da Vinci Surgical System — Injury 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 SINGLE-INSTITUTION STUDY, AN EVALUATION OF PATIENTS WHO HAD UNDERGONE ROBOTIC LUNG RESECTION FOR LUNG ADENOCARCINOMA WAS PERFORMED. THE AIM OF THE STUDY WAS TO EXAMINE THE USEFULNESS OF FINAL TRANSECTION OF THE PROXIMAL PULMONARY ARTERY IN ROBOTIC LEFT UPPER LOBECTOMY AND ITS IMPACT ON PERIOPERATIVE OUTCOMES. THE STUDY TOOK PLACE BETWEEN JANUARY 2017 AND NOVEMBER 2022, DURING WHICH 49 PATIENTS UNDERWENT ROBOTIC LEFT UPPER LOBECTOMY. THE MEDIAN AGE OF THE PATIENTS WAS 69.5 YEARS IN THE BRONCHUS PRIOR TRANSECTION GROUP (BT GROUP) AND 74 YEARS IN THE ARTERY PRIOR TRANSECTION GROUP (AT GROUP). THE GROUPS DID NOT DIFFER SIGNIFICANTLY IN PREOPERATIVE FACTORS, INCLUDING AGE, SEX, SMOKING STATUS, BASELINE FUNCTION, CLINICAL TUMOR SIZE OR NODAL STATUS. TWO PATIENTS IN THE AT GROUP EXPERIENCED INTRAOPERATIVE BLEEDING. ONE PATIENT'S MOST PROXIMAL BRANCH OF THE PULMONARY ARTERY WAS INJURED WHEN THE ARTERY WAS BEING TRANSECTED WITH A STAPLER BY AN ASSISTANT SURGEON. A CONVERSION TO THORACOTOMY WAS PERFORMED, AND THE LEFT MAIN PULMONARY ARTERY WAS CLAMPED. THE INJURY WAS SUTURED USING 6-0 PROLENE. THE PATIENT LOST 2460 ML OF BLOOD AND REQUIRED A BLO

da Vinci Surgical System — Injury 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 UROLOGY SURGICAL PROCEDURE, AN ERROR OCCURRED WHEN THE ENDOSCOPE WAS CONNECTED TO THE ENDOSCOPIC CONTROLLER (EC). THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) SUGGESTED DISCONNECTING THE ENDOSCOPE CONTROLLER AND POWER CYCLE THE SYSTEM INCLUDING A HARD POWER CYCLE AND EMERGENCY POWER OFF (EPO) ON THE PATIENT SIDE CART (PSC); THIS DID NOT SOLVE THE PROBLEM. THEN, TAKING THE PICTURE OF THE EVENT LOGS AND SENDING THEM TO TECHNICAL SUPPORT AND IN PARALLEL GUIDED THE CALLER TO FIND LINE WITH ERROR 319 AND GET THE P1 VALUE WAS SUGGESTED AND TO CHECK THE SOFTWARE VERSION OF THE SYSTEM. THE PICTURE WITH THE EVENT LOGS DID NOT COME IN. THE BIOMED PERFORMED SEVERAL HARD POWER CYCLES, EPO ON THE PSC, AND POWER CABLE DISCONNECT BUT NONE SOLVED THE PROBLEM. FURTHER LOG REVIEW SHOWED ERRORS ON THE PCC 3 ON THE UCC. THE TSE INFORMED THE CUSTOMER THAT THE SYSTEM NEEDED TO BE REPAIRED. THE PROCEDURE WAS CONVERTED TO A LAPAROSCOPIC SURGERY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS INSPECTED PRIOR TO USE. THERE WERE NO ERRORS NOTED. ADDITIONAL PORTS WERE PLACED. INS

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE DESCRIBED ANALYSIS OF A RETROSPECTIVE COHORT STUDY INVESTIGATING THE IMPACT OF MARITAL STATUS ON PERIOPERATIVE OUTCOMES IN PATIENTS UNDERGOING ROBOTIC-ASSISTED PULMONARY LOBECTOMY (RAPL) FOR NON-SMALL CELL LUNG CANCER (NSCLC). THE STUDY OCCURRED FROM SEPTEMBER 2010 TO MARCH 2022, DURING WHICH 709 PATIENTS UNDERWENT RAPL. OF THE 709 SURGERIES, IT WAS REPORTED THAT THERE WERE 40 INTRAOPERATIVE COMPLICATIONS, 32 OF WHICH WERE ROBOTIC-ASSOCIATED INTRAOPERATIVE COMPLICATIONS. THE COMPLICATIONS INCLUDED PULMONARY ARTERY BLEEDING, PULMONARY VEIN BLEEDING, "OTHER" BLEEDING, TRACHEAL/BRONCHIAL INJURIES, A DIAPHRAGM INJURY, AND A PHRENIC NERVE INJURY. PERIOPERATIVE OUTCOMES INCLUDED AT TOTAL OF 39 OVERALL CONVERSIONS TO THORACOTOMY, 15 OF WHICH WERE URGENT CONVERSIONS. IN-HOSPITAL MORTALITY RATES WERE LOW IN BOTH GROUPS. THE DESIGNATED AUTHOR HAS CONFIRMED THAT THERE WERE NO DA VINCI DEVICE MALFUNCTIONS, AND THAT NO DA VINCI DEVICES CAUSED OR CONTRIBUTED TO ANY OF THE REPORTED COMPLICATIONS.

da Vinci Surgical System — Injury 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 SURGICAL PROCEDURE, SYNCHROSEAL INSTRUMENT PAINT LAYER WAS PEELED OFF. THE PROCEDURE WAS COMPLETING AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: IT WAS LATER REPORTED THAT THE DAMAGED FRAGMENT WAS FOUND IN THE BODY CAVITY BUT WAS REMOVED DIRECTLY FROM THE BODY CAVITY.

da Vinci Surgical System — Injury 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 SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE INTEGRATED ELECTROSURGICAL UNIT (IESU) DISPLAYED AN ERROR MESSAGE AND COULD NOT BE USED. THE ISI TSE CHECKED LOGS AND NOTED ERRORS M-12. THE ISI TSE ASKED THE CUSTOMER TO CHECK THE EXTREMAL FOOT PEDALS IN A DRAWER AND ENSURE THEY WERE NOT PUSHED OR STUCK; THE CUSTOMER INFORMED THEY HAD ALREADY DONE SO AND VERIFIED NOTHING PUSHING ON THE PEDALS. THE ISI TSE GUIDED THE CUSTOMER TO DISCONNECT THE EXTERNAL FOOT PEDALS FROM ERBE'S REAR PANEL AND THE ERROR CLEARED. THE ISI TSE INFORMED THE CUSTOMER THAT THE ISI FSE WOULD VISIT TO RESOLVE THE ISSUE PERMANENTLY. THE CUSTOMER CALLED BACK AND REPORTED ERROR HAD RETURNED; THE ERROR MESSAGE RETURNED WHEN THE BIPOLAR EXTERNAL PEDAL WAS PLUGGED IN AND WHEN THE MONOPOLAR WAS DISCONNECTED, THE SURGEON COULD NOT CONTROL ERBE FROM THE SURGEON SIDE CONSOLE (SSC). THE ISI TSE SUGGESTED VERIFYING THE CORRECT CONNECTORS WERE DISCONNECTED, THE CUSTOMER DID SO. THE CUSTOMER NEEDED IESU FOR THE PROCEDURE, SO THE PROCEDURE WAS MOST LIKELY TO BE CONVERTED. THE ISI

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

da Vinci Surgical System — Injury 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 TRANSANAL TOTAL MESORECTA EXCISION SURGICAL PROCEDURE, THE HARMONIC ACE TIP BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. IT WAS CONFIRMED THAT THE FRACTURED PART WAS COMPLETELY REMOVED, AND NO FRAGMENT REMAINED INSIDE THE PATIENT. THE SURGEON STATED THAT THERE WAS NO INSTRUMENT COLLISION. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER USED A LAPAROSCOPIC INSTRUMENT TO RETRIEVE THE FRAGMENT. ALL FRAGMENTS WERE RETRIEVED; NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE ANY FRAGMENTS. THERE WERE NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE SURGEON WAS NOT AWARE OF WHAT CAUSED THE INSTRUMENT TO BREAK. THE INSTRUMENT WAS IN USE FOR ABOUT 15 MINUTES WHEN THE ISSUE WAS IDENTIFIED. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE ISSUE WAS IDENTIFIED DURING THE DISSECTION; THERE WERE NO ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT NOTED PRIOR TO THE REPORTED ISSUE. THE FRAGMENT DID NOT FALL INSIDE THE PATIENT DURING INSTRUMENT TIP INSPECTION.

da Vinci Surgical System — Injury 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 SURGICAL PROCEDURE, THE HARMONIC ACE BLADE BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. IT WAS CONFIRMED THAT THE FRACTURED PART WAS COMPLETELY REMOVED, AND NO FRAGMENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED.

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 — Injury 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 MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, A BLACK VALVE WAS BROKEN ON THE THIRD PORT CANNULA AND FELL INTO THE PATIENT. THE VALVE WAS THOUGHT TO BE FROM THE UNIVERSAL SEAL, BUT THE CUSTOMER CONTINUED TO USE THE PRODUCT WITHOUT REPLACEMENT. THE OPERATION WAS TERMINATED. THERE WAS NO BLEEDING DUE TO THE ISSUE NOR ANY TISSUE/VASCULAR DAMAGE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CLARIFIED THAT THE FRAGMENTS WERE RETRIEVED WITH A LAPAROSCOPIC INSTRUMENT, AND THEY CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED USING THE ENDOSCOPE. THERE WAS NO ADDITIONAL PROCEDURE REQUIRED, THERE WAS A POST-OPERATIVE TEST DONE. THE CUSTOMER COMPLETED THE PROCEDURE ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL FOR ANY COMPLICATIONS. THE ACCESSORY IS NOT AVAILABLE FOR RETURN AND THE FRAGMENT WAS DISCARDED.

da Vinci Surgical System — Injury 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 WITH LYMPHADENECTOMY PROCEDURE, THE PATIENT HAD A POST-OPERATIVE PULMONARY EMBOLISM; THE SURGEON OF THE PROCEDURE REPORTED THAT THE PATIENT ALMOST DIED. THE PROCEDURE WAS FOUR HOURS LONG AND WAS COMPLETED WITHOUT COMPLICATIONS. THE SURGEON SAID THE EMBOLISM WAS NOT RELATED TO THE USE OF THE DA VINCI SINGLE PORT (SP) SYSTEM. THE SURGEON WAS BEING PROCTORED THIS PROCEDURE. THE SURGEON REPORTED THAT THE PATIENT RECEIVED NORMAL THROMBOSIS PROPHYLAXIS WITH TIGHT SOCKS AND LOW MOLECULAR HEPARIN POSTOPERATIVELY FROM OR-DAY AND ONWARDS (HOSPITAL STANDARD). THE PATIENT EXPERIENCED A THROMBOEMBOLIC PULMONAL EMBOLISM CENTRALLY WITH PAIN AND DIFFICULTIES TO BREATH WITHOUT A FULMINANT EVENT TWO DAYS AFTER SURGERY. THE PATIENT EXPERIENCED DIFFICULTIES TO RECOVER APPROPRIATELY AFTER SURGERY AND DID NOT FEEL WELL. THE EMBOLISM WAS CONFIRMED WITH A CT-SCAN OF THE THORAX AND ELEVATED D-DIMER SCORES. THE PATIENT RECEIVED CONSERVATIVE TREATMENT WITH HEPARIN ON A THERAPEUTIC LEVEL. THE PATIENT DEVELOPED A RETRO-VESICAL HEMATOMA AND INSUFFICIENCY OF THE ANASTOMOSIS WITH SEVERAL TRANSFUSIONS. THE PATIENT WAS PLACED IN THE INTENSIVE CARE

da Vinci Surgical System — Injury 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 — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DESCRIPTION OF EVENT ON (B)(6) 2024, THE PATIENT UNDERWENT A ROBOTIC-ASSISTED PARTIAL HYSTERECTOMY UTILIZING THE DA VINCI ROBOTIC SURGICAL SYSTEM AT (B)(6) MEDICAL CENTER IN (B)(6). FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED SEVERE AND LIFE-THREATENING POSTOPERATIVE COMPLICATIONS, INCLUDING: SEPSIS, MULTIPLE ORGAN DAMAGE, SEVERE INFECTION LEADING CHRONIC LONG-TERM INFECTIONS, PROLONGED HOSPITALIZATION, ADDITIONAL SURGEONS, COVERING 4 MAJOR BODY SYSTEMS, PERMANENT PHYSICAL IMPAIRMENT AND SEVERE EMOTIONAL MEDICAL ANXIETY. THE SEVERITY AND PROGRESSION OF THESE COMPLICATIONS RAISES SIGNIFICANT CONCERNS REGARDING POTENTIAL DEVICE-RELATED INJURY, DELAYED RECOGNITION OF INTRAOPERATIVE INJURY, OR POSSIBLE MALFUNCTION OR LIMITATIONS ASSOCIATED WITH THE ROBOTIC SURGICAL SYSTEM. DEVICE-RELATED CONCERNS BASED ON MEDICAL RECORDS AND POSTOPERATIVE CLINICAL COURSE, THE FOLLOWING CONCERNS REQUIRE INVESTIGATION: 1. POSSIBLE DEVICE MALFUNCTION THERE IS CONCERN THAT THE DA VINCI ROBOTIC SURGICAL SYSTEM MAY HAVE EXPERIENCED MALFUNCTION, CALIBRATION ERROR, OR MECHANICAL OR SOFTWARE-RELATED PERFORMANCE ISSUES DURING THE PROCEDURE. 2. INADEQUATE VISUALIZATION THERE IS CONCERN THAT VISUALIZATION PRO

da Vinci Surgical System — Injury 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 SURGICAL PROCEDURE, THE CUSTOMER REPORTED THEY HAD ISSUES WITH THE UNIVERSAL SEAL. THE CUSTOMER REPORTED ONE OF THE UNIVERSAL SEALS CAME APART AND A PIECE OF THE RUBBER FELL OFF INTO THE ABDOMEN OF THE PATIENT. THE PIECE WAS RECOVERED DURING THE SAME PROCEDURE. ADDITIONALLY, DURING THE SAME PROCEDURE, ONE OF THE OTHER UNIVERSAL SEALS HAD THE PLASTIC INSUFFLATION PORT BREAK OFF. THERE WAS NO MENTION OF ANY FRAGMENT FALLING INSIDE THE PATIENT WITH THE SECOND UNIVERSAL SEAL. THE CUSTOMER WAS NOT ABLE TO RECORD THE LOT NUMBER OF THE SEALS USED BUT THEY WILL BE SENDING THE DAMAGED ONES BACK FOR INVESTIGATION. BOTH SEALS WERE REMOVED AND REPLACED AND THEY WERE ABLE TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON WAS ABLE TO REMOVE ALL FRAGMENTS PER THE STAFF REPORT. THE REPORTER STATED THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. THERE WAS NO POST-OPERATIVE TEST LIKE AN X-RAY OR ULTRASOUND TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING REVIEW OF A LITERATURE ARTICLE THAT ADDRESSES THE POSSIBLE BENEFITS OF NERVE MONITORING DURING DA VINCI-ASSISTED RADICAL PROSTATECTOMY SURGICAL PROCEDURES, THE FOLLOWING COMPLICATIONS WERE MENTIONED: THE STUDY WITH 100 PATIENTS ENROLLED, EXAMINED THE BENEFITS OF USING A NERVE MONITORING SYSTEM DURING ROBOT-ASSISTED RADICAL PROSTATECTOMY (THE INTERVENTION ARM) VERSUS THE STANDARD OF CARE (THE CONTROL GROUP). AVAILABLE FOR FINAL ANALYSIS AT 12 MONTHS 82 PATIENTS REMAINED IN THE STUDY, 41 PATIENTS IN EACH GROUP. THERE WERE EIGHT CLAVIEN-DINDO GRADE GREATER THAN OR EQUAL TO III COMPLICATIONS, ONE CASE OF SEVERE MESENTERIC BLEEDING, ONE RECTAL LESION, AND ONE SPHINCTERIC LESION, ALL IN THE CONTROL GROUP. THERE WERE FIVE CASES OF ANASTOMOSIS LEAKAGE, TWO IN THE INTERVENTION GROUP AND THREE IN THE CONTROL GROUP. WE DETECTED NERVE SIGNALS DURING MONITORING IN ALL PARTICIPANTS IN THE INTERVENTION GROUP BEFORE THE REMOVAL OF THE PROSTATE. THERE WERE NO STATISTICALLY SIGNIFICANT DIFFERENCES IN SURGICAL TIME OR BLOOD LOSS. THERE WAS NO REPORT IN THE ARTICLE THAT A DA VINCI DEVICE MALFUNCTIONED DURING THE PROCEDURES. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL

da Vinci Surgical System — Injury 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 SURGICAL PROCEDURE, THE SYNCHROSEAL ¿SCREW¿ CAME OFF. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUE. THE SCREW FELL INTO THE PATIENT¿S ANATOMY WHEN THE INSTRUMENT WAS BEING USED. THE INSTRUMENT DID NOT GRASP THE TISSUE. THE SURGEON BELIEVED THAT MANUFACTURING WAS THE CAUSE OF THE ISSUE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR HARD MATERIAL. THE SURGEON USED A LAPAROSCOPIC FORCEPS TO RETRIEVE THE FRAGMENT. NO ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE FRAGMENT. UPON VISUAL INSPECTION, THE SURGEON CONFIRMED THAT THERE WAS NO REMAINING FRAGMENT. NO POST-OPERATIVE TESTS WERE PERFORMED. THE SURGEON STATED THAT NO PATIENT INJURY. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE INSTRUMENT AND THE FRAGMENT WILL BE RETURNED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TA LITERATURE ARTICLE WAS REVIEWED 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 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. THE STUDY REPORTED 64 INTRAOPERATIVE COMPLICATIONS, WITH BOWEL INJURIES BEING THE MOST COMMON. TWO PATIENTS EXPERIENCED TROCAR LESIONS OF THE COLON REQUIRING CONVERSION TO LAPAROTOMY, WHILE THE OTHER BOWEL LESIONS (TYPICALLY SEROSAL TEARS OR THERMAL LESIONS) WERE HANDLED BY ROBOT-ASSISTED SUTURING. VASCULAR COMPLICATIONS OCCURRED IN 16 PATIENTS, INCLUDING ONE BLUNT LESION OF THE ABDOMINAL AORTA DURING ENTRY WITH A BLUNT-TIP TROCAR IN A VERY SLIM PATIENT, AND 1 LESION OF THE RIGHT EXTERNAL ILIAC VEIN FOLLOWING LYMPHADENECTOMY AFTER PELVIC IRRADIATION. BOTH 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: 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 — Injury 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 HYSTERECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT STOPPED WORKING. A PIECE OF THE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE INSTRUMENT FRAGMENT WAS RETRIEVED DURIGN THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT WHO WAS ENROLLED IN A CLINICAL STUDY UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY. A 6MM SKIN BURN WAS FOUND ON THE RIGHT BREAST WITH A SMALL BLISTER, DURING INTERNAL DISSECTION. THE BURN WAS TREATED WITH TOPICAL (BACITRACIN) TWICE DAILY. THERE WAS NO DEVICE MALFUNCTION OCCURRED THAT COULD HAVE CONTRIBUTED TO THE BURN AND THE SURGEON THOUGHT THE BURN WAS CAUSED BY DISSECTION TOO CLOSE TO THE DERMIS DURING INTERNAL DISSECTION.

da Vinci Surgical System — Injury 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 — Injury 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 BENIGN HYSTERECTOMY, THE ENTIRE TIP FROM THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT THE ENTIRE PIECE WAS RETRIEVED AND ACCOUNTED FOR DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

da Vinci Surgical System — Injury 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 SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIPS COVER ACCESSORIES FELL OFF THE INSTRUMENTS INSIDE THE PATIENT. THE SURGEON RETRIEVED THE MCS TIP COVER ACCESSORIES AND USED A MONOPOLAR CAUTERY INSTRUMENT WITH A HOOK TIP TO COMPLETE THE PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE AND NO DAMAGE WAS OBSERVED. THE MCS TIP COVER WAS RETRIEVED WITH A GRASPER. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE SURGICAL PROCEDURE. THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE AND NO PART OF THE ORANGE SURFACE WAS VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED. THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. THE INSTALLATION TOOL WAS USED. THERE WAS NO DIFFICULTY IN REMOVING THE INSTRUMENT AND MCS TIP COVER ACCESSORY. THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. THE PROCEDURE WAS ROBOTICALLY COMPLETED. THE MCS TIP COVER ACCESSORY AND INSTRUMENT WERE NOT AVAILA

da Vinci Surgical System — Injury 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 RIGHT PARTIAL NEPHRECTOMY PROCEDURE, THE PATIENT HAD A LOT OF BLEEDING. THE PROCEDURE WAS ABORTED AND CONVERTED TO OPEN SURGERY. DURING THE PROCEDURE, A THIRD-PARTY GOLD SCANLAN BULLDOG CLAMP WAS USED VIA A SEPARATE PORT SITE. THE USE OF THE SCANLAN BULLDOG CLAMP WAS A REQUIRED STEP FOR THE PROCEDURE, THIS WAS USED TO CLAMP THE RENAL ARTERY. THE SURGEON REPORTED THAT THE SCANLAN BULLDOG CLAMP DID NOT HAVE A STRONG ENOUGH GRIP TO CLAMP THE PATIENT'S STIFF RENAL ARTERY WHICH CAUSED A LOT OF BLEEDING. THE BLEEDING COULD NOT BE CONTROLLED, AND THE PROCEDURE WAS CONVERTED TO OPEN. THE PATIENT WAS REPORTED TO BE STABLE AND REMAINS HOSPITALIZED. THE SURGEON REPORTED THAT THERE WAS NOT AN ISSUE WITH THE SINGLE PORT PLATFORM BUT RATHER, WITH THE THIRD-PARTY INSTRUMENTATION CLAMPING PRESSURE.

da Vinci Surgical System — Injury 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 BENIGN HYSTERECTOMY, THE ENTIRE TIP FROM THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT THE ENTIRE PIECE WAS RETRIEVED AND ACCOUNTED FOR DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW WAS CONDUCTED OF A LITERATURE ARTICLE COMPARING DA VINCI-ASSISTED ROBOTIC PARTIAL PANCREATODUODENECTOMY (RPD) WITH OPEN PARTIAL PANCREATODUODENECTOMY (OPD) SURGICAL PROCEDURES AT A HIGH-VOLUME PANCREATIC CENTER, HIGHLIGHTED FINDINGS OF A RANDOMISED CONTROLLED TRIAL (RCT) WITH TWO PARALLEL STUDY ARMS. THE STUDY INCLUDED 81 PATIENTS (41 ROBOTIC AND 40 OPEN) OVER A PERIOD OF APPROXIMATELY 1 1/2 YEARS AND COMPARED THE OUTCOMES OF THE RPD PATIENTS VERSUS THOSE OF THE OPD PATIENTS. DESCRIBED OUTCOMES INCLUDED POST-PANCREATECTOMY HEMORRHAGES (4 VERSUS 1), MAJOR BILIARY LEAKS (5 VERSUS 3), DELAYED GASTRIC EMPTYING (10 VERSUS 2), AND MAJOR CHYLE LEAKS (2 VERSUS 1). ALSO, IN THE RPD GROUP, 4 PATIENTS REQUIRED RE-OPERATION, 5 PATIENTS REQUIRED READMISSION, 15 PATIENTS REQUIRED NON-SURGICAL REINTERVENTION, 20 PATIENTS REQUIRED CT-GUIDED DRAIN PLACEMENT, 4 PATIENTS REQUIRED ANGIOGRAPHY, AND 7 PATIENTS REQUIRED UNSPECIFIED REINTERVENTION. BLOOD LOSS AND THE NUMBER OF PATIENTS WITH INTRAOPERATIVE BLOOD TRANSFUSIONS DID NOT DIFFER RELEVANTLY BETWEEN BOTH GROUPS. THE STUDY INDICATED THAT IN THE SETTING OF A VERY HIGH-VOLUME CENTER, BOTH RPD AND OPD CAN BE CONSIDERED SAFE TECHNIQUES. THERE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, AFTER THE PATIENT WAS UNDER ANESTHESIA, A NON-RECOVERABLE FAULT 319 OCCURRED ON THE PATIENT SIDE MANIPULATOR (PSM) 1. THE CUSTOMER PERFORMED HARD POWER CYCLE OF THE SYSTEM, BUT THE SAME ISSUE PERSISTED. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON, AND THE SYSTEM INITIALIZED WITHOUT ERROR. THE CUSTOMER IDENTIFIED THE ISSUE AFTER PORTS PLACEMENT. THERE WERE NO INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS IDENTIFIED. IT WAS UNKNOWN IF THE CONVERSION RESULTED IN INCREASING PORT SIZE INCISION OR ADDING ADDITIONAL PORTS.

da Vinci Surgical System — Injury 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 GASTRIC BYPASS (ROUX-EN-Y) SURGICAL PROCEDURE, THE CUSTOMER REPORTED AN ISSUE WITH THE VESSEL SEALER EXTEND (VSE). THE VSE FAILED AND RESULTED IN AN ABORT TO OPEN. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS BUT FOUND NO RELATED ISSUE. THE CUSTOMER HAD NO ADDITIONAL DETAILS ABOUT THE ISSUE AS FAR AS THE ARM IT WAS INSTALLED IN, WHETHER THE VSE WAS USED IN THE E100/IESU, OR HOW EXACTLY THE VSE FAILED BUT THE CUSTOMER HAS INDICATED SOMETHING WAS WRONG AND WAS NOT GOING TO PERFORM SURGERY WITHOUT THE SYSTEM BEING CHECKED. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW WAS CONDUCTED OF A CLINICAL ARTICLE THAT ASSESSED THE EFFECTIVENESS AND FEASIBILITY OF ROBOTIC PORTAL RESECTION (RPR) FOR MEDIASTINAL TUMORS AND THE FOLLOWING COMPLICATIONS WERE NOTED: (B)(4) PATIENTS WITH MEDIASTINAL TUMORS BETWEEN (B)(6) 2018 AND (B)(6) 2023 WERE ENROLLED IN THE STUDY. MOST PATIENTS WERE ASYMPTOMATIC ((B)(4)), AND NO MYASTHENIA GRAVIS WAS IDENTIFIED IN THE ENTIRE COHORT. ONE PATIENT EXPERIENCED AN INTRA-OPERATIVE LEFT INNOMINATE VEIN INJURY. THE INJURY WAS SUTURED USING A ROBOTIC PROCEDURE AND WITHOUT THE NEED FOR A CONVERSION TO THORACOTOMY. ALTHOUGH THE BLOOD LOSS DUE TO THE INJURY WAS NOT PROVIDED, IT WAS MENTIONED THAT THE MEDIAN BLOOD LOSS WAS 20 ML WITH THE RANGE OF 5.0¿30.0 ML FOR THE ENTIRE COHORT. (B)(4) PATIENTS UNDERWENT ACTIVE CONVERSION TO STERNOTOMY BECAUSE THE TUMORS WERE FOUND TO INVOLVE THE LEFT INNOMINATE VEIN DURING SURGERY. POSTOPERATIVE COMPLICATIONS WERE DEVELOPED IN (B)(4) PATIENTS, INCLUDING (B)(4) PATIENT WITH CHYLOTHORAX. THE POSTOPERATIVE CHYLOTHORAX WAS TREATED WITH CONSERVATIVE THERAPY (I.E. FASTING AND TOTAL PARENTERAL NUTRITION (TPN)) TO SUPPORT THE PATIENT. THE CHYLOTHORAX WAS RESOLVED AFTER 4 DAYS OF CARE. NO PERIOPERATIV

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW WAS CONDUCTED OF A CLINICAL ARTICLE THAT ASSESSED THE SAFETY AND FEASIBILITY OF MINIMALLY INVASIVE CYTOREDUCTIVE PROSTATECTOMIES (CRP) OF SINGLE-PORT (SP) OR MULTI-PORT (MP) ROBOTIC SYSTEMS, AND THE FOLLOWING COMPLICATIONS WERE MENTIONED. TWENTY-FOUR PATIENTS THAT UNDERWENT ROBOTIC-ASSISTED CRP IN ONE SINGLE INSTITUTION BETWEEN 2015 TO 2022 WERE ENROLLED IN THE STUDY. OF THE 24 MEN WITH A MEDIAN PROSTATE SPECIFIC ANTIGEN (PSA) OF 32 NG/ML WHO UNDERWENT CRP, 17 (71%) WERE DONE USING THE MP ROBOTIC SYSTEMS AND 7 (29%) WERE USING THE SP SYSTEMS. THE OVERALL MAJOR COMPLICATION RATE WAS 8%. IN THE MULTI-PORT GROUP, ONE PATIENT DEVELOPED A SMALL BOWEL OBSTRUCTION REQUIRING SURGICAL DECOMPRESSION (GRADE III), AND ANOTHER EXPERIENCED A LYMPHOCELE THAT REQUIRED PERCUTANEOUS INTERVENTION (GRADE III). TWO PATIENTS IN THE MULTI-PORT GROUP WERE REPORTED AS EXPERIENCING AN ANASTOMOTIC LEAK, BUT NO MEDICAL INTERVENTION NOR THE SEVERITY WERE PROVIDED IN THE ARTICLE. THERE WAS NO MENTION OF ANY DEVICE MALFUNCTIONS REPORTED DURING THE ROBOTIC ASSISTED SURGERIES IN THE ARTICLE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE AUTHORS, BUT NO RESPONSE HAS BEEN RECEIVED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOTIC MEGA SUTURE CUT NEEDLE DRIVER'S WIRES BROKE WHILE INSIDE PATIENT. SURGEON AWARE. NO VISIBLE SIGNS OF ANY PIECES LEFT INSIDE PATIENT. INSTRUMENT REMOVED FROM SERVICE AND GIVEN TO RISK MANAGER.

da Vinci Surgical System — Injury 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 — Injury 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 — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF A LITERATURE ARTICLE DESCRIBING A RETROSPECTIVE ANALYSIS OF ALL PATIENTS UNDERGOING DA VINCI-ASSISTED ROBOTIC DISTAL PANCREATECTOMY (DP) AND PANCREATICODUODENECTOMY (PD) PROCEDURES PERFORMED BY A SINGLE SURGEON, WAS COMPLETED. THE STUDY EVALUATED THE SAFETY AND FEASIBILITY OF INSTITUTING A ROBOTIC PANCREATECTOMY PROGRAM. THE STUDY INCLUDED SURGERIES FROM MAY 2014 TO DECEMBER 2020, DURING WHICH 62 PATIENTS UNDERWENT ROBOTIC PANCREATECTOMY, 34 PATIENTS WERE IN THE PD GROUP AND 28 PATIENTS WERE IN DP GROUP. 13 PATIENTS REQUIRED CONVERSION TO OPEN SURGERY IN PD GROUP DUE TO VEIN RESECTION, BILIOPANCREATIC RESECTION OR DIFFICULT DISSECTION. POST-OPERATIVELY, IN THE PANCREATICODUODENECTOMY (PD) GROUP, NINE PATIENTS (26.5%) EXPERIENCED CLAVIEN-DINDO GRADE III OR MORE COMPLICATIONS COMPARED TO 5 PATIENTS (17.9%) IN THE DISTAL PANCREATECTOMY (DP) GROUP. OF THE 5 GRADE B/C POSTOPERATIVE PANCREATIC FISTULA (POPF) IN THE PD GROUP, 4 PATIENTS REQUIRED OPERATIVE INTERVENTION WHILST ALL OF THOSE IN THE DP GROUP WERE MANAGED EITHER ENDOSCOPICALLY OR WITH PROLONGED USE OF SURGICAL DRAINS. THREE PATIENTS EXPERIENCED POST-PANCREATECTOMY HEMORRHAGE IN PD GROUP WHILE 1 PATIENT IN DP GROUP.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A STUDY TO EVALUATE THE ONCOLOGICAL OUTCOMES POST TRANSORAL ROBOTIC SURGERY (TORS) FOR HUMAN PAPILLOMAVIRUS (HPV)-ASSOCIATED OROPHARYNGEAL SQUAMOUS CELL CARCINOMA, WAS SUMMARIZED IN A LITERATURE ARTICLE DESCRIBING A RETROSPECTIVE ANALYSIS ON 184 PATIENTS THAT UNDERWENT DA VINCI-ASSISTED TRANSORAL ROBOTIC SURGERY (TORS) WITH NECK DISSECTION IN ONE SINGLE INSTITUTION PERFORMED BY TWO TRAINED SURGEONS. POST-OPERATIVE TORS-RELATED COMPLICATIONS OCCURRED IN 12 PATIENTS (6.5%). NINE PATIENTS (4.9%) HAD A SECONDARY POST-OPERATIVE BLEED, DEFINED AS BLEEDING OCCURRING GREATER THAN 24 HOURS FOLLOWING SURGERY, WITH ALL PATIENTS BEING SUCCESSFULLY MANAGED EITHER CONSERVATIVELY OR WITH OPERATIVE MANAGEMENT. SALIVARY FISTULA OCCURRED IN 2 PATIENTS (1.1%). PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) INSERTION FOR SWALLOWING DYSFUNCTION OCCURRED IN 10 PATIENTS (5.4%) WITH ONLY 2 PATIENTS (1.1%) REQUIRING FOR GREATER THAN 12 MONTHS. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. ATTEMPTS WERE MADE TO CONTACT THE ARTICLE 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: 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 — Injury 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 — Injury 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 SURGICAL PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT FRACTURED AS THE INSTRUMENT WAS ACTIVATED. THE SURGEON CLAIMED THAT HE DID NOT TOUCH ANY HARD OBJECTS WITH THE INSTRUMENT. THE FRACTURED PIECE FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED.

da Vinci Surgical System — Injury 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 PLANNED DA VINCI-ASSISTED SP (SINGLE-PORT) PROSTATECTOMY PROCEDURE, AN ARM WAS NOT ACCEPTING STERILE ADAPTERS. THE STERILE ADAPTERS KEPT POPPING OFF ARM #3. AS A RESULT, THE CUSTOMER ELECTED TO CONVERT THE SURGICAL PROCEDURE TO A MULTI-PORT DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE.

da Vinci Surgical System — Injury 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 SURGICAL PROCEDURE, THE CUSTOMER HAD UNSPECIFIED PROBLEMS WITH A HARMONIC ACE INSTRUMENT. A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT AND IT WAS UNKNOWN IF IT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

da Vinci Surgical System — Injury 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: 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 — Injury 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 LOW ANTERIOR RESECTION (LAR) AND WAS ENROLLED IN A CLINICAL STUDY. THE PROCEDURE WAS COMPLETED WITH NO INTRA-OPERATIVE COMPLICATIONS. NO DEVICE MALFUNCTIONS WERE REPORTED. THE PATIENT WAS FOUND WITH AN INCISION SITE INFECTION EIGHT DAYS POST-OPERATIVELY AND DRAINAGE WAS PERFORMED. THERE WAS NO MENTION OF OTHER MEDICAL INTERVENTION OR MEDICATION GIVEN FOR THE INFECTION. THE PATIENT WAS DISCHARGED HOME THREE WEEKS AFTER THE PROCEDURE, BUT UNKNOWN IF THE INFECTION PROLONGED THE HOSPITALIZATION.

da Vinci Surgical System — Injury 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 SINGLE-PORT (SP) SURGICAL PROCEDURE, THE SYSTEM DISPLAYED A MESSAGE INDICATING THAT THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) WAS NOT CONNECTED AND HAD A DIRTY FIBER CABLE MESSAGE. THE CUSTOMER CHECKED THE CABLE CONNECTIONS TO THE IESU, SURGEON SIDE CONSOLES (SSC) AND THE PATIENT SIDE CART (PSC) PRIOR TO CALLING IN THE ISSUE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND NOTED A 307 ERROR POINTING TO THE VIDEO PROCESSOR (VP). THE TSE HAD THE CUSTOMER POWER OFF THE SYSTEM AND ENSURE THAT THE FIBER CABLES WERE FULLY SEATED ON THE BACK OF THE CORE AND VP, RESEAT THE ORANGE FIBER CABLES, AND ENSURE THAT THE BREAKERS OF THE VP AND ENDOSCOPE CONTROLLER (EC) WERE ON. THE SYSTEM POWERED ON WITH NO OTHER ERRORS, BUT LATER THE ERRORS RETURNED. THE TSE HAD THE CUSTOMER POWER CYCLE THE COMPONENTS AGAIN AND RESEAT THE FIBER CABLES. THE VP FAULTED AGAIN AND INDICATED A RED FIBER CABLE STATUS ON THE CORE TO THE VP. THE CUSTOMER USED A FIBER CABLE FROM THE SIMULATOR AND THE ERRORS CLEARED AGAIN. THE CUSTOMER THEN CALLED LATER AND REPORTED THAT THE VP FAULT RETURNED AS A N

da Vinci Surgical System — Injury 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 — Injury 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 UNILATERAL INGUINAL HERNIA REPAIR SURGICAL PROCEDURE, THE SURGEON FELT A SHOCK PULSING SENSATION IN HIS FOOT WHEN PRESSING THE FOOT PEDAL. THE SURGEON REPORTED WHEN HE PRESSED THE COAGULATION PEDAL, AN IMMEDIATE INTENSE PULSATING SHOCK SENSATION FROM HIS RIGHT GREAT TOE TO HIS HIP, WHEN RELEASING THE PEDAL, IT WOULD STOP WITH NO LINGERING SENSATION AT ALL, OCCURRING APPROXIMATELY 4-5 TIMES DURING THE PROCEDURE. (CLOG SLIP-ON SHOES WERE WORN). THE PROCEDURE WAS CONTINUED WITH THE FENESTRATED BIPOLAR FORCEPS AND NOT THE COAGULATION BUTTON FOR THE REMAINDER OF THE PROCEDURE. THERE IS NO INJURY FROM THIS EVENT AND THE PROCEDURE WAS COMPLETED AS PLANNED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF A CLINICAL ARTICLE WAS CONDUCTED BASED ON A RETROSPECTIVE STUDY EVALUATING THE SAFETY AND FEASIBILITY OF MINIMALLY INVASIVE GASTRECTOMY IN PATIENTS WITH ADVANCED GASTRIC CANCER WHO HAD UNDERGONE PREOPERATIVE CHEMOTHERAPY. THE STUDY, WHICH ANALYZED 150 CASES FROM JANUARY 2009 TO MARCH 2022, FOCUSED ON BOTH DA VINCI ROBOTIC AND LAPAROSCOPIC GASTRECTOMY APPROACHES. THE RESULTS DEMONSTRATED THAT MINIMALLY INVASIVE PROCEDURES, PARTICULARLY ROBOTIC GASTRECTOMY, WERE FEASIBLE AND SAFE, WITH MINIMAL BLOOD LOSS (72 GRAMS) AND MANAGEABLE COMPLICATIONS. NOTABLY, CONVERSION SURGERY WAS PERFORMED IN 41 CASES (27.3%), AND PANCREATIC FISTULA WAS THE MOST COMMON COMPLICATION, OCCURRING IN 11 PATIENTS. POSTOPERATIVE COMPLICATIONS (GRADE > OR = 3A) WERE OBSERVED IN 18 PATIENTS. THE STUDY ACKNOWLEDGED LIMITATIONS, INCLUDING ITS RETROSPECTIVE DESIGN, SMALL SAMPLE SIZE, AND SHORT FOLLOW-UP PERIOD. OVERALL, ROBOTIC GASTRECTOMY SHOWED POTENTIAL FOR IMPROVED SURGICAL SAFETY, ESPECIALLY IN COMPLEX CASES INVOLVING SPLENECTOMY, AND FURTHER INVESTIGATION IS NEEDED TO REFINE TREATMENT STRATEGIES AND ASSESS LONG-TERM OUTCOMES. THE RESEARCHERS DID NOT REPORT ANY SPECIFIC MALFUNCTIONS OR INJURIES RELA

da Vinci Surgical System — Injury 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 — Injury 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 HYSTERECTOMY PROCEDURE, A PLASTIC PART OF THE SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE FRAGMENT DURING THE SAME PROCEDURE. THE CUSTOMER USED AN UNSPECIFIED BACKUP INSTRUMENT TO CONTINUE COMPLETING THE PROCEDURE AS PLANNED.

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) HAS REVIEWED AN ARTICLE THAT COMPARED THE FEASIBILITY AND SAFETY OF THE REVO-I ROBOT SYSTEM TO DA VINCI SURGICAL SYSTEMS FOR ROBOT-ASSISTED PANCREATICODUODENECTOMIES (RPD) AND THE FOLLOWING COMPLICATIONS WERE MENTIONED: A TOTAL OF 10 PATIENTS UNDERWENT REVO-I ROBOT ASSISTED RPD AND A TOTAL OF 37 PATIENTS UNDERWENT DA VINCI ASSISTED RPD BETWEEN MARCH 2017 AND AUGUST 2020. THERE WAS NO STATISTICAL DIFFERENCE IN THE INTRAOPERATIVE BLOOD LOSS BETWEEN THE TWO GROUPS, BUT THERE WAS ONE CASE OF INTRA-OPERATIVE TRANSFUSION REQUIRED IN THE DA VINCI GROUP. THE DA VINCI GROUP HAD TWO CASES OF CLAVIEN-DINDO GRADE IIIB COMPLICATIONS THAT REQUIRED REOPERATION. ONE PATIENT WAS READMITTED DUE TO INTESTINAL OBSTRUCTION AND UNDERWENT ADHESIOLYSIS AND BYPASS SURGERY, WHILE THE OTHER PATIENT HAD A DRAINAGE CATHETER ISSUE THAT REQUIRED FOREIGN BODY REMOVAL UNDER GENERAL ANESTHESIA. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE POSTOPERATIVE PANCREATIC FISTULA (POPF) RATE BETWEEN THE TWO GROUPS. SEVEN PATIENTS IN THE DA VINCI GROUP WERE READMITTED, INCLUDED THE ONE PATIENT PREVIOUSLY MENTIONED AS REQUIRING REOPERATION, ONE PATIENT WITH EPIGASTRIC DISCOMFORT, AND FIVE PATIENTS