING ROBOTIC EXPERIENCE. THE STUDY ANALYZED 297 PATIENTS UNDERGOING ROBOTIC INGUINAL HERNIA REPAIR BETWEEN JULY 2016 AND SEPTEMBER 2021. ONE PATIENT DIED WITHIN 30 DAYS POST SURGERY DUE TO ASPIRATION PNEUMONIA LEADING TO CARDIAC ARREST. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY ISI DEVICE. INTUITIVE SURGICAL INC, (ISI) CONTACTED THE AUTHOR WHO REPORTED THAT THERE WERE NO ISSUES SEEN OR RECORDED WITH THE DA VINCI SYSTEM DURING THE STUDY. THE SYSTEM ITSELF DID NOT CONTRIBUTE TO THE DEATH IN THE STUDY WHICH WAS RELATED TO THE PATIENTS CO MORBIDITY AND NOT THE SURGERY ITSELF.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF THE CLINICAL ARTICLE WAS CONDUCTED, WHICH SUMMARIZED THE CLINICAL EXPERIENCE AND OUTCOMES OF TRANSORAL ROBOTIC SURGERY (TORS) IN THE TREATMENT OF HYPOPHARYNGEAL CARCINOMA. THE RETROSPECTIVE MULTICENTER STUDY ANALYZED 28 PATIENTS (ALL MALE, AGED 47- 82 YEARS) UNDERGOING TRANSORAL ROBOTIC SURGERY USING THE DA VINCI SI OR XI SURGICAL SYSTEM BETWEEN SEPTEMBER 2017 AND MARCH 2024. THE ARTICLE REPORTED TWO POSTOPERATIVE DEATHS WITHIN ONE MONTH OF SURGERY WITHOUT ANY OTHER DETAILS. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY THE DA VINCI SURGICAL SYSTEM. REQUESTS FOR ADDITIONAL INFORMATION WERE MADE TO THE CORRESPONDING AUTHOR, BUT NO RESPONSE HAS BEEN 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MEDIASTINAL MASS RESECTION, THE BRACHIOCEPHALIC ARTERY WAS INJURED AND THE PROCEDURE WAS CONVERTED TO OPEN. THE PATIENT EXPIRED ON POST-OPERATIVE DAY ONE. THE SURGEON REPORTED THAT THE ARTERY WAS INJURED WHEN USING THE SYNCHROSEAL INSTRUMENT TO DISSECT LYMPH NODES. THE ARTERY WAS ADHERED TO TISSUE AND TO THE LYMPH NODES, RESULTING IN THE ARTERY NOT BEING VISIBLE TO THE SURGEON. THE ARTERY BEGAN TO BLEED AFTER IT WAS GRASPED WITH THE SYNCHROSEAL INSTRUMENT. THE PROCEDURE WAS CONVERTED TO THORACOTOMY. THERE WAS NO MALFUNCTION OF THE SYNCHROSEAL INSTRUMENT OR ANY OTHER DA VINCI PRODUCTS USED DURING THIS PROCEDURE. NO ADDITIONAL INFORMATION 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: DRS. (B)(6), PLEASE NOTE, MS. (B)(6), WHO DIED WITHIN ONE YEAR FOLLOWING ROBOTIC MASTECTOMY FOR STAGE 2 BREAST CANCER: PLEASE NOTE - MS. (B)(6) CASE WAS ADVERTISED AS THE FIRST ROBOTIC MASTECTOMY OPERATION PERFORMED IN THE U.S. FOR TREATMENT OF BREAST CANCER: PLEASE NOTE, 5-YR SURVIVAL RATES FOR STAGE 2 BREAST CANCER USING THE CONVENTIONAL APPROACH TO MASTECTOMY IS OVER 80%. MS. (B)(6) DIED WITHIN ONE YEAR OF HER ROBOTIC MASTECTOMY SURGERY. PLEASE ENSURE THAT INTUITIVE SURGICAL HAS FORMALLY REPORTED THIS PATIENT MORTALITY FOLLOWING HER ROBOTIC MASTECTOMY TO THE FDA. ON JAN 5, 2025, AT 11:37 PM, (B)(6) WROTE: DRS. (B)(6), I AM WRITING THIS LETTER OF SAFETY AND ETHICS CONCERN/WARNING TO YOU BASED ON THE TWO RECENT HUMAN SUBJECT RESEARCH PUBLICATIONS FROM SOUTH KOREA, WHICH WERE SUPPORTED BY INTUITIVE SURGICAL: HTTPS://JAMANETWORK.COM/JOURNALS/JAMASURGERY/FULLARTICLE/2822315, HTTPS://WWW.NATURE.COM/ARTICLES/S41598-024-84807-0. THESE STUDIES INVOLVE THE USE OF THE DA VINCI ROBOTIC SYSTEM TO PERFORM MASTECTOMIES ON PATIENTS WITH BREAST CANCER, WHICH AS YOU KNOW WELL, IS CONSIDERED A NON-STANDARD AND OFF-LABEL APPROACH IN THE US AND WESTERN EUROPE. ADDITIONALLY, THESE EXPERIMENTAL SURGER

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 PANCREATODUODENECTOMY PROCEDURE, AN UNSPECIFIED VESSEL WAS DAMAGED LEADING TO BLEEDING. THE PROCEDURE WAS CONVERTED TO OPEN; THE PATIENT ULTIMATELY EXPIRED. AN INTUITIVE CLINICAL TERRITORY ASSOCIATE (CTA) WHO WAS PRESENT IN THE OR DURING THE PROCEDURE REPORTED THAT WHEN THE INJURY TO THE VESSEL OCCURRED, THE SURGEON CLAMPED THE BLEEDING VESSEL WITH A ROBOTIC INSTRUMENT. THE SURGEON STATED THAT DURING THE OPEN PROCEDURE THEY COULD NOT OBTAIN FULL CONTROL OF THE BLEEDING. CHEST COMPRESSIONS WERE PERFORMED, BUT THE PATIENT EXPIRED ON THE OR TABLE. THE SURGEON STATED THAT, "THE COMPLICATION WAS NOT RELATED TO THE DEVICES BUT TO [THE] COMPLEXITY OF THE SURGERY AND DEGREE OF CANCER." COINCIDENTALLY, PRIOR TO THE VESSEL INJURY EVENT, THE CTA CALLED INTUITIVE TECHNICAL SUPPORT ENGINEERING (TSE) TO REPORT THAT WHEN SWAPPING INSTRUMENTS, THE UNIVERSAL SURGICAL MANIPULATOR 3 (USM ARM3) WOULD JUMP MORE THAN NORMAL AND WOULD CANCEL GUIDED TOOL CHANGE (GTC). THE (TSE) REVIEWED THE SYSTEM LOGS AND FOUND NO RELATED ERRORS AT THE TIME OF THE CALL. THE CTA ALSO REPORTED A SYNCHROSEAL INSTRUMENT IN USE ON USM ARM3 COULD ONLY ROTATE TO THE RIGHT. THE TSE

