Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE CLINICAL STUDY TRIAL CASE UNEXPECTED VIDEO QUALITY WAS OBSERVED ON URETEROSCOPE. THE UNEXPECTED VIDEO QUALITY CONSISTED OF BLURRINESS ON THE SYSTEM DISPLAY. THE BLURRY VISION WAS ONLY OBSERVED DURING MINI-PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE OF THE PRODUCT WORKFLOW, NAMELY DURING URETEROSCOPE DRIVING WITH THE LASER DRIVER COMPONENT CONNECTED. UPON REPLACEMENT OF THE URETEROSCOPE, NO FURTHER VIDEO ISSUES WERE OBSERVED AND THE USER COMPLETED THE CASE. UNDER PRELIMINARY INVESTIGATION THE URETEROSCOPE WAS EXAMINED UNDER MAGNIFICATION, AT WHICH TIME IT WAS DISCOVERED THAT THE TOP LAYER OF THE CAMERA LENS WAS MISSING. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

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.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SURGEON CAUSED A TEAR OF THE SPINAL MEMBRANE(DUROTOMY) DUE TO DEVIATED PLACEMENT OF THE LEFT PEDICLE SCREW. THE SURGEON FELT THE CAUSE OF THE DEVIATED SCREW PLACEMENT WAS DUE TO A MALFUNCTION WITH THE GUIDANCE SYSTEM. THE PATIENT'S SPINAL CORD MEMBRANE WAS TORN APART, RESULTING IN SIGNIFICANT PERMANENT INJURIES INCLUDING EPIDURAL HEMATOMA, INTRADURAL COMPRESSIVE FLUID COLLECTION, SEVERED LUMBAR NERVE ROOTS, LOSS OF USE OF LIMBS, FOOT DROP, INCONTINENCE, AND OTHER INJURIES CONSISTENT WITH CAUDA EQUINA SYNDROME. THE PATIENT HAS ALSO EXPERIENCED PAIN AND MENTAL ANGUISH.

VELYS — 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 TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHILE USING THE ROBOTIC-ASSISTED SOLUTION SATELLITE STATION DEVICE IT WAS NOTICED THAT THE ANTERIOR CUT WAS OFF. IT WAS ALSO REPORTED THAT THE ROBOTIC ASSISTED BASE STATION DEVICE WAS TAKING A LONG TIME TO BOOT UP AND THE POWER CORD WOULD NOT STAY SECURELY ATTACHED TO THE BASE STATION. IT WAS REPORTED THAT THE SYSTEM WAS WORKING HOWEVER THE POWER CORD IS CAUSING FRUSTRATION WITH THE SYSTEM SHUTTING DOWN. THERE WERE NO DELAYS IN THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

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.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT A SURGEON DECIDED TO BRING A PATIENT BACK TO REVISE TWO SCREWS. THE SCOPE WAS TO IMPLANT EIGHT SCREWS FROM L2 TO L5. THE SITE INITIALLY ATTEMPTED TO REGISTER USING CT TO FLUORO, BUT THAT REGISTRATION FAILED SIX TIMES DUE TO THREE TITANIUM CAGES BEING IN THE FIELD OF VIEW AND THE PATIENT BEING VERY LARGE. THE SURGEON EXPECTED TO FAIL THAT REGISTRATION DUE TO THE CAGES IN THE VIEW AND THE PATIENT BEING VERY LARGE. THE SURGEON HAD BEEN SUCCESSFUL IN ACQUIRING A PASSING REGISTRATION IN THIS CIRCUMSTANCE BEFORE WHICH IS WHY THEY KEPT TRYING TO GET A REGISTRATION. AFTER THE SURGEON FELT LIKE THEY HAD GIVEN CT TO FLUORO REGISTRATION A CHANCE, THE SITE RESORTED TO USING SCAN AND PLAN INSTEAD. SCAN AND PLAN REGISTRATION WAS SUCCESSFUL. THE SURGEON INSERTED THE EIGHT SCREWS AND COMPLETED THE CASE. THE SURGEON VERIFIED THE SCREW PLACEMENT AFTER THE CASE USING FLUORO. HOWEVER, THE SURGEON ORDERED A CT OF THE PATIENT AFTER THE CASE, WHICH MADE THEM REALIZE TWO OF THE EIGHT SCREWS WERE TOO SUPERIOR. THE TRAJECTORY WAS DEVIATED 3.5 MM TO 10MM. THE SURGEON THEN DECIDED TO SCHEDULE

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PATIENT WAS SCHEDULED FOR A LUMBAR FUSION WITH SPINAL INSTRUMENTATION USING COMPUTER NAVIGATION AND ROBOTIC ASSISTANCE USING THE GLOBUS MEDICAL EXCELSIUS 3D IMAGING SYSTEM. I HAD BEEN NOTIFIED BY THE GLOBUS REPRESENTATIVE ON THE MORNING OF SURGERY THAT THERE WAS A POTENTIAL PROBLEM WITH THE BATTERY SUPPLY OF THE GLOBUS IMAGING SYSTEM BUT THAT IT HAD BEEN ADDRESSED BY THE ENGINEERS AND THERE SHOULD BE NO PROBLEM. I WAS TOLD THAT EVEN IF THERE WAS A BATTERY ISSUE THE SYSTEM COULD RUN FROM ELECTRICAL POWER FROM THE WALL. ONCE THE PATIENT WAS ASLEEP AND THE EXPOSURE TO THE SPINE WAS COMPLETE, THE GLOBUS IMAGING SYSTEM WAS BROUGHT IN FOR OBTAINING THE IMAGES. IT IMMEDIATELY SHUT DOWN AND COULD NOT BE RESTARTED. AS A RESULT I WAS UNABLE TO PROCEED WITH THE COMPUTER NAVIGATION OR ROBOTIC ASSISTANCE THAT I HAD EXPLAINED TO THE PATIENT. MY OPTIONS WERE TO EITHER CANCEL THE SURGERY AND CLOSE THE WOUND TO RETURN ANOTHER DAY ONCE THE SYSTEM WAS WORKING OR PROCEED WITHOUT THE NAVIGATION AND ROBOTIC ASSISTANCE. I CHOOSE TO PROCEED WITH THE SURGERY USING THE TRADITIONAL APPROACH WITHOUT NAVIGATION OR ROBOTICS. FORTUNATELY THE SURGERY WENT WELL WITHOUT COMPLICATIONS. I WAS ABLE TO CONTINUE WIT

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PATIENT WAS SCHEDULED FOR A LUMBAR FUSION WITH SPINAL INSTRUMENTATION USING COMPUTER NAVIGATION AND ROBOTIC ASSISTANCE USING THE GLOBUS MEDICAL EXCELSIUS 3D IMAGING SYSTEM. I HAD BEEN NOTIFIED BY THE GLOBUS REPRESENTATIVE ON THE MORNING OF SURGERY THAT THERE WAS A POTENTIAL PROBLEM WITH THE BATTERY SUPPLY OF THE GLOBUS IMAGING SYSTEM BUT THAT IT HAD BEEN ADDRESSED BY THE ENGINEERS AND THERE SHOULD BE NO PROBLEM. I WAS TOLD THAT EVEN IF THERE WAS A BATTERY ISSUE THE SYSTEM COULD RUN FROM ELECTRICAL POWER FROM THE WALL. ONCE THE PATIENT WAS ASLEEP AND THE EXPOSURE TO THE SPINE WAS COMPLETE, THE GLOBUS IMAGING SYSTEM WAS BROUGHT IN FOR OBTAINING THE IMAGES. IT IMMEDIATELY SHUT DOWN AND COULD NOT BE RESTARTED. AS A RESULT I WAS UNABLE TO PROCEED WITH THE COMPUTER NAVIGATION OR ROBOTIC ASSISTANCE THAT I HAD EXPLAINED TO THE PATIENT. MY OPTIONS WERE TO EITHER CANCEL THE SURGERY AND CLOSE THE WOUND TO RETURN ANOTHER DAY ONCE THE SYSTEM WAS WORKING OR PROCEED WITHOUT THE NAVIGATION AND ROBOTIC ASSISTANCE. I CHOOSE TO PROCEED WITH THE SURGERY USING THE TRADITIONAL APPROACH WITHOUT NAVIGATION OR ROBOTICS. FORTUNATELY THE SURGERY WENT WELL WITHOUT COMPLICATIONS. I WAS ABLE TO CONTINUE WIT

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PATIENT WAS SCHEDULED FOR A LUMBAR FUSION WITH SPINAL INSTRUMENTATION USING COMPUTER NAVIGATION AND ROBOTIC ASSISTANCE USING THE GLOBUS MEDICAL EXCELSIUS 3D IMAGING SYSTEM. I HAD BEEN NOTIFIED BY THE GLOBUS REPRESENTATIVE ON THE MORNING OF SURGERY THAT THERE WAS A POTENTIAL PROBLEM WITH THE BATTERY SUPPLY OF THE GLOBUS IMAGING SYSTEM BUT THAT IT HAD BEEN ADDRESSED BY THE ENGINEERS AND THERE SHOULD BE NO PROBLEM. I WAS TOLD THAT EVEN IF THERE WAS A BATTERY ISSUE THE SYSTEM COULD RUN FROM ELECTRICAL POWER FROM THE WALL. ONCE THE PATIENT WAS ASLEEP AND THE EXPOSURE TO THE SPINE WAS COMPLETE, THE GLOBUS IMAGING SYSTEM WAS BROUGHT IN FOR OBTAINING THE IMAGES. IT IMMEDIATELY SHUT DOWN AND COULD NOT BE RESTARTED. AS A RESULT I WAS UNABLE TO PROCEED WITH THE COMPUTER NAVIGATION OR ROBOTIC ASSISTANCE THAT I HAD EXPLAINED TO THE PATIENT. MY OPTIONS WERE TO EITHER CANCEL THE SURGERY AND CLOSE THE WOUND TO RETURN ANOTHER DAY ONCE THE SYSTEM WAS WORKING OR PROCEED WITHOUT THE NAVIGATION AND ROBOTIC ASSISTANCE. I CHOOSE TO PROCEED WITH THE SURGERY USING THE TRADITIONAL APPROACH WITHOUT NAVIGATION OR ROBOTICS. FORTUNATELY THE SURGERY WENT WELL WITHOUT COMPLICATIONS. I WAS ABLE TO CONTINUE WIT

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THERE IS A RED LIGHT ON THE ROBOT, AND THE SYSTEM CAMERA REPORTED BING BUMPED.

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

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT AFTER THE SCREW INSERTIONS AND DURING DECOMPRESSION, THE SURGEON NOTICED A DURAL TEAR DUE TO A SCREW BEING INSERTED TOO MEDIALLY. THE SURGEON REINSERTED THE SCREW WITHOUT USING THE GUIDANCE SYSTEM. THE SURGEON ALLEGED THE TEAR WAS CAUSED BY THE MEDIAL SCREW AND THAT THE SCREW WAS NOT INSERTED ACCORDING TO THE PLAN. ALL SCREWS WERE PLACED CORRECTLY EXCEPT FOR THE LAST SCREW, WHICH WAS ON L1. THE DEVIATION WAS LESS THAN 3.5MM. THE SCREW WAS REPOSITIONED VIA FREEHAND. THE PATIENT EXPERIENCED WEAKNESS IN BOTH LEGS, BUT IS GETTING BETTER. THE PROCEDURE WAS NOT DELAYED.

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

ExcelsiusGPS — 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 REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM DUE TO ADVERSE PATIENT EFFECTS.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR. (B)(6) WAS DOING A T3-T12 PEDIATRIC SCOLIOSIS PATIENT. SIGNIFICANT CORONAL AND SAGITTAL DEFORMITY AT MULTIPLE LEVELS. WE WERE USING A 12INCH C-ARM. MERGE FAILED AFTER MULTIPLE ATTEMPTS OF HAVING THE X-RAY TECH WAG THE C-ARM IN LATERAL, RAINBOW IN A/P, AND TRY OBLIQUE IN LATERAL AT HIGH LEVELS. TRIED MULTIPLE LATERALS AND A/P WITH NO AVAIL. SURGEON WAS VERY PATIENT AND GAVE US THE TIME BUT EVENTUALLY BAILED ON THE ROBOT. HE PROCEEDED WITH DOING THE CASE FREE HAND.

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

Monarch Platform — 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 MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX IN THE RIGHT LUNG. A CHEST TUBE WAS PLACED AND PATIENT WAS HOSPITALIZED. THE FOLLOWING DAY THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS RELEASED. THE PHYSICIAN STATED THAT THE SCOPE APPEARED TO BE KINKED AND THE PHYSICIAN ELECTED TO ABORT THE CASE.

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.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT REPORTED THAT THE NAVIGATION WAS NOT MATCHING UP WITH THE CIOS SPIN AND WAS ~30MM OFF FROM THE TARGET BUT THE CASE WAS COMPLETED SUCCESSFULLY. A PNEUMOTHORAX WAS DISCOVERED POST-OP AND THE PATIENT WAS NOT ADMITTED BUT A CHEST TUBE WAS PLACED. CHEST TUBE WAS REMOVED SAME DAY AND THE PATIENT WENT HOME SAME DAY. THERE WERE NO FAULTS OR ISSUES REPORTED WITH THE MONARCH SYSTEM AND THE PHYSICIAN IS NOT ATTRIBUTING THE EVENT TO THE MONARCH.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE MERGE OF L4-5 LEVELS FOR SINGLE POSITION LATERAL SURGERY SHOWED A SHIFT. WE TOOK NEW SHOTS OF EACH INDIVIDUAL LEVEL AND ADDED L3 AND S1 TO HELP WITH THE MERGE. THE SURGEON WAS UNHAPPY WITH THE MERGE AS THERE WAS SLIGHT MOVEMENT VISIBLE ON THE L4 AND L5 A/P AND LATERAL VIEWS. THE SINGLE POSITION LATERAL CASE WAS ABORTED AND CONVERTED TO AN OPEN PRONE TLIF. PLEASE NOTE THE BED WAS ADJUSTED TO HELP ACCOMMODATE THE ILIAC CREST PRIOR TO ROBOTIC X RAYS BEING TAKEN.

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHEN VERIFYING THE CUTS ON THE FEMUR, IT APPEARED THAT THE LATERAL POSTERIOR CUT HAD BEEN OVER RESECTED BY 1MM WHEN USING VELYS. WHEN SURGEON PUT TRIALS ON, HE NOTICED CONSIDERABLE 1-2MM GAPS BETWEEN BONE AND TRIAL FEMUR FOR THE: POSTERIOR, ANTERIOR, ANTERIOR CHAMFER AND DISTAL. LEFT TKR USING VELYS ATTUNE PS FB CONSTRUCT.

ExcelsiusGPS — 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 REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM DUE TO ADVERSE PATIENT EFFECTS (FOOTDROP).

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN ASSEMBLING THE A/O DRIVER AND ELECTRODE CLAMP GUIDE TUBE, IT WAS NOTED THAT THE SURGEON WAS ABLE TO SPIN THE E.C GUIDE TUBE. HOWEVER, THE E.C. GT APPEARED TO BE ASSEMBLED AS EXPECTED.

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO THE ROBOT BECOMING UNRESPONSIVE, AND SCREWS WERE THEN PLACED WITHOUT ROBOT.

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT DOES NOT RECOGNIZE WHEN THE POWER CORD IS PLUGGED IN. WORKED FINE FOR A CASE LAST NIGHT, BUT WHEN TURNING ON TODAY TO DO A CASE IT WOULD NOT CHARGE THE BATTERY AND WAS RUNNING SOLELY OFF THE BATTERY WHEN TURNED ON. THINK A FUSE IS BLOWN IN THE ROBOT.

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT IS DISPLAYING A BLACK SCREEN WITH WHITE LETTERS ON BOOT UP SAYING "REBOOT AND SELECT PROPER BOOT DEVICE OR INSERT BOOT MEDIA IN SELECTED BOOT DEVICE AND PRESS A KEY".

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: (B)(6), LLIF L2-5 (FLUOROSCOPY WORKFLOW), PLDF L2-ILIUM (PREOP/INTRAOP WORKFLOW). FOR LLIF PORTION OF PROCEDURE FLUOROSCOPY WORKFLOW USED. L3/4 AND L4/5 REGISTERED AND L4/5 INSTRUMENTED FIRST. SURGEON STATED CAGE ENDED UP MORE POSTERIOR THAN PLANNED. L2/3 AND L3/4 REGISTERED AGAIN AND AGAIN, SURGEON STATED CAGE WAS PLACED MORE POSTERIORLY THAN NAVIGATION STATED. SURGEON DECLINED TO REGISTER L2/3 AGAIN AND CAGE PLACED. IN THE END, SURGEON STATED ALL CAGES WERE PLACED MORE POSTERIORLY THAN HE EXPECTED BASED ON THE NAVIGATION SHOWING HIM PLACING CAGES ANTERIOR TO FINAL POSITION.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT BROUGHT INTO ROOM AND TURNED ON WITHOUT ANY ISSUES. SCREEN WENT TO A BLUE SCREEN WITH MESSAGE "A START UP ERROR HAS OCCURRED". TRIED MULTIPLE RESTARTS AND ERROR STILL OCCURRED. CASE HAD TO BE ABORTED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A DBS PROCEDURE AN IDENTICAL BILATERAL DEVIATION WAS NOTICED EVEN WITH 3 REGISTRATIONS. THE PATIENT HAD A BONE FIDUCIAL PLACED AND AN INITIAL NON-STERILE REGISTRATION WITH O ARM SET TO THE STEREOTAXY SETTINGS WAS PERFORMED AND ACCURACY CHECKS WERE PERFORMED. IT WAS NOTICED THAT THE INITIAL REGISTRATION FIT WAS NOT CENTERED ON ALL SPHERES AND REQUIRED A FAIR AMOUNT OF MANIPULATION TO GET INTO A GREEN FIT. ACCURACY CHECKS WERE PERFORMED, INCLUDING WITH THE BONE FIDUCIAL AND SHOWED AN ACCEPTABLE REGISTRATION. THE PATIENT WAS DRAPED AND ACCURACