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

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON NOTICED A FEMUR DURING PRIMARY TKA.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT PATIENT'S RIGHT MEDIAL KNEE WAS REVISED TO A PS TOTAL KNEE DUE TO PAIN AND OSTEOARTHRITIS.

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

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PATIENT HAD A MAKO UNI AND PATELLA FEMORAL REPLACEMENT ON (B)(6) 2017 AND RECENTLY PRESENTED WITH PERSISTENT PAIN. DOCTOR REMOVED IMPLANTS AND REVISED WITH A TOTAL KNEE.