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 25-30 MINUTES INTO A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY PROCEDURE, THE PATIENT EXPERIENCED HEMODYNAMIC INSTABILITY WITH A DROP IN BLOOD PRESSURE AND HYPOXIA. THE CARDIAC ANESTHESIOLOGIST PERFORMED A TRANSESOPHAGEAL ECHOCARDIOGRAM AND A CO2 GAS EMBOLUS WAS OBSERVED IN THE RIGHT VENTRICLE. THE SURGICAL FELLOW REPORTED THAT THE PATIENT WAS IN A TRENDELENBURG POSITION OF APPROXIMATELY 10 DEGREES AND THE 3RD PARTY INSUFFLATION DEVICE PRESSURE WAS SET TO 12 MMHG. THE PROCEDURE WAS ABORTED; THEY WERE AT THE PROSTATE ENUCLEATION STEP WITH APPROXIMATELY ANOTHER 15-20 MINUTES REMAINING IN THE PROCEDURE. THE PATIENT DECOMPENSATED A SECOND TIME IN THE INTENSIVE CARE UNIT AND EXPIRED ABOUT 4-5 HOURS POST-OPERATIVELY. THE PATIENT HAD A HISTORY OF CARDIAC COMORBIDITIES. THE REPORTED CAUSE OF DEATH WAS CO2 EMBOLUS AND MYOCARDIAL INFARCTION. THE FELLOW STATED THAT THE EVENT WAS NOT CAUSED BY ANY DA VINCI PRODUCT; IT WAS A COMBINATION OF THE PRE-EXISTING CARDIAC CONDITION AND ABSORPTION OF CO2 GAS.

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-ASSISTED RADICAL PROSTATECTOMY PROCEDURE, THE PATIENT DIED OF A PULMONARY EMBOLISM ON AN UNSPECIFIED DATE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS AND THE PATIENT HAD A FAST INITIAL POST-OPERATIVE RECOVERY. THE SURGEON AND THE HOSPITAL TEAM DO NOT THINK THIS IS DIRECTLY RELATED TO THE DA VINCI SINGLE PORT (SP) SYSTEM USED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE SURGEON AND A RESPONSE IS PENDING.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE THAT DESCRIBED A COHORT STUDY OF 2225 PATIENTS THAT UNDERWENT ROBOT-ASSISTED SURGERY (RAS) IN GYNECOLOGICAL ONCOLOGY FROM JANUARY 2015 TO DECEMBER 2022. THE AIM OF THE STUDY WAS TO PROVIDE A COMPREHENSIVE DESCRIPTION OF PERIOPERATIVE MORBIDITY ASSOCIATED WITH ROBOT-ASSISTED SURGERY (RAS) IN GYNECOLOGICAL ONCOLOGY TO ENHANCE PREOPERATIVE COUNSELING AND SUPPORT SHARED DECISION-MAKING. A GYNECOLOGICAL ONCOLOGIST PERFORMED THE SURGERY IN 98% OF THE CASES, AND 64% OF THESE SURGEONS WERE ALREADY EXPERIENCED IN RAS (>50 ROBOTIC PROCEDURES). THE DA VINCI SI SYSTEM WAS USED IN 524 CASES AND THE DA VINCI XI SYSTEM IN 1701 CASES. AMONG THE 2225 PATIENTS, THE ARTICLE NOTED THAT ONE PATIENT DIED DUE TO CARDIOGENIC SHOCK 2 WEEKS AFTER UNCOMPLICATED RAS, THE CAUSE OF DEATH WAS FOUND TO BE MAJOR THROMBOEMBOLIC EVENT (TEE). THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHORS ALLEGE THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENTS. THE STUDY CONCLUDED THAT RAS IN A HIGH-VOLUME GYNECOLOGICAL ONCOLOGY SETTING RESULTED IN LOW RATES OF MAJOR PERIOPERATIVE MORBIDITY AND CONVERSION TO LAPAROTOMY. THE FINDINGS SUPPORT THE USE OF RAS FOR SUITABLE PATIEN

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE ANALYSIS BETWEEN 2011-2022 OF 184 PATIENTS THAT UNDERWENT DA VINCI ASSISTED TORS SURGERY WITH NECK DISSECTION IN ONE SINGLE INSTITUTION, PERFORMED BY TWO TRAINED SURGEONS. THE STUDY WAS CONDUCTED TO EVALUATE THE ONCOLOGICAL OUTCOMES OF POST-TRANSORAL ROBOTIC SURGERY (TORS) FOR HPV-ASSOCIATED OROPHARYNGEAL SQUAMOUS CELL CARCINOMA. THE 3-YEAR AND 5-YEAR DISEASE-SPECIFIC SURVIVAL WERE 98.6% (95% CI 96.7¿100%) AND 94.4% (95% CI 89.9¿99.0%), RESPECTIVELY. THREE PATIENTS DIED FROM CAUSES UNRELATED TO DISEASE RECURRENCE. ONE PATIENT (0.5%) HAD AN EARLY POSTOPERATIVE HEMORRHAGE, DEFINED BY BLEEDING OCCURRING LESS THAN 24 HOURS FOLLOWING SURGERY, RESULTING IN DEATH FOUR DAYS LATER. ONE PATIENT DIED FROM CARDIOPULMONARY ARREST; ANOTHER PATIENT DIED FROM A SECOND TUMOR METASTASIS. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE HAS BEEN 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: REVIEW OF AN ARTICLE WAS COMPLETED OF A RANDOMIZED CONTROLLED TRIAL BASED ON DA VINCI-ASSISTED ROBOTIC PANCREATICODUODENECTOMY (RPD) WHERE THE AUTHORS COMPARED THE SHORT-TERM POSTOPERATIVE OUTCOMES OF RPD WITH THOSE OF OPEN PANCREATICODUODENECTOMY (OPD). THE TRIAL, CONDUCTED BETWEEN MARCH 5 AND DECEMBER 20, 2022, INCLUDED 164 PATIENTS RANDOMLY ASSIGNED TO EITHER THE RPD OR OPD GROUP. IN THE RPD GROUP, THERE WAS ONE IN-HOSPITAL DEATH (1%) WITHIN 90 DAYS AFTER THE OPERATION. SPECIFICALLY, ONE (1%) OF 81 PATIENTS IN THE RPD GROUP DEVELOPED POSTOPERATIVE PANCREATIC FISTULA RELATED HEMORRHAGE ON POSTOPERATIVE DAY 9, UNDERWENT TRANS-ARTERIAL EMBOLIZATION AND A SUBSEQUENT REOPERATION, BUT DIED OF SEPTIC SHOCK ON DAY 30. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED. THE OPD SUBSET ALSO HAD ONE PATIENT DEATH DUE TO A PULMONARY EMBOLISM ON POSTOPERATIVE 5. THE ARTICLE STATES THAT WHILE RPD SHOWED BENEFITS IN REDUCING HOSPITAL STAY, THE OVERALL CLINICAL BENEFIT REMAINS UNCLEAR, ESPECIALLY CONSIDERING THE EXTRA COSTS AND PATIENT PERCEPTIONS OF QUALITY OF LIFE AND RECOVERY AFTER DISCHARGE.

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 THE PATIENT UNDERWENT AN UNEVENTFUL DA VINCI ASSISTED LOW ANTERIOR RESECTION FOR COLORECTAL CANCER. THE SURGEON STATED THAT THE ANASTOMOSIS WAS END-TO-END, CREATED WITH AN ETHICON ILS 29 CIRCULAR STAPLER. TESTING OF THE ANASTOMOSIS WAS PERFORMED DURING THE OPERATION AND NO LEAKAGE WAS FOUND. THE PATIENT EXPERIENCED COMPLICATIONS POSTOPERATIVELY AND EXPIRED APPROXIMATELY 69 DAYS POST-PROCEDURE. THERE WAS NO REPORT OF ANY ISSUES WITH THE DAVINCI PRODUCTS. ON POST-OPERATIVE DAY 4 (POD) THE PATIENT'S BLOOD PRESSURE SIGNIFICANTLY DROPPED AND CT SCANS SHOWED PNEUMOPERITONEUM. ANASTOMOSIS LEAKAGE, PERITONITIS, AND SEPSIS WERE SUSPECTED AND AN EMERGENT RE-OPERATION WAS PERFORMED. THE PATIENT REQUIRED POST-OPERATIVE CIRCULATORY AND OXYGEN SUPPORT VIA VENO-ARTERIAL AND VENO-VENO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND VASOPRESSORS DUE TO RESPIRATORY FAILURE AND SEPTIC SHOCK. ON POD 7 THE CIRCULATORY SUPPORT WAS CHANGED TO VENO-VENOUS ECMO ONLY, WHICH WAS REMOVED FIVE DAYS LATER AFTER THE PATIENT WAS HEMODYNAMICALLY STABLE. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR ILEOSTOMY AND WOUND INFECTIONS. THE PATIENT'S HAND BECAME CYANOTIC FROM THE ECMO TREATMENT REQUIRI

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING INVESTIGATION OF AN UNRELATED EVENT, A SURGEON NOTIFIED AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE THAT THE COUNTY MEDICAL EXAMINER (ME), WHILE PROVIDING AUTOPSY RESULTS FOR THE UNRELATED EVENT, "RECALLED TWO PREVIOUS PATIENT DEATHS CAUSED BY ROBOTIC STAPLE LINES NOT HOLDING UP ON ARTERIES AND CAUSING BLEEDING." THE ME RECALLED THAT ONE PATIENT HAD RECEIVED A ROBOTIC-ASSISTED PROSTATECTOMY, AND THE OTHER PATIENT RECEIVED A ROBOTIC-ASSISTED SPLENECTOMY. THERE WAS NO ADDITIONAL INFORMATION EXCHANGED, OTHER THAN THE EVENTS OCCURRED AT DIFFERENT HOSPITALS. THE MEDICAL EXAMINERS OFFICE WAS CONTACTED TO REQUEST ADDITIONAL INFORMATION. THE ME ASSISTANT STATED THEY WOULD REVIEW PREVIOUS CASES TO DETERMINE IF THERE WERE ANY SIMILAR CASES. UPON FOLLOW UP, THE ME ASSISTANT REPORTED FINDING A PROSTATECTOMY CASE FROM 2015, AND THE ONLY INFORMATION THEY COULD SHARE WAS THE DATE OF DEATH AND HOSPITAL WHERE THE PROCEDURE WAS PERFORMED. THERE WERE NO SIMILAR SPLENECTOMY CASES FOUND IN THE MEDICAL EXAMINERS RECORDS. THE MEDICAL EXAMINER DECLINED TO PROVIDE ANY FURTHER INFORMATION AND DESCRIBED THE CONVERSATION AS A BRIEF COLLEAGUE-TO-COLLEAGUE OBSERVATION. NO ADDITIONAL 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 DURING A DA VINCI ASSISTED HIATAL HERNIA REPAIR, THE INFERIOR VENA CAVA (IVC) WAS INJURED. THE SURGEON REPORTED THAT THE INJURY OCCURRED DUE TO ATYPICAL ANATOMY. WHILE USING THE HARMONIC ACE SHEARS TO DIVIDE THE GASTROHEPATIC LIGAMENT, A MALPOSITION OF THE IVC RELATIVE TO ITS NORMAL POSITION WAS ENCOUNTERED. THE IVC WAS TENSELY PULLED ACROSS THE DIAPHRAGM AND UNRECOGNIZED AS IT WAS TUCKED RIGHT BEHIND THE GASTROHEPATIC LIGAMENT. THE SURGEON BELIEVES THE SIDEWALL OF THE IVC WAS UNKNOWINGLY GRASPED IN THE INSTRUMENT JAWS WHILE DIVIDING THE LIGAMENT. THE PROCEDURE WAS CONVERTED TO OPEN TO ADDRESS THE INJURY, BUT THE PATIENT EXPIRED. THERE WAS NO REPORTED INTUITIVE SURGICAL, INC. (ISI) PRODUCT MALFUNCTION.

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-ASSISTED HYSTERECTOMY PROCEDURE ON AN UNSPECIFIED DATE AND DIED FROM CANCER IN 2016. ACCORDING TO THE INITIAL REPORTER, THE PATIENT'S TREATMENT WAS NEGATIVELY AFFECTED BY THE DA VINCI-ASSISTED SURGERY. THE INITIAL REPORTER INDICATED THAT THE PATIENT UNDERWENT THE HYSTERECTOMY FOR CANCER THAT REOCCURRED FOR A SECOND TIME. PER THE INITIAL REPORTER, IT IS BELIEVED THAT THE ROBOTIC PROCEDURE "STIRRED UP THE CANCER" AND EXPEDITED HER DEATH BY SPREADING. THE PATIENT REPORTEDLY DIED WITHIN SIX MONTHS OF THE SURGERY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE 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: ON 02-APR-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A "JORNAL BRASILEIRO DE PNEUMOLOGIA" ARTICLE TITLED, ¿ROBOTIC THORACIC SURGERY FOR NON-SMALL CELL LUNG CANCER: INITIAL EXPERIENCE IN BRAZIL¿ (TERRA, R. M., BIBAS, B. J., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED. IT WAS NOTED THAT A ¿PROCEDURE-RELATED DEATH OCCURRED IN 1 PATIENT (0.5%), 12 DAYS AFTER A LOBECTOMY. THAT PATIENT HAD DEVELOPED PNEUMONIA, SEPSIS, AND MULTIPLE ORGAN FAILURE.¿ THE ARTICLE CORRESPONDENT WAS CONTACTED TO GATHER ADDITIONAL INFORMATION AND THE INFORMATION WAS RECEIVED: THE ARTICLE CORRESPONDENT STATED THAT THERE WERE NO ALLEGATIONS OR CLAIMS THAT A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. THE ARTICLE CORRESPONDENT ALSO STATED THAT "THE PROCEDURE-RELATED DEATH WAS ONE CASE IN WHICH THE PATIENT COURSED WITH PNEUMONIA AFTER THE PROCEDURE. NOTHING RELATED TO THE ACCESS ROUTE OR DA VINCI 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: IT WAS INITIALLY REPORTED THAT AFTER UNDERGOING TWO UNSPECIFIED SURGICAL PROCEDURES INVOLVING THE PROSTATE, TWO PATIENTS SUBSEQUENTLY CONTRACTED COVID-19 AND EXPIRED. PRIOR TO UNDERGOING THE SURGICAL PROCEDURES, THE PATIENTS HAD TESTED NEGATIVE FOR COVID-19 PRIOR TO THE PROCEDURE. THE INITIAL REPORTER COULD NOT CONFIRM IF THE PROCEDURES IN QUESTION INVOLVED THE USE OF A DA VINCI SURGICAL SYSTEM. IN ADDITION, THE INITIAL REPORTER ALSO DID NOT WHAT HOSPITAL(S) OR SURGEON(S) WERE INVOLVED. ON 04-MAY-2020, THE INITIAL REPORTER WAS CONTACTED AND THE FOLLOWING INFORMATION WAS OBTAINED: THE INITIAL REPORTER DISCUSSED THE SURGERIES WITH REPORTING PROFESSOR/SURGEON ON 29-APR-2020. THE TWO SURGERIES WERE PROSTATECTOMIES; HOWEVER, IT IS UNKNOWN WHETHER A DA VINCI SYSTEM WAS EVEN USED FOR EITHER SURGERY. THE REPORTING PROFESSOR/SURGEON WAS UNABLE TO PROVIDE THE ASSOCIATED HOSPITAL(S) OR SURGEON NAME(S) AS HE DOES NOT REMEMBER BECAUSE IT WAS SECONDHAND INFORMATION. THE REPORTING PROFESSOR/SURGEON BROUGHT THESE CASES UP DURING A CONVERSATION ABOUT FAULTY COVID-19 TEST RESULTS. THE REPORTING PROFESSOR/SURGEON STATED THAT IT IS UNKNOWN WHETHER THE TWO PATIENTS HAD RECEIVED FALSE NEGATIVE TESTS PRI

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 14-MAY-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A HEAD & NECK ARTICLE TITLED, ¿ONE-YEAR OUTCOMES FOR DA VINCI SINGLE PORT ROBOT FOR TRANSORAL ROBOTIC SURGERY¿ (VAN ABEL, K. M., YIN, L. X., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED. WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: ¿THERE WERE 4 POSTOPERATIVE HEMORRHAGES FOR AN OVERALL BLEED RATE OF 5.1%. THE DETAILS ON THESE POSTOPERATIVE HEMORRHAGE EVENTS ARE REPORTED IN TABLE 3. THERE WERE TWO MORTALITIES IN THIS COHORT OF 78, ONE SECONDARY TO A POST-TONSILLECTOMY HEMORRHAGE AND ANOTHER SECONDARY TO A POSTOPERATIVE PULMONARY EMBOLUS, FOR AN OVERALL MORTALITY RATE OF 2.6%¿ PROCEDURE INFORMATION PROCEDURE CATEGORY PROCEDURE NAME TRANSORAL ROBOTIC SURGERY. ISI FOLLOWED-UP WITH THE AUTHOR, WHO STATED THE FOLLOWING REGARDING THE REPORTED COMPLICATIONS: THERE WAS NO ALLEGATION OR CLAIM THAT A MALFUNCTION OF THE SYSTEM OR INSTRUMENT WAS INVOLVED IN THESE COMPLICATIONS. "THESE ARE KNOWN RISKS WITH THIS SURGICAL PROCEDURE, DOCUMENTED WITH THE SI AND TRANSORAL LASER MICROSURGERY AS WELL. WE DID NOT IDENTIFY A RATE HIGHER THAN THE PUBLISHED AVERAGES." NOTE

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 14-MAY-2020, INTUITIVE BECAME AWARE OF A HEAD & NECK ARTICLE TITLED, ¿ONE-YEAR OUTCOMES FOR DA VINCI SINGLE PORT ROBOT FOR TRANSORAL ROBOTIC SURGERY¿ (VAN ABEL, K. M., YIN, L. X., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED. WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: ¿THERE WERE 4 POSTOPERATIVE HEMORRHAGES FOR AN OVERALL BLEED RATE OF 5.1 %. THE DETAILS ON THESE POSTOPERATIVE HEMORRHAGE EVENTS ARE REPORTED IN TABLE 3. THERE WERE TWO MORTALITIES IN THIS COHORT OF 78, ONE SECONDARY TO A POST-TONSILLECTOMY HEMORRHAGE AND ANOTHER SECONDARY TO A POSTOPERATIVE PULMONARY EMBOLUS, FOR AN OVERALL MORTALITY RATE OF 2.6%¿ PROCEDURE INFORMATION PROCEDURE CATEGORY PROCEDURE NAME TRANSORAL ROBOTIC SURGERY. THE ARTICLE¿S CONCLUSION CONTAINS THE FOLLOWING: ¿THERE WERE NO COMPLICATIONS DIRECTLY RELATED TO THE ROBOTIC PLATFORM, MAKING THE SP A SAFE SURGICAL INSTRUMENT FOR UPPER AERODIGESTIVE TRACT TUMORS. ALTHOUGH THE NEW SYSTEM POSED UNIQUE TECHNICAL CHALLENGES, THE OVERALL LEARNING CURVE FOR THE SP WAS RAPID AMONG EXPERIENCED TORS SURGEONS.¿ INTUITIVE SURGICAL, INC. (ISI) FOLLOWED-UP WITH THE AUTHOR WHO STATED THE FOLLO

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 TWO UNSPECIFIED SURGICAL PROCEDURES INVOLVING THE PROSTATE, TWO PATIENTS SUBSEQUENTLY CONTRACTED COVID-19 AND EXPIRED. PRIOR TO UNDERGOING THE SURGICAL PROCEDURE, THE PATIENTS HAD TESTED NEGATIVE FOR COVID-19 PRIOR TO THE PROCEDURE. THE INITIAL REPORTER COULD NOT CONFIRM IF THE PROCEDURES IN QUESTION INVOLVED THE USE OF A DA VINCI SURGICAL SYSTEM. IN ADDITION, THE INITIAL REPORTER ALSO DID NOT WHAT HOSPITAL(S) OR SURGEON(S) WERE INVOLVED. ON 04-MAY-2020, THE INITIAL REPORTER WAS CONTACTED AND THE FOLLOWING INFORMATION WAS OBTAINED: THE INITIAL REPORTER DISCUSSED THE SURGERIES WITH THE REPORTING PROFESSOR/SURGEON ON (B)(6) 2020. THE TWO SURGERIES WERE PROSTATECTOMIES; HOWEVER, IT IS UNKNOWN WHETHER A DA VINCI SYSTEM WAS EVEN USED FOR EITHER SURGERY. THE REPORTING PROFESSOR/SURGEON WAS UNABLE TO PROVIDE THE ASSOCIATED HOSPITAL(S) OR SURGEON NAME(S) AS HE DOES NOT REMEMBER BECAUSE IT WAS SECONDHAND INFORMATION. THE REPORTING PROFESSOR/SURGEON BROUGHT THESE CASES UP DURING A CONVERSATION ABOUT FAULTY COVID-19 TEST RESULTS. THE REPORTING PROFESSOR/SURGEON STATED THAT IT IS UNKNOWN WHETHER THE TWO PATIENTS HAD RECEIVED FALSE NEGATIVE TESTS

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 INITIAL ENTRY WITH AN INTUITIVE SURGICAL, INC. (ISI) TROCAR AND OBTURATOR AT THE START OF A VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT EXPERIENCED BLEEDING. THE PROCEDURE WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE TO IDENTIFY THE SOURCE OF THE BLEEDING. THREE OTHER SURGEONS WERE ASKED TO ASSIST WITH FINDING THE SOURCE OF THE BLEEDING. HOWEVER, THE SURGEONS COULD NOT IDENTIFY THE INJURED VESSEL, AND THE PATIENT REPORTEDLY EXPIRED. ISI CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: IN AN ATTEMPT TO GAIN INITIAL ACCESS TO THE ABDOMINAL CAVITY, THE SURGEON INSERTED AN ISI 8MM TROCAR IN THE LEFT UPPER QUADRANT UNDER DIRECT VISUALIZATION. THE ABDOMINAL CAVITY WAS NOT SUCCESSFULLY ENTERED DURING THE FIRST ATTEMPT AS THE SURGEON ONLY SAW FAT. DURING THE SECOND ATTEMPT, THE SURGEON AGAIN FAILED TO GAIN ACCESS. HOWEVER, AFTER THE SECOND ATTEMPT TO GAIN ACCESS, BLOOD WAS SEEN ALONG WITH FAT. THE SURGEON WAS NOT SURE IF THERE WAS ANY MISIDENTIFICATION OF ANATOMY DUE TO THE AMOUNT OF FAT. THE ANESTHESIOLOGIST STATED THAT THE BLOOD PRESSURE WAS INITIALLY STABLE. THE SURGEON THEN CONVERTED TO AN OPEN SURGICAL

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 PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE THAT THE PATIENT'S LUNG CAPACITY STARTED TO DETERIORATE. THE PATIENT THEN EXPERIENCED AN UNSPECIFIED CARDIAC EVENT AND CODED. THE DA VINCI SYSTEM WAS UNDOCKED FROM THE PATIENT TO ATTEMPT TO REVIVE THE PATIENT, BUT THE ATTEMPTS WERE UNSUCCESSFUL. THE PATIENT REPORTEDLY EXPIRED IN THE OPERATING ROOM. ON 31-MAR-2022, AN INTUITIVE SURGICAL INC. (ISI) ENTERPRISE SOLUTIONS MANAGER (ESM) WAS CONTACTED AND ADDITIONAL INFORMATION WAS OBTAINED ON THIS EVENT: THE ESM WAS PRESENT FOR THE FIRST 45 MINUTES OF THIS PROCEDURE. THE PROCEDURE WAS GOING WELL WITH NO ISSUES. THE ESM LEFT THE OPERATING ROOM FOR 65 MINUTES AS THEY WENT TO CALL INTO A CONFERENCE CALL FOR ANOTHER EVENT. WHEN THE ESM RETURNED TO THE OPERATING ROOM HE NOTICED A CROWD OF PEOPLE AROUND THE OPERATING ROOM. THE ESM OBSERVED THE PATIENT UNDOCKED WITH THEIR PORT SITES BEING SUTURED AS IF THE PROCEDURE WAS COMPLETED. THE ESM ENCOUNTERED THE SURGEON LEAVING THE OPERATING ROOM AND ASKED WHAT HAPPENED. THE SURGEON SAID THE PATIENT CODED AND THAT THEY DID EVERYTHING THEY COULD BEFORE WALKING AWAY. THE ESM ASKED THE OPERATING ROOM STAFF STILL 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 DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, A THIRD PARTY STAPLER INSTRUMENT WAS USED ON UNSPECIFIED TISSUE. THE STAPLE LINE REPORTEDLY DID NOT HOLD AND CAUSED THE PATIENT TO BLEED TO DEATH. AT THIS TIME, THERE ARE NO KNOWN ALLEGATIONS AGAINST A DA VINCI PRODUCT. ON 28-JAN-2022, AN INTUITIVE SURGICAL INC. (ISI) ENTERPRISE SOLUTION MANAGER (ESM) WAS CONTACTED AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE ESM WAS MADE AWARE OF THIS EVENT FROM THE SITE ROBOTICS COORDINATOR. THE CUSTOMER SITE HAS NOT PROVIDED ANY ADDITIONAL INFORMATION AT THIS TIME AS THE EVENT IS BEING REVIEWED BY THEIR RISK MANAGEMENT DEPARTMENT. IT IS UNKNOWN WHAT BRAND THIRD PARTY STAPLER WAS USED AND ON WHAT BLOOD VESSEL. THE THIRD PARTY STAPLE LINE REPORTEDLY BLED DURING THE PROCEDURE. THE SURGEON ATTEMPTED TO CONTROL THE BLEEDING AND THEN TO RESUSCITATE THE PATIENT; BUT THE PATIENT EXPIRED. IT WAS REPORTED THAT THE VESSEL THAT WAS STAPLED AND BLED WAS VERY CALCIFIED. THE SURGEON REPORTEDLY CUT MULTIPLE CABLES AT THE PATIENT BEDSIDE TO REMOVE THEM FROM THE FIELD. IT WAS REPORTED THAT THE DA VINCI SP CAMERA CABLE WAS CUT DURING THIS EVENT. ON 15-FEB-2022, ISI C

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 30-AUG-2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN UPDATES IN SURGERY ARTICLE TITLED, ¿IMPACT OF BODY MASS INDEX ON THE EARLY EXPERIENCE OF ROBOTIC PANCREATICODUODENECTOMY¿ (CHAO, Y. J., LIAO, T. K., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: "ALL OPERATIONS WERE PERFORMED USING THE DA VINCI SI SURGICAL SYSTEM. TWO PATIENTS (2.9%) WERE CONVERTED TO OPEN SURGERY IN THE OBESE GROUP DUE TO SEVERE INFLAMMATION AT THE PANCREATIC HEAD AND TUMOR ADHESIVE TO THE SUPERIOR MESENTERIC VEIN AND NONE IN THE NORMAL-WEIGHT AND OVERWEIGHT GROUPS. THIRTY THREE PATIENTS EXPERIENCED COMPLICATIONS WITH AN OVERALL COMPLICATION RATE OF 51.5%, AND THE MAJOR COMPLICATION RATE (CLAVIEN GRADE = III) WAS 19.1%. THERE WERE 17.6% CLINICALLY RELEVANT POST-OPERATIVE PANCREATIC FISTULA (CR-POPF) (16.1% GRADE B POPF, 1.5% GRADE C POPF), 8.9% GRADE B/C POST PANCREATECTOMY HEMORRHAGE (PPH), 11.8% GRADE B/C DELAYED GASTRIC EMPTYING (DGE), AND 5.9% BILE LEAKAGE. TWELVE PATIENTS (17.6%) HAD PERIPANCREATIC FLUID COLLECTIONS, AND EIGHT OF THEM REQUIRED DRAINAGE. ONE PATIENT REQUIRED REOPERATION DUE TO FAILED EMBOLIZATION OF THE PSEU

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 BY AN UNSPECIFIED SURGEON, NOT THE CONSOLE SURGEON OF RECORD, THAT THERE WAS A REPORT OF A PATIENT DEATH OCCURRING ON AN SP DA VINCI SYSTEM. ADDITIONAL EVENT DETAILS (INCLUDING THE DATE OF THE EVENT), PATIENT DEMOGRAPHICS, PATIENT DATE OF DEATH, AND SYSTEM AND/OR PROCEDURE DETAILS WERE UNKNOWN AND UNATTAINABLE EVEN AFTER ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION. INTUITIVE SURGICAL, INC. (ISI) HAS REACHED OUT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PATIENT HAD A MILD HERNIA THAT NEEDED REPAIR. IT WAS DONE ROBOTICALLY USING THE DAVINCI SYSTEM. THE PATIENT HAD A PUNCTURED ARTERY AND A LACERATED BOWEL FROM SURGICAL ERRORS DURING THE PROCEDURE. THERE WAS EXTENSIVE INTERNAL BLEEDING. THE PATIENT BECAME SEPTIC AND WITHIN THREE DAYS WAS DEAD. THE PATIENT WAS HEALTHY WHEN HE WALKED IN EVEN THOUGH HE WAS AN OLDER PATIENT. THE PATIENT WENT TO THE HOSPITAL WITH UPPER ABDOMINAL PAIN. IT WAS DETERMINED HE HAD A HERNIA AND HE WAS SENT TO A DOCTOR TO HAVE IT REPAIRED. FDA SAFETY REPORT ID # (B)(4).

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 5-MAY-2021, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5100203 STATING: ¿A (B)(6) Y/O FEMALE WITH A HISTORY OF 12DM. HTN. UTERINE ADENO CANCER S/P HYSTERECTOMY (2016), HX OF APPENDICEAL ADENOMA SEEN ON ENDOSCOPY THAT WAS SUSPICIOUS FOR MALIGNANCY UNDERWENT A ROBOTIC ASSISTED LAP RIGHT HEMICOLECTOMY ON (B)(6) 2021. ON (B)(6) 2021 THE PATIENT BECAME HYPOXIC AND CARDIAC ARRESTED. THE PATIENT UNDERWENT THREE ROUNDS OF CPR BEFORE OBTAINING ROSC. THE PATIENT WAS TRANSPORTED TO ICU, AND THREE UNITS OF EMERGENCY RELEASED PRSCS WERE TRANSFUSED, DUE TO A PROFOUND DROP IN HER HGB, THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AND A DECISION WAS MADE TO RETURN TO THE OPERATING ROOM FOR AN EXPLORATORY LAPAROTOMY. IN THE OPERATING ROOM, THE ILEOCOLIC ARTERY WAS FOUND TO HAVE A PULSATILE BLEED AND WAS SUBSEQUENTLY LIGATED. ON RETURN TO THE ICU, PT. REMAINED HEMODYNAMICALLY UNSTABLE WITH WORSENING HYPOXIA. THE PATIENT REQUIRED INCREASED PRESSURE SUPPORT THROUGHOUT THE DAY. ON (B)(6) 2021 THE PATIENT¿S CONDITION CONTINUED TO WORSEN. ABDOMINAL COMPARTMENT SYNDROME WAS SUSPECTED AND THE DECISION WAS MADE BY THE ICU TEAM TO RE-OPEN THE ABDOMEN AT THE BEDSIDE. UPON ENTRY INTO THE ABDOMEN, 1000 CCS OF

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 BY A PROFESSOR OF RESPIRATORY SURGERY THAT A PATIENT UNDERWENT AN UNSPECIFIED UROLOGICAL DA VINCI-ASSISTED SURGICAL PROCEDURE ON AN UNSPECIFIED DATE. THE PROFESSOR INDICATED THAT THE PATIENT DIED FROM AN AIR EMBOLISM AS A RESULT OF USING AN AIR SEAL (A 3RD PARTY MANUFACTURER DEVICE) BY INCREASING THE PRESSURE TO INCREASE THE HEMOSTATIC EFFECT. ON 12-MAR-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE ISI CLINICAL SALES REPRESENTATIVE (CSR) REPORTEDLY HEARD THAT THE RESPIRATORY SURGEON HAD CONDUCTED THE DA VINCI-ASSISTED UROLOGICAL PROCEDURE. THE SURGICAL PROCEDURE WAS RECORDED ON VIDEO. HOWEVER, IT IS UNKNOWN IF THE VIDEO IS AVAILABLE FOR ISI TO REVIEW. THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS. NO FURTHER CLINICAL OR PATIENT INFORMATION WAS PROVIDED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

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 VIA SOCIAL MEDIA (I.E. (B)(6) POST) THAT A PATIENT UNDERWENT AN UNSPECIFIED DA VINCI-ASSISTED ¿BIOPSY¿ PROCEDURE AND ALLEGEDLY EXPERIENCED OPERATIVE COMPLICATIONS. PER THE INITIAL (B)(6) POSTING, THE FOLLOWING WAS NOTED: ¿MY FATHER DIED TWO YEARS AGO WHEN A DAVINCI-AIDED BIOPSY CAUSED MASSIVE BLEEDING. HE MADE ME PROMISE I WOULD NOT SUE. HE DID NOT MAKE ME PROMISE I WOULD NOT TALK ABOUT IT.¿ ON (B)(6) 2019, THE INITIAL REPORTER POSTED THE FOLLOWING SUBSEQUENT (B)(6) POSTING: ¿(B)(6). YOU CAN TAKE IT FROM THERE.¿ REFER TO THE FOLLOWING LINK FOR THE (B)(6) POSTINGS: "(B)(6)".

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 NISSEN FUNDOPLICATION PROCEDURE, A PUNCTURE WOUND WAS FOUND ON THE PATIENT'S SIGMOID COLON. THE PATIENT WAS REPORTEDLY STILL IN THE HOSPITAL. ON (B)(4) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS OBTAINED: THE CSR WAS PRESENT DURING THE DA VINCI-ASSISTED NISSEN FUNDOPLICATION PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. NO INTRA-OPERATIVE COMPLICATIONS WERE IDENTIFIED. THERE WERE ALSO NO REPORTS OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY. ON POST-OPERATIVE DAY #1, THE PATIENT HAD COMPLAINTS OF ABDOMINAL PAIN. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM (OR) AND A PUNCTURE WOUND ON THE SIGMOID COLON WAS IDENTIFIED. A BOWEL RESECTION WAS PERFORMED BY A COLORECTAL SURGEON TO ADDRESS THE BOWEL INJURY. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE CSR WAS INFORMED THAT THE PATIENT ULTIMATELY EXPIRED. THE CSR SPOKE TO THE SURGEON ABOUT THE POST-OPERATIVE COMPLICATION (I.E. BOWEL INJURY). ACCORDING TO THE CSR, THE SURGEON DID NOT K

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 — 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.

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 ¿ADHESIOLYSIS AND REDUCTION OF A SLIPPED NISSEN WITH COMPLETION LAPAROTOMY, REPAIR OF HIATAL HERNIA AND REDO OF NISSEN FUNDOPLICATION¿ PROCEDURE ON (B)(6) 2017. THE PLAINTIFFS¿ ATTORNEY ALLEGES THAT THE PATIENT ¿EXPERIENCED COMPLICATIONS DURING THE SURGERY, NAMELY ISSUES WITH THE PATIENT¿S BLOOD PRESSURE AND OXYGENATION WHEN HE INCREASED THE PRESSURE OF THE GAS INSUFFLATING THE PATIENT¿S ABDOMINAL WALL.¿ THE PLAINTIFFS¿ ATTORNEY NOTED THAT WHEN THE PRESSURE WAS DECREASED, THE SURGEON¿S ¿VISIBILITY ALSO DECREASED, LEADING HIM TO UNDOCK THE ROBOT AND CONVERT THE OPERATION TO AN OPEN SURGERY.¿ AT AN UNSPECIFIED TIME DURING THE SURGICAL PROCEDURE, THE PATIENT ALLEGEDLY SUSTAINED AN ¿ESOPHAGEAL PERFORATION RESULTING IN THE LEAKAGE OF STOMACH CONTENTS INTO HER MEDIASTINUM.¿ AS A RESULT, THE PATIENT EXPERIENCED ¿IMMEDIATE RESPIRATORY COMPLICATIONS INCLUDING ATELECTASIS, PLEURAL FLUID AND PNEUMONIA, AND EVENTUALLY TO SEPSIS.¿ THE PATIENT ALLEGEDLY EXPERIENCED ¿PAIN AND SUFFERING¿ FROM (B)(6) 2017. DURING THIS TIME, THE PATIENT REPORTEDLY HAD ¿THE INABILITY T

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-ASSISTED PROSTATECTOMY PROCEDURE, THE PATIENT EXPIRED ON AN UNSPECIFIED DATE. ACCORDING TO THE INITIAL REPORTER, THE SURGICAL PROCEDURE WAS LONG AND THERE WERE UNSPECIFIED COMPLICATIONS. THERE WERE NO REPORTED SYSTEM FAILURE ISSUES. ON 07/24/2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER, AN ISI CLINICAL SALES REPRESENTATIVE (CSR), AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS NOT PRESENT DURING THE SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. TO HER KNOWLEDGE, THE DA VINCI SURGICAL SYSTEM WAS IN THE OPERATING ROOM (OR) FOR APPROXIMATELY 13 HOURS. TO HER UNDERSTANDING, THE DA VINCI SURGICAL SYSTEM WAS USED FOR THE ENTIRE DURATION OF THE SURGICAL PROCEDURE AND THERE WERE NO REPORTS THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE CSR STATED THAT THE PATIENT REPORTEDLY HAD A TON OF ADHESIONS WHICH TOOK A WHILE TO CLEAR IN ORDER FOR THE SURGEON TO GAIN ACCESS TO THE PROSTATE. THE SURGICAL PROCEDURE WAS COMPLETED. HOWEVER, POST-OPERATIVELY THE PATIENT COMPLAINED OF SEVERE ABDOMINAL PAIN AND UNDERWENT SOME TYPE OF UNSPECIFIED SCAN. THE CSR WAS UN

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 NISSEN FUNDOPLICATION PROCEDURE, THE INSUFFLATION WAS LOST AFTER THE SURGEON SWAPPED FROM ARM 1 TO ARM 3. AT THE TIME THE EVENT OCCURRED, A HARMONIC ACE CURVED SHEARS INSTRUMENT WAS INSTALLED ON ARM 1 AND A DOUBLE FENESTRATED GRASPER INSTRUMENT WAS INSTALLED ON ARM 3. AS A RESULT OF THE LOSS OF INSUFFLATION, THE PATIENT'S DIAPHRAGM SLID DOWN AND THE HARMONIC ACE CURVED SHEARS INSTRUMENT ALLEGEDLY PUNCTURED A HOLE IN THE PATIENT'S RIGHT VENTRICLE. ONCE THE SURGEON IDENTIFIED THE OPERATIVE COMPLICATION, A CARDIO SURGEON WAS CALLED FOR IMMEDIATE OPEN HEART SURGERY. ON 06/21/2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE SITE HAS NOT DETERMINED THE CAUSE OF THE LOSS OF INSUFFLATION DURING THE SURGICAL PROCEDURE. NO ISSUES WERE IDENTIFIED WITH THE INSUFFLATION TUBING, ASSIST PORT, CANNULAS, OR CANNULA SEALS. THE SURGEON BELIEVES THE PUNCTURE WOUND TO THE PATIENT'S RIGHT VENTRICLE OCCURRED AS A RESULT OF THE LOSS OF INSUFFLATION AND MOVEMENT OF DIAPHRAGM. NO INSTRUMENTS WERE MOVED AFTER INSUFFLATION WAS LOST. AT THE TIME THE EVENT OCCURRED, THE SURGEON 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: IT WAS REPORTED, DURING AN ANONYMOUS CONSUMER SURVEY, THAT THE PATIENT'S COLON WAS ALLEGEDLY NICKED BY AN UNSPECIFIED DEVICE WHILE UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE. AS A RESULT, THE INITIAL REPORTER (THE PATIENT'S FRIEND) CLAIMED THAT THE PATIENT DEVELOPED AN UNSPECIFIED INFECTION AND WAS ADMITTED TO THE ICU FOR ABOUT 2 WEEKS BEFORE HE WAS RELEASED TO GO HOME. THE FOLLOWING NIGHT AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT WAS READMITTED TO THE HOSPITAL FOR PAIN AND SUBSEQUENTLY 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: IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY WITH HIATAL HERNIA REPAIR PROCEDURE, THE PATIENT EXPERIENCED BLOOD LOSS ON AN UNSPECIFIED DATE. IN ADDITION, APPROXIMATELY 2 WEEKS POST-OPERATIVELY, THE PATIENT WAS READMITTED TO THE OR AND HAD PART OF HER STOMACH AND BOWEL REMOVED FOR AN UNKNOWN REASON. THE INITIAL REPORTER WAS UNSURE IF THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2017. ON 06/07/2017, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: AN ISI CLINICAL SALES REPRESENTATIVE (CSR) SPOKE TO THE SITE'S OR DIRECTOR. SHE WAS UNABLE TO CONFIRM IF THE DV PROCEDURE WAS PERFORMED ON (B)(6) 2017. ACCORDING TO THE OR DIRECTOR, THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. THERE WERE ALSO NO REPORTS OF ANY MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE DA VINCI-ASSISTED SURGICAL PROCEDURE WENT SMOOTHLY AND WAS COMPLETED ROBOTICALLY. DUE TO UNSPECIFIED POST-OPERATIVE COMPLICATIONS AND POST-OPERATIVE BLEEDING FROM AN UNKNOWN SOURCE, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY. THE CSR DID NOT KNOW WHY PARTS OF THE PATIENT'S STOMACH AND BOWEL WERE REMOVED. 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 INITIALLY REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED GASTRIC BYPASS PROCEDURE, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT AND UNDERWENT AN UNSPECIFIED SURGICAL PROCEDURE. THE INITIAL REPORTER DID NOT KNOW IF THE SECONDARY OPERATION WAS RELATED TO THE DA VINCI-ASSISTED SURGICAL PROCEDURE. ON 05/09/2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE COMPLAINT: THE CSR WAS PRESENT DURING THE ENTIRE DA VINCI-ASSISTED SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. A PROCTOR WAS PRESENT DURING THE PROCEDURE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INTRA-OPERATIVE COMPLICATIONS. IN ADDITION, THERE WERE NO REPORTED ISSUES WITH THE DA VINCI SURGICAL SYSTEM DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE SURGEON INFORMED HIM THAT THE GJ AND JJ TUBES LOOKED GOOD. HOWEVER, THE SURGEON REPORTEDLY VOICED CONCERNS REGARDING THE POUCH THAT HE HAD MADE. THE CSR REITERATED THAT THERE WAS NO ALLEGATION FROM THE SURGEON OR SURGICAL STAFF THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUME

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 REPAIR PROCEDURE, PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED INTRA-OPERATIVE COMPLICATIONS. AFTER AN INITIAL ECHOGRAPHIC CONTROL WAS PERFORMED INTRA-OPERATIVELY, UNSPECIFIED LEAKAGES WERE OBSERVED. AS A RESULT, THE SURGICAL STAFF RE-OPENED AND RE-SUTURED AROUND THE VALVE. AFTER A SECOND ECHOGRAPHIC CONTROL WAS PERFORMED INTRA-OPERATIVELY, LEAKAGES WERE STILL OBSERVED. AS A RESULT, THE SURGICAL STAFF DECIDED TO CHANGE A VALVE FOR A NEW ONE. AFTER A THIRD ECHOGRAPHIC CONTROL WAS PERFORMED INTRA-OPERATIVELY, LEAKAGES WERE STILL FOUND AND THE DECISION WAS MADE TO CONVERT THE DA VINCI-ASSISTED SURGICAL PROCEDURE TO A STERNOTOMY PROCEDURE. AFTER THE SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY, THE INITIAL REPORTER LEFT THE OR ROOM. AT THIS TIME, THE ROOT CAUSES OF THE INTRA-OPERATIVE COMPLICATIONS ARE UNKNOWN. THERE WAS NO ALLEGATION DURING THE SURGICAL PROCEDURE THAT A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES HAD OCCURRED. APPROXIMATELY NINE HOURS AFTER THE CASE WAS CONVERTED TO OPEN SURGERY, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR AN UNSPECIFIED REASON. AT THIS FACILITY, THE PATI

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 INGUINAL HERNIA REPAIR PROCEDURE, THE PATIENT'S INTESTINES WERE ALLEGEDLY NICKED AND THE PATIENT PASSED AWAY WITHIN 48 HOURS FROM SEPTIC POISONING. ON (B)(6)2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS PRESENT DURING THE SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. THE DA VINCI-ASSISTED INGUINAL HERNIA REPAIR PROCEDURE WAS COMPLETED WITH NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. DURING THE SURGICAL PROCEDURE, NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY WAS REPORTED. TO HIS RECOLLECTION, THE CSR INDICATED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY THE SURGICAL PROCEDURE WAS PERFORMED. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT CAME BACK TO THE HOSPITAL FOR AN UNKNOWN REASON. THE CSR SPOKE TO THE SURGEON ABOUT THE REPORTED EVENT. ACCORDING TO THE CSR, THE SURGEON INFORMED HIM THAT THE PATIENT SUPPOSEDLY SUSTAINED A BOWEL INJURY AND THEN PASSED AWAY. THE SURGEON DID NOT INITIALLY ALLEGE THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING