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 AN ARTICLE THAT SUMMARIZED THE PRELIMINARY EXPERIENCE OF USING THE DA VINCI SURGICAL SYSTEM FOR ROBOT BREAST SURGERY (RBS) WAS PERFORMED. THE STUDY ANALYZED 151 PATIENTS UNDERGOING RBS BETWEEN SEPTEMBER OF 2022 TO JANUARY OF 2025. A TOTAL OF 40 PATIENTS UNDERWENT BREAST SURGERY USING THE DA VINCI SI SURGICAL SYSTEM AND 137 PATIENTS UNDERWENT BREAST SURGERY USING THE DA VINCI XI SURGICAL SYSTEM. A TOTAL OF 10 PATIENTS EXPERIENCED COMPLICATIONS INCLUDING THE FOLLOWING: 1 PATIENT EXPERIENCED AN INFECTION DUE TO SKIN BURNS AND LOST THE PROSTHESIS, 7 PATIENTS HAD PERIOPERATIVE SKIN REDNESS AND SWELLING WHICH IMPROVED AFTER TOPICAL NITROGLYCERIN OINTMENT WAS ADMINISTERED, AND 2 PATIENTS WERE DISCHARGED FROM THE HOSPITAL WITHOUT DISINFECTION AND DRESSING CHANGE OF THE DRAINAGE TUBE, RESULTING IN THE LOSS OF THE RETROGRADE INFECTION PROSTHESIS. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY INTUITIVE SURGICAL, INC. (ISI) DEVICE. ISI FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.

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 RADICAL TONSILLECTOMY SURGICAL PROCEDURE THAT A YELLOW CIRCLE OCCURRED WHEN INSTALLING THE CAMERA. THE CALLER STATED THAT THEY REMOVED THE CAMERA TO PERFORM A CERTAIN PART OF THE CASE, AND WHEN REINSTALLING THE CAMERA IN THE PATIENT SIDE CART (PSC), THE IMAGE HAD A YELLOW CIRCLE. THE INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) FOUND NO RELATED ERRORS IN THE SYSTEM LOGS. THE ISI TSE SUGGESTED TO RESEAT THE STERILE ADAPTER. THE CALLER STATED THEY ALREADY PERFORMED THAT. THE ISI TSE SUGGESTED TO REPLACE THE CAMERA, AND IF NO CHANGE, TO RE-DRAPE OR HARD POWER CYCLE THE SYSTEM. THE CALLER STATED THAT THE SURGEON WAS GOING TO BE DONE WITH THE SYSTEM AND WOULD BE COMPLETING THE CASE MANUALLY. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

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 TRANSTHORACIC ESOPHAGECTOMY - CHEST ANASTOMOSIS SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS FOUND TO HAVE A BROKEN TIP. THE CUSTOMER USED A SPARE INSTRUMENT TO CONTINUE WITH THE PROCEDURE. A FRAGMENT FROM THE INSTRUMENT REPORTEDLY FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT FUNCTIONALITY WAS INSPECTED BEFORE USE WITH NOTHING FOUND OUT OF THE ORDINARY. THE EVENT OCCURRED WHILE THE SURGEON WAS DISSECTING AND AFTER ACTIVATING THE HARMONIC ACE INSTRUMENT TO ONCE. THE SURGEON DID NOT NOTICE FUNCTIONALITY ISSUES DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL. THE INSTRUMENT WAS NOT REMOVED BEFORE BRAKEAGE. THE WRIST WAS STRAIGHTENED. THE STAFF DID NOT FEEL RESISTANCE DURING REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE NOTED TO THE CANNULA. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED VISUALLY IN THE SAME PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURES WERE DONE TO REMOVE

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 02/26/2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5151229 STATING: "SMALL SCREW FROM DAVINCI SYNCHROSEAL FELL OFF INSIDE PATIENT. SURGEON REMOVED SCREW IMMEDIATELY. DAVINCI REP MADE AWARE. DEVICE REMOVED FROM THE FIELD."

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 LOW ANTERIOR RESECTION WHICH A TEMPORARY ILEOSTOMY WAS PLACED IN THE LOWER RIGHT ABDOMEN. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED DA VINCI DEVICE MALFUNCTIONS OR ANY COMPLICATIONS. NO SIGNS OR SYMPTOMS OF BOWEL OBSTRUCTIONS HAVE BEEN REPORTED. THE PATIENT WAS FOUND WITH NARROWING OF THE ANUS THREE MONTHS LATER, AND AN OUTPATIENT PROCEDURE WAS PERFORMED. TWO MONTHS LATER, THE PATIENT WAS SCHEDULED FOR AN ILEOSTOMY TAKEDOWN BUT WAS FOUND WITH ANASTOMOSIS SITE NARROWING FROM THE PRE-PROCEDURAL COLOSCOPY. A SPHINCTEROTOMY WAS PERFORMED FOR THE ANAL STENOSIS ON AND THE PATIENT HAS BEEN REPORTED AS DOING WELL POST-PROCEDURALLY. THE STUDY INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DA VINCI DEVICES NOR THE 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 AFTER DA VINCI-ASSISTED NIPPLE AREOLAR SKIN SPARING MASTECTOMY, SENTINEL LYMPH NODE BIOPSY, AND LEFT BREAST RECONSTRUCTION WITH DEEP INFERIOR EPIGASTRIC PERFORATOR FLAP PROCEDURES, THE PATIENT PRESENTED WITH SYMPTOMS OF INFECTION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH NO COMPLICATIONS ON POSTOPERATIVE DAY 6. ON POSTOPERATIVE DAY 9, THE PATIENT PRESENTED WITH A FEVER OF 38 DEGREES CELSIUS OR HIGHER, SWELLING, HEAT, AND REDNESS IN THE LEFT BREAST, AND AN INCREASE IN THE AMOUNT OF DRAINAGE BY 3 TIMES WITH THE JACKSON-PRATT (JP) DRAIN. INTRAVENOUS (IV) ANTIBIOTICS WERE ADMINISTERED AFTER BLOOD, DRAINAGE FLUID, AND URINE CULTURES WERE PERFORMED IN THE EMERGENCY ROOM (ER) UNDER SUSPICION OF A POSTOPERATIVE INFECTION; MODERATE STAPHYLOCOCCUS AUREUS BACTERIA WERE FOUND IN THE DRAINAGE FLUID, AND NO BACTERIA WERE IDENTIFIED IN THE BLOOD OR URINE. THE INFECTION WAS CONFIRMED VIA A CHEST COMPUTED TOMOGRAPHY (CT), AND THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A WOUND INFECTION IN THE LEFT BREAST. IN ADDITION TO IV ANTIBIOTICS, THE PATIENT ALSO UNDERWENT A HEMATOMA EVACUATION SURGERY AT THIS TIME; THE HEMATOMA WAS LOCATED BELOW THE NIPPLE OF THE LEFT BREAST.

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) REVIEWED A JOURNAL ARTICLE THAT DESCRIBES A PROSPECTIVE SINGLE-CENTER COHORT STUDY THAT WAS PERFORMED. THE AIM OF THE STUDY WAS TO REVIEW THE FIRST 100 PATIENTS IN THE IMPLEMENTATION PHASE OF A NEW DA VINCI ROBOTIC LIVER SURGERY PROGRAM IN THEIR INSTITUTION TO ASSESS THE USE OF THE IWATE DIFFICULTY SCORES IN PREDICTING SURGICAL DIFFICULTY AND POSTOPERATIVE COMPLICATIONS. THE CONCLUSION OF THE STUDY FOUND THAT THE IWATE CATEGORIES HAD THE ABILITY TO PREDICT BOTH THE DIFFICULTY OF SURGERY AS WELL AS POSTOPERATIVE OUTCOMES WHEN ASSESSING THE COMPLEXITY OF ROBOTIC LIVER SURGERY, WHICH MAY AID IN APPROPRIATE PATIENT SELECTION. THE STUDY OCCURRED FROM NOVEMBER 2020 TO JANUARY 2023. THE ARTICLE NOTED THAT MAJOR LIVER RESECTIONS WERE PERFORMED IN 17% OF CASES, WHILE ATYPICAL RESECTIONS WERE THE MOST COMMON AT 49%, WITH THE REMAINING BEING ANATOMICAL SEGMENTECTOMIES (17%) AND LEFT LATERAL SECTIONECTOMIES (13%). THE MEDIAN BLOOD LOSS WAS 300 ML, AND 22 (22%) PATIENTS RECEIVED PERIOPERATIVE BLOOD TRANSFUSIONS. CONVERSION TO OPEN SURGERY OCCURRED IN 6% OF CASES DUE TO INTRAOPERATIVE BLEEDING TENDENCY (3 CASES), VASCULAR INFILTRATION (2 CASES), AND ADHESIONS (1 CA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE STUDY ASSESSED THE IMPACT OF THE DA VINCI SURGICAL SYSTEM ON THYROID SURGERY BY ANALYZING 104 ROBOTIC THYROIDECTOMY CASES PERFORMED FROM MARCH 2018 TO JANUARY 2022. THE SURGERIES UTILIZED BOTH THE SI AND XI MODELS OF THE DA VINCI SURGICAL SYSTEM IN SEQUENCE. THE STUDY AIMED TO DETERMINE IF, AFTER AN INITIAL LEARNING CURVE, THE SYSTEM WOULD REDUCE OPERATIVE TIMES WHILE MAINTAINING LOW COMPLICATION RATES, THEREBY ENHANCING PATIENT CARE. RESULTS SHOWED A DECREASE IN TRANSIENT POSTOPERATIVE COMPLICATIONS, WITH THE INCIDENCE OF VOCAL CORD PALSY FALLING FROM 5.4% IN EARLY CASES TO 1.5% IN LATER CASES. THERE WERE NO REPORTED PERMANENT INJURIES TO THE RECURRENT LARYNGEAL NERVE OR CASES OF PERMANENT HYPOPARATHYROIDISM. EARLY-PHASE ISSUES INCLUDED RARE INSTANCES OF POSTOPERATIVE HEMORRHAGE AND TRACHEAL INJURY. NO ISI- PRODUCTS RELATED MALFUNCTIONS WERE MENTIONED IN THE ARTICLES. THE STUDY CONCLUDED THAT AS SURGEONS GAINED EXPERIENCE, ROBOTIC ASSISTANCE IMPROVED SURGICAL PRECISION AND LED TO CONSISTENT OUTCOMES. HOWEVER, IT NOTED LIMITATIONS SUCH AS THE SMALL SAMPLE SIZE, SHORT FOLLOW-UP DURATION, AND LACK OF COMPARISON WITH OTHER THYROIDECTOMY APPROACHES. ALTHOUGH SURGERY DURATION REDUCE

