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