CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: COMPLICATIONS WERE DESCRIBED IN A ORAL PRESENTATION (B)(6). ACCURAY PREVIOUSLY CONTACTED THE PHYSICIAN AND CONFIRMED THAT THE REPORTED COMPLICATIONS WERE NOT DUE TO A MALFUNCTION OF THE CYBERKNIFE SYS. THE PTS HAD RECEIVED PRIOR RADIOTHERAPY AND WERE UNDERGOING RE-IRRADIATION BY THE CYBERKNIFE SYS IN AN ATTEMPT TO CONTROL RECURRENT DISEASE. DUE TO THE NATURE AND EXTENT OF DISEASE, CYBERKNIFE TREATMENT WAS THE ONLY TREATMENT OPTION FOR THE PTS IN THE STUDY. THE TOXICITIES EXPERIENCED BY THE PTS ARE KNOWN TO BE ASSOCIATED WITH RE-IRRADIATION.

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 26-NOV-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE GENERAL THORACIC AND CARDIOVASCULAR SURGERY ARTICLE TITLED, ¿IS LEFT-SIDE DAVINCI PROCEDURE CHALLENGING? INITIAL EXPERIENCES OF A SINGLE INSTITUTE.¿ WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: CASE #2 INVOLVED A 66-YEAR OLD FEMALE PATIENT WITH STAGE 1A CANCER WHO UNDERWENT A DA VINCI-ASSISTED LEFT UPPER LOBECTOMY PROCEDURE ON AN UNSPECIFIED DATE. THE CAUSE OF THE CONVERSION PER TABLE 3 IN THE ARTICLE WAS AN ¿INJURY OF AORTA.¿ ¿IN CASE 2, THE AORTA WAS PARTIALLY STAPLED UPON DIVIDING THE INTERLOBAR FISSURE BETWEEN THE APICO-POSTERIOR SEGMENT OF THE LEFT UPPER LOBE AND THE APICAL SEGMENT OF THE LEFT LOWER LOBE, WHICH WAS REPAIRED BY END-TO-END ANASTOMOSIS UNDER BYPASSING WITH EXTRACORPOREAL MEMBRANOUS OXYGENATION. IN BOTH CASES CONVENTIONAL ENDOSCOPIC STAPLING DEVICES WERE EMPLOYED.¿ THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED IN RELATION TO THE REPORTED EVENT. FURTHERMORE, IT WAS NOTED IN REFERENCE TO CASE #2 (AND CASE #1), "IN BOTH CASES, CONVENTIONAL ENDOSCOPIC STAPLING DEVICES WERE EMPLOYED." ADDITIONALLY, THE ARTICLE STATES THE FOLLOWING: "WE EXPERIENCED TWO C