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 CHOLECYSTECTOMY PROCEDURE THE SURGEON MENTIONED THE VESSEL SEALER INSTRUMENT (VSE) WAS NOT WORKING AT ALL. THE CIRCULATING NURSE TRIED TO TROUBLESHOOT THE ISSUE BY UNPLUGGING AND PLUGGING THE CORD OF THE VSE TO THE E100. WHEN SHE WENT TO DO THIS SHE SAW A SPARK AND FELT A SHOCK TO THE VERY PROXIMAL TIP OF THE FIRST DIGIT ON THE RIGHT HAND; ENERGY WAS NOT BEING DELIVERED TO THE VSE AT THIS TIME. AFTER PLUGGING THE CORD BACK INTO THE E100 THE VSE INSTRUMENT BEGAN TO FUNCTION AS NORMAL. THE PROCEDURE WAS COMPLETED AS PLANNED. THE NURSE DESCRIBED THE FEELING AS "A QUICK SHOCK WHEN YOU TOUCH A LIGHT SWITCH." A MARK WAS LEFT SMALLER THAN THE SIZE OF A PENCIL ERASER ON THE TIP/DISTAL PORTION OF FIRST DIGIT; NOW THE SKIN IS PEELING. SHE HAS NO PAIN. SHE DID NOT NEED TO SEE A PHYSICIAN OR MEDICAL TREATMENT DUE TO THE SHOCK EVENT. THE GENERATOR SETTINGS FOR THIS CASE ARE UNKNOWN. NO PHOTOS ARE AVAILABLE.

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 AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT'S BLADE SUDDENLY BROKE AND FELL OFF. A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED IN THE SAME PROCEDURE. THE CUSTOMER USED A SPARE INSTRUMENT TO CONTINUE WITH THE 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 DISTAL GASTRECTOMY PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP INSTRUMENT. FOLLOWING THIS, THE USER CONTINUED AND COMPLETED THE PROCEDURE WITH NO FURTHER ISSUES. IT IS UNKNOWN IF A FRAGMENT FELL INSIDE THE PATIENT DURING THE PROCEDURE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THERE WAS NO PATIENT INJURY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A POSSIBLE FOREIGN BODY. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACKUP INSTRUMENT. THE REPORTER DID NOT KNOW IF A FRAGMENT FELL INTO THE PATIENT. THE PATIENT UNDERWENT AN X-RAY EXAMINATION, AND NO ISSUE WAS DETECTED. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE OR ANYTHING OBSERVED OUT OF THE ORDINARY. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE INSTRUMENT'S FUNCTIONALITY DURING THE SURGICAL PROCEDURE. THE REPORTER WAS NOT AWARE IF THE INSTRUMENT COLLIDED WITH OTHER INSTRU

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 UPPER PULMONARY LOBECTOMY PROCEDURE, THERE WAS AN INSUFFICIENT SEAL AFTER USING THE SYNCHROSEAL INSTRUMENT AND BLEEDING OCCURRED. PRIOR TO SEALING THE ASCENDING BRANCH OF THE INTERLOBAR ARTERY TO THE UPPER LOBE (A2), THE "CENTER SIDE" OF THE VESSEL WAS CLIPPED. THEN USING THE SYNCHROSEAL INSTRUMENT TO LIGATE THE A2, A SEAL FUNCTION WAS PERFORMED, FOLLOWED BY A CUT FUNCTION. BLEEDING WAS THEN OBSERVED FROM THE PERIPHERY. THE SURGEON REPORTED WHEN USING THE SYNCHROSEAL FOR THE LIGATION, IT OCCURRED CLOSE TO A STAPLE LINE; AND THAT IT'S POSSIBLE THE INSUFFICIENT SEAL WAS CAUSED BY A METAL-LIKE OBJECT BETWEEN THE INSTRUMENT JAWS. THE BLEEDING WAS REPORTED AS A SMALL AMOUNT ON THE SPECIMEN SIDE, AND WAS RESOLVED BY SUTURE LIGATING THE VESSEL. THE PROCEDURE WAS COMPLETED AND THE PATIENT IS STILL IN THE HOSPITAL, BUT THERE HAVE BEEN NO POST-OPERATIVE 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 SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE UNIVERSAL SEAL FAILED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT A FRAGMENT FELL INTO THE PATIENT AND WAS ABLE TO BE RECOVERED DURING THE SAME SURGICAL PROCEDURE. THE FRAGMENT WAS ABLE TO BE REMOVED BY USING THE RAPALLO SURGICAL FORCEPS. THE CUSTOMER WAS ABLE TO CONFIRM THAT ALL FRAGMENTS WERE RETRIEVED BY CONFIRMING THE BROKEN AREA OF THE CANNULA SEAL WITH THE FRAGMENT. NO POST-OPERATIVE TESTS WERE CONDUCTED TO CHECK FOR REMAINING FRAGMENTS. THERE WAS NO PATIENT INJURY OR HARM.

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 LIVER RESECTION SURGICAL PROCEDURE, THE BLADE ON A HARMONIC ACE INSTRUMENT WAS BROKEN. THE CUSTOMER USED A SPARE INSTRUMENT TO COMPLETE THE PROCEDURE. A FRAGMENT REPORTEDLY FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROCEDURE, THE SCRUB TECHNICIAN NOTICED AS THEY WERE LOOKING INSIDE THE PELVIS OF THE PATIENT THAT A BLACK PIECE OF THE RUBBER PART OF THE UNIVERSAL SEAL HAD BROKEN OFF AND FELL INSIDE THE PATIENT. IT WAS UNKNOWN IF THE FRAGMENT WAS RETRIEVED OR NOT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. ACCORDING TO THE INITIAL REPORTER, THE EVENT DATE WAS BETWEEN THE DATES OF 11-DEC-2023 AND 15-DEC-2023. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO DAMAGE TO THE CANNULA SEAL PRIOR TO USE. THE SURGEON WAS UNSURE HOW THE PIECE ENDED UP INSIDE OF THE PATIENT BUT SUSPECTS IT MAY HAVE BEEN WHEN AN INSTRUMENT WAS BEING INSTALLED THROUGH THE CAP. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE UNSPECIFIED INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NOT BROKEN. HOWEVER, THE SURGICAL STAFF FELT RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE CANNULA SEAL WAS REMOVED AND REPLACED. THERE WAS NO 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: IN REVIEWING THE LITERATURE ARTICLE, A RETROSPECTIVE STUDY WAS CONDUCTED BASED ON COLLECTED CLINICOPATHOLOGICAL DATA OF A CONSECUTIVE SERIES OF MEN WITH LOCALIZED PROSTATE CANCER WHO UNDERWENT ROBOTIC-ASSISTED RADICAL PROSTATECTOMY (RARP) AT A SINGLE CENTER BETWEEN APRIL 2004 AND SEPTEMBER 2017. THE PRIMARY AIM OF THE STUDY WAS TO ASSESS LYMPH NODE (LN) YIELD, STRATIFIED BY SIDE AND ANATOMICAL REGION. THE SECONDARY OBJECTIVES WERE TO EXAMINE METASTATIC PATTERNS, COMPLICATION RATES, AND THE POTENTIAL THERAPEUTIC BENEFIT OF REMOVING REGIONAL METASTATIC LNS IN INDIVIDUALS WITH NODE-POSITIVE DISEASE. THE STUDY FOUND THAT AMONG PATIENTS WHO UNDERWENT EXTENDED PELVIC LYMPH NODE DISSECTION (EPLND) USING THE DA VINCI ROBOT ASSISTED APPROACH, SYMPTOMATIC LYMPHOCELES OCCURRED IN 2.1% OF CASES, WITH NONE OBSERVED IN MEN WHO DID NOT UNDERGO EPLND. THE STUDY ALSO REPORTED THAT CLAVIEN-DINDO GRADE IIIA AND GRADE IIIB COMPLICATIONS WERE 1.6% AND 3.3%, RESPECTIVELY, COMPARED TO 0.3% AND 1.1% IN PATIENTS WITHOUT PLND. FURTHERMORE, THE OVERALL COMPLICATION RATES (GREATER THAN OR EQUAL TO CLAVIEN-DINDO GRADE IIIA) INCREASED OVER TIME AMONG EPLND PATIENTS, WITH A TOTAL RATE OF 4.8%. NOTABLY, SIGNIFICA

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 WAS PERFORMED WHICH IS BASED ON A RETROSPECTIVE STUDY INVOLVING 144 PATIENTS WITH TYPE I¿IV HIATAL HERNIAS WHO UNDERWENT ELECTIVE DA VINCI-ASSISTED HERNIA REPAIR FROM 2016 TO 2019. THE STUDY AIMED TO ASSESS THE OUTCOMES OF A NOVEL TECHNIQUE FOR APPROXIMATING THE HIATUS USING V-LOCTM SUTURES, FOCUSING ON LENGTH OF STAY, READMISSION, AND RECURRENCE RATES. THE STUDY CONCLUDED THAT ROBOTIC REPAIR METHOD IS SAFE AND EFFECTIVE, WITH RESULTS COMPARABLE TO NATIONALLY PUBLISHED DATA ON LAPAROSCOPIC HIATAL HERNIA REPAIRS. THE AVERAGE PATIENT AGE WAS 61, WITH A MAJORITY BEING FEMALE. THE MOST COMMON COMPLICATION WAS CAPNOTHORAX (11%), WHICH REQUIRED PIGTAIL CATHETER PLACEMENT. NINETY-FIVE PERCENT OF PATIENTS WERE DISCHARGED HOME, AND 7% WERE READMITTED WITHIN 30 DAYS FOR VARIOUS ISSUES, INCLUDING DYSPHAGIA, EMESIS, MEDIASTINAL COLLECTION, INCISIONAL HERNIA, MALFUNCTIONING J-TUBE (A 3RD-PARTY MANUFACTURER PRODUCT), SUBCUTANEOUS EMPHYSEMA, AND SURGICAL SITE INFECTION. SIX RECURRENCES REQUIRED REOPERATION, PRIMARILY DUE TO SYMPTOMATIC RE-HERNIATION OR HIATUS ENLARGEMENT. THE STUDY CONCLUDED THAT ELECTIVE ROBOTIC HIATAL HERNIA REPAIR WITH FUNDOPLICATION AND PRIMAR

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REVIEW OF THIS LITERATURE ARTICLE THAT DESCRIBED A RETROSPECTIVE ANALYSIS AND AN UMBRELLA SYSTEMATIC REVIEW WAS PERFORMED. THE AIM OF THE STUDY WAS TO EXPLORE THE DIFFERENCES IN CLINICAL OUTCOMES OF PATIENTS UNDERGOING MINIMALLY INVASIVE CHOLECYSTECTOMY USING LAPAROSCOPIC AND ROBOTIC APPROACHES AT A SINGLE ACADEMIC CENTER WITH A NEWLY ESTABLISHED ROBOTIC SURGERY PROGRAM. THE CONCLUSION OF THE STUDY FOUND THAT ROBOTIC CHOLECYSTECTOMY IS FEASIBLE AND SAFE IN AN ACADEMIC SETTING, WITH CLINICAL OUTCOMES COMPARABLE TO LAPAROSCOPIC CHOLECYSTECTOMY. THE STUDY OCCURRED FROM NOVEMBER 2020 AND JANUARY 2022. THE ARTICLE NOTED THAT THE STUDY EXAMINED CHOLECYSTECTOMY PROCEDURES PERFORMED BY A SINGLE SURGEON, INCLUDING 61 LAPAROSCOPIC CHOLECYSTECTOMIES (LC) AND 42 ROBOTIC CHOLECYSTECTOMIES (RC), WITH RC PATIENTS BEING OLDER AND HAVING A LOWER BMI COMPARED TO LC PATIENTS. COMPLICATIONS INCLUDED INTRA-ABDOMINAL ABSCESSES (3 CASES) AND A SURGICAL SITE INFECTION (1 CASE), WITH NO CONVERSIONS TO OPEN PROCEDURES, BILE LEAKS, SMALL BOWEL OBSTRUCTIONS, OR BLOOD TRANSFUSIONS NEEDED. THE ARTICLE DOCUMENTED THAT THERE WERE SEVERAL LIMITATIONS TO THIS STUDY. THESE INCLUDE ITS SINGLE-SURGEON SCOPE, MAKING IT

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 LOW ANTERIOR RESECTION (LAR) PROCEDURE, THE HARMONIC ACE INSTRUMENT TIP BROKE. A FRAGMENT BROKE OFF FROM THE INSTRUMENT AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE USER COMPLETED THE PROCEDURE USING A BACKUP HARMONIC ACE INSTRUMENT WITH NO FURTHER ISSUE REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT(S) WERE ALL CONFIRMED TO BE RETRIEVED THROUGH VISUALIZATION OF AN ENDOSCOPE BY THE SURGEON, NURSE, AND SURGICAL ASSISTANT. THERE WAS NO ADDITIONAL PROCEDURE OR POST-OPERATIVE TEST PERFORMED. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE INSTRUMENT WAS IN USE FOR HALF AN HOUR PRIOR TO BREAKING AND WHILE THE SURGEON WAS DISSECTING. THERE WAS NO ISSUE WITH FUNCTIONALITY OF THE INSTRUMENT AND NO INSTRUMENT COLLISION. THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE PRIOR TO THE BREAKAGE BUT THERE WAS NO RESISTANCE UPON REMOVAL. UPON FINAL REMOVAL OF THE INSTRUMENT, THERE WAS NO RESISTANCE THROUGH THE CANNULA, NO DAMAGE TO THE CANNULA, AND NO FURTHER DAMAGE TO THE INSTRUMENT. THE PATI

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 THYROIDECTOMY PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT WAS BROKEN. THE FRAGMENT FELL INSIDE THE PATIENT¿S CAVITY AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF THE SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS FOUND. AFTER THE CUSTOMER USED THE INSTRUMENT FOR 20 TO 30 MINUTES TO GRASP TISSUE, THE INSTRUMENT BROKE AND THE FRAGMENT(S) FELL INSIDE THE PATIENT. ALL THE FRAGMENTS WERE RETRIEVED DURING SAME PROCEDURE AND CONFIRMED BY MATCHING THE FRAGMENTS TO THE INSTRUMENT. POST-OPERATIVE TESTS WERE NOT PERFORMED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT AND THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). UPON FINAL REMOVAL OF THE INSTRUMENT, THE INSTRUMENT'S WRIST WAS STRAIGHTENED, AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. NO OTHER

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 PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED BREATHING DIFFICULTIES AND NODAL TACHYCARDIA. AN ELECTROCARDIOGRAM (ECG) AND A CORONARY ANGIOGRAM (CAG) WERE PERFORMED; THE ECG SHOWED SINUS TACHYCARDIA AND ST-ELEVATION, INDICATING A POSSIBLE ANTERIOR WALL INJURY. THE PATIENT WAS ADMINISTERED NITROGLYCERIN, "STATINS" AND OTHER HEART RATE LOWERING MEDICATIONS. TWO DAYS LATER, THE PATIENT'S SYMPTOMS HAD RESOLVED AND AFTER AN ADDITIONAL TWO DAYS MORE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND HAS SINCE NOT RETURNED. IT WAS REPORTED THAT THE BREATHING DIFFICULTIES ARE BELIEVED TO BE UNRELATED TO ANY MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES OCCUR DURING THE SURGICAL 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: 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 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 — 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: DURING A REVIEW OF A CLINICAL LITERATURE ARTICLE THAT COMPARED SURVIVAL AND PERIOPERATIVE OUTCOMES OF OPEN VERSUS ROBOTIC RETROPERITONEAL LYMPH NODE DISSECTION (RPLD), THE FOLLOWING COMPLICATIONS WERE DOCUMENTED. A TOTAL OF 178 PATIENTS UNDERWENT PRIMARY RPLD IN ONE SINGLE INSTITUTION BETWEEN 1990 AND 2022, 137 PATIENTS UNDERWENT OPEN-RPLD AND 41 PATIENTS UNDERWENT ROBOTIC-RPLD. AFTER PROPENSITY SCORE MATCHING (PSM), 38 PATIENTS IN THE OPEN-RPLD WERE MATCHED WITH 26 PATIENTS IN THE ROBOTIC-RPLD GROUP. ROBOTIC-RPLD WAS ASSOCIATED WITH LOWER BLOOD LOSS AND STATISTICALLY SHORTER LENGTH OF STAY, COMPARED TO THE OPEN-RPLD GROUP. THE OPERATIVE TIME WAS SIGNIFICANTLY LONGER FOR THE ROBOTIC APPROACH, BUT DECREASED AS SURGEON'S EXPERIENCES GAINED. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS OR DA VINCI DEVICE MALFUNCTION OCCURRED IN ANY OF THE PROCEDURES ACCORDING TO THE ARTICLE AUTHOR. THERE WERE TEN (24%) POST-OPERATIVE COMPLICATIONS OCCURRED IN ROBOTIC-RPLD GROUP COMPARED TO 31 (23%) COMPLICATIONS IN THE OPEN-RPLD GROUP. IN THE ROBOTIC-RPLD GROUP, ONE (2.4%) COMPLICATION OF ASCITES THAT REQUIRED PARACENTESIS WAS REPORTED AS CLAVIDEN-DINDO IIIA, WHILE THE REST OF THE COMPLICATIONS WERE CL

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 PROCEDURE, THE CANNULA SEAL ACCESSORY RIPPED WHILE THE CUSTOMER WAS INSERTING MESH INSIDE THE PATIENT WITH A GRASPER INSTRUMENT. DURING INSERTION OF THE GRASPER, THE CUSTOMER SAW A BLUE FRAGMENT/PIECE INSIDE THE PATIENT. THE CANNULA SEAL WAS INSPECTED, AND IT WAS NOTED TO BE TORN. IT IS UNKNOWN IF THERE WAS AN INSTRUMENT/ACCESSORY COLLISION. THE INSTRUMENT WRIST WAS STRAIGHTENED DURING REMOVAL. THE FRAGMENT WAS RETRIEVED USING A BACK-UP INSTRUMENT DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. THERE ARE NO PHOTOGRAPHIC IMAGES AVAILABLE.

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 HARMONIC ACE INSTRUMENT HAD A RECOGNITION ISSUE AND A FRAGMENT DETACHED FROM THE INSTRUMENT. THE FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH A NURSE FROM THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED BEFORE USE WITH NOTHING FOUND OUT OF THE ORDINARY. IT IS UNKNOWN WHAT SURGICAL TASK WAS BEING PERFORMED WHEN THE FRAGMENT FELL INSIDE THE PATIENT. THE SURGEON DOES NOT KNOW WHAT CAUSED THE ISSUE. THE ISSUE WITH THE INSTRUMENT OCCURRED ABOUT 10 MINUTES AFTER THE PROCEDURE STARTED. THE SURGEON DID NOT NOTICE FUNCTIONALITY ISSUES DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL. THE INSTRUMENT WAS NOT REMOVED BEFORE BRAKEAGE AND THE WRIST WAS STRAIGHTENED. THE STAFF DID NOT FEEL RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE NOTED TO THE CANNULA. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED BY VISUAL INSPECTION. NO ADDITIONAL SURGICAL P

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 MYOMECTOMY PROCEDURE, THE SCRUB TECH NOTICED WHILE LOOKING INSIDE OF THE PELVIS OF THE PATIENT THAT A BLACK PIECE OF THE RUBBER PART OF THE UNIVERSAL SEAL FELL OFF INTO THE PATIENT. A GRASPER WAS UTILIZED TO REMOVE THE FRAGMENT FROM THE PATIENT. NO FRAGMENT WAS LEFT BEHIND INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO NOTED DAMAGE PRIOR TO USE OF THE CANNULA SEAL. THE SURGEON WAS UNSURE WHEN THE FRAGMENT FELL INSIDE THE PATIENT. HOWEVER, THE SURGEON SUSPECTED IT MAY HAVE BEEN OCCURRED WHEN INSERTING AN INSTRUMENT ONTO AN ARM AND THROUGH THE CAP OF THE CANNULA SEAL. THE PROCEDURE HAD BEEN IN PROGRESS FOR APPROXIMATELY 45 MINUTES WHEN THE EVENT OCCURRED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. IT WAS REPORTED THAT AN INSTRUMENT DID NOT BREAK. THE CANNULA SEAL WAS REMOVED AND REPLACED. THE AREA OF CANNULA SEAL WAS NOTED TO

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 RETROSPECTIVE REVIEW OF PATIENTS WHO UNDERWENT ELECTIVE LAPAROSCOPIC OR ROBOT-ASSISTED LAPAROSCOPIC HIATAL HERNIA (HH) REPAIR BETWEEN JANUARY 2020 AND DECEMBER 2022 WAS CONDUCTED TO EVALUATE THE CLINICAL EFFECTS OF ROBOT-ASSISTED LAPAROSCOPIC SURGERY (RALS) AND CONVENTIONAL LAPAROSCOPIC SURGERY (CLS) IN TREATING HH IN CHILDREN. FIFTY-FOUR PATIENTS WERE INITIALLY ENROLLED IN THE STUDY; HOWEVER, NINE PATIENTS WERE EXCLUDED DUE TO FACTORS SUCH AS GASTROESOPHAGEAL REFLUX (GER), SERIOUS DISEASES, AND INCOMPLETE CLINICAL DATA. ULTIMATELY, 46 PATIENTS MET THE INCLUSION CRITERIA, WITH 25 (54.3%) UNDERGOING CLS (GROUP 1) AND 21 UNDERGOING RALS (GROUP 2). THE AVERAGE AGE FOR GROUP 1 WAS 2.2 YEARS, WHILE FOR GROUP 2, IT WAS 3.3 YEARS. THE MEAN FOLLOW-UP PERIOD WAS 18 MONTHS FOR GROUP 1 AND 13 MONTHS FOR GROUP 2. POSTOPERATIVE COMPLICATIONS WERE ASSESSED, WITH PNEUMONIA BEING THE MOST COMMON IN BOTH GROUPS¿OCCURRING IN 5 PATIENTS (20%) IN GROUP 1 AND 2 PATIENTS (9.5%) IN GROUP 2. EACH GROUP HAD ONE PATIENT READMITTED DUE TO REPEATED VOMITING WITHIN ONE MONTH POST-OPERATION, BOTH OF WHOM RECOVERED WITH CONSERVATIVE TREATMENT. ADDITIONAL COMPLICATIONS INCLUDED ONE CASE OF PNEUMOTHORAX IN 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: MY MOTHER SUFFERED SERIOUS COMPLICATIONS DURING A FUNDOPLICATION SURGERY USING THE DA VINCI ROBOT MADE MY INTUITIVE SURGICAL. A PRIMARY BLOOD VESSEL TO HER STOMACH WAS SEVERED CAUSING THE ORGAN TO DIE. SHE HAS CONTINUED TO HAVE ISSUES WITH PERFUSION TO HER INTESTINES REQUIRING MULTIPLE FOLLOW UP PROCEDURES TO REMOVE MORE NECROTIC TISSUE. AT THIS POINT WE ARE UNSURE IF SHE WILL SURVIVE AND IF SHE DOES SHE WILL BE DEPENDENT ON OTHERS FOR HER CARE FOR THE REMAINDER OF HER LIFE. SHE WAS PREVIOUSLY AN ACTIVE 65 YO GRANDMOTHER. THIS MATTER NEEDS TO BE INVESTIGATED FULLY. THE PROCEDURE WAS DONE BY DR (B)(6) AT (B)(6) HOSPITAL IN (B)(6). PROCEDURE DATE IS (B)(6) 2023.

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 INSTRUMENT'S BLADE SUDDENLY BROKE. FRAGMENTS WERE REPORTED TO HAVE FALLEN INSIDE THE PATIENT AND WERE RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER USED A SPARE INSTRUMENT TO COMPLETE THE PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

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 INSTRUMENT TIP WAS BROKEN. A FRAGMENT FELL INSIDE THE PATIENT AND THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE HARMONIC ACE INSTRUMENT WAS INSPECTED BEFORE USE. THE INSTRUMENT DID NOT COLLIDE WITH OTHER INSTRUMENTS OR TOOLS.

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 RADICAL HYSTERECTOMY SURGICAL PROCEDURE, THE USER OBSERVED AN INSTRUMENT RECOGNITION ISSUE WITH THE HARMONIC ACE INSTRUMENT. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP. FOLLOWING THIS, THE USER CONTINUED AND COMPLETED THE PROCEDURE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT A FRAGMENT OF THE TEFLON PAD PIECE WAS FOUND AND RETRIEVED. AN X-RAY TEST WAS PERFORMED TO CHECK FOR REMAINING FRAGMENTS INSIDE THE PATIENT. THERE WAS NO INSTRUMENT COLLISION.

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 VENTRAL HERNIA TRANSABDOMINAL PRE-PERITONEAL (TAPP) SURGICAL PROCEDURE, THE UNIVERSAL SEAL INSUFFLATION PORT BROKE OFF DURING CASE. A FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

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 LIVER RESECTION SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT SLEEVE ON THE JOINT CAME OFF IN THE PATIENT AND WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED.

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 SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY, INSTALLED ON AN MCS INSTRUMENT, FELL OFF INSIDE THE PATIENT. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING SAME PROCEDURE AND THE CUSTOMER MOVED ON TO ANOTHER MCS INSTRUMENT TO CONTINUE THE PROCEDURE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) INQUIRED IF THE MCS TIP COVER ACCESSORY WAS CORRECTLY INSTALLED, BUT THE CUSTOMER WAS NOT ABLE TO VERIFY.

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 STUDY WHICH COMPARED ROBOT-ASSISTED VERSUS LAPAROSCOPIC LYMPH NODE DISSECTION PROCEDURES IN PATIENTS WITH GYNECOLOGIC MALIGNANCIES, WAS SUMMARIZED IN A LITERATURE ARTICLE. THE ARTICLE COMPARES THE SURGICAL OUTCOMES AND COMPLICATIONS FOR PELVIC LYMPH NODE DISSECTION (PLND) PERFORMED THROUGH CONVENTIONAL LAPAROSCOPIC SURGERY (CLS) VERSUS ROBOT-ASSISTED SURGERY (RAS) IN PATIENTS WITH GYNECOLOGIC MALIGNANCIES OVER A PERIOD OF APPROXIMATELY EIGHT YEARS. THERE WERE 731 PATIENTS WITH GYNECOLOGIC MALIGNANCIES WHO UNDERWENT TRANSPERITONEAL PLND, INCLUDING 460 AND 271 IN THE CLS AND RAS GROUPS, RESPECTIVELY. THE BLOOD LOSS, AND NUMBER OF RESECTED LYMPH NODES WERE 110 +/- 88 ML, AND 45 +/- 17, RESPECTIVELY, IN THE RAS GROUP AND 89 +/- 78 ML, AND 38 +/- 16, RESPECTIVELY, IN THE CLS GROUP. IT WAS CONSIDERED THAT THE DIFFERENCE IN BLOOD LOSS (APPROXIMATELY 20 ML) WAS WITHIN A CLINICALLY ACCEPTABLE RANGE AND RAS RESULTS IN THE RESECTION OF A GREATER NUMBER OF PELVIC LYMPH NODES. THE RATE OF CLAVIEN-DINDO GRADE >/= III COMPLICATIONS WAS 6.3% AND 8.7% IN THE RAS AND CLS GROUPS, RESPECTIVELY. ONE PATIENT IN THE RAS GROUP, COMPARED WITH 4 IN THE CLS GROUP, HAD AN INTRAOPERATIVE VASCULAR COMPLICATIO

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 STUDY UNDERWENT A DA VINCI-ASSISTED BILATERAL NIPPLE SPARING MASTECTOMY FOLLOWED BY A NON-ROBOTIC IMMEDIATE BREAST RECONSTRUCTION. IT WAS REPORTED THAT THE PATIENT'S LEFT BREAST SHOWED ERYTHEMA AND SWELLING APPROXIMATE THREE MONTHS LATER, AND EXTENDED TO THE ENTIRE BREAST IN A PATCHY PATTERN. THE PATIENT WAS PLACED ON A TRIPLE IV ANTIBIOTIC REGIMEN AND THE LEFT BREAST ERYTHEMA WAS NOTED TO HAVE IMPROVED. THERE WAS NO MENTION OF MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE 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 HEPATECTOMY SURGICAL PROCEDURE, THE SLEEVE ON THE JOINT CAME OFF A SYNCHROSEAL INSTRUMENT AND FELL INSIDE THE PATIENT. THE SLEEVE JOINT WAS RETRIEVED INTRAOPERATIVELY DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED USING A BACKUP INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS WERE AVAILABLE REGARDING THE REPORTED EVENT.

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 RADICAL PROSTATECTOMY W/ LYMPHADENECTOMY SURGICAL PROCEDURE, USING AN DA VINCI SINGLE PORT SYSTEM, APPROXIMATELY 10 MINUTES AFTER INITIALIZATION, THE SYSTEM DISPLAYED RECOVERABLE ERROR CODE 307 ON PATIENT SIDE MANIPULATOR (PSM) 2. TROUBLESHOOTING WAS PERFORMED. THE SYSTEM WAS RESTARTED, AND A DISABLED ARM PROMPT WAS DISPLAYED. FURTHER TROUBLESHOOTING THROUGH A HARD SYSTEM POWER CYCLE CLEARED THE SYSTEM PROMPT; HOWEVER, WITHIN 1 MINUTE, THE ERROR APPEARED AGAIN. THE SURGEON ELECTED TO CONVERT TO FROM DA VINCI SINGLE PORT SYSTEM TO THE MULTI-PORTS SYSTEM. THERE WAS NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM OPERATED NORMALLY AFTER INITIALIZATION.

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 GENERAL SURGICAL PROCEDURE, SP SYSTEM HAD A UNCOVERABLE FAULT ASSOCIATED WITH THIRD INSTRUMENT DRIVE. THE SURGEON DESCRIBED THE EVENT AS THE INSTRUMENT ¿FREEZING¿. THE SURGEON CONVERTED TO DV XI TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS IDENTIFIED PRIOR TO START OF PROCEDURE. THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING UP AND IT INITIALLY DID POWER ON WITHOUT ERRORS. THE TROUBLESHOOTING WAS NOT COMPLETED, AND IT WAS A NON-RECOVERABLE FAULT THAT REQUIRED A FIELD TECH TO COME OUT. PATIENT WAS ALREADY UNDER ANESTHESIA, SO THE XI SYSTEM WAS BROUGHT IN TO CONTINUE. THE PROCEDURE WAS ROBOTICALLY COMPLETED WITH THE XI SYSTEM. ADDITIONAL PORTS WERE PLACED TO COMPLETE THE PROCEDURE. THE PATIENT DID TOLERATE THE CHANGE AND NO PATIENT INJURY OCCURRED.

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, PHYSICAL DAMAGE WAS OBSERVED ON THE HARMONIC ACE INSTRUMENT. THE INITIAL REPORTER INDICATED THAT THE INSTRUMENT HAD AN "INTERRUPTED TOOTH" AND A FRAGMENT FELL FROM THE INSTRUMENT FELL INSIDE THE PATIENT. THE INITIAL REPORTER ALSO INDICATED THAT THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY USING A BACKUP HARMONIC ACE INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORT INDICATED THAT NO DEVICE LANDED INSIDE THE PATIENT; HOWEVER, A FRAGMENT WAS REMOVED ENDOSCOPICALLY. THERE WERE NO 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 AFTER A DA VINCI-ASSISTED BILATERAL NIPPLE SPARING MASTECTOMY (NSM) PROCEDURE FOR THE PATIENT'S RIGHT BREAST CANCER AND LEFT BREAST PROPHYLACTICALLY, THE PATIENT EXPERIENCED POST-OPERATIVE HYPOTENSION PRIOR TO DISCHARGE THAT REQUIRED A BLOOD TRANSFUSION. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT ANY DEVICE MALFUNCTIONS REPORTED. THE INTRA-OPERATIVE BLOOD LOSS WAS REPORTED AS 170ML BUT WAS NOT AN UNEXPECTED VOLUME FOR THE TYPE OF PROCEDURE. NO MEDICAL OR SURGICAL INTERVENTION WAS RENDERED TO STOP THE BLEEDING. ON THE NIGHT OF THE PROCEDURE, THE PATIENT WAS NOTED TO BE HYPOTENSIVE. ON POST-OPERATIVE DAY #2, LAB RESULTS INDICATED A HEMOGLOBIN LEVEL OF 6.6. ONE UNIT OF PACKED RED BLOOD CELLS (PRBC) WAS TRANSFUSED THE NEXT DAY AND THE HYPOTENSION WAS RESOLVED WITH A HEMOGLOBIN LEVEL OF 8.8. THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY #3. THE SURGEON BELIEVED THE CAUSE OF THE HYPOTENSION WAS DUE TO INTRA-OPERATIVE BLOOD LOSS AND HEMODILUTION. THREE MONTHS LATER, THE PATIENT WAS FOUND TO HAVE A RIGHT AXILLARY MASS. AN EXCISION OF THE MASS AND A REVISION OF THE BILATERAL BREAST RECONSTRUCTION WAS PERFORMED ON (B)(6) 2024. THE CAUSE OF THE MASS IS UNKNOWN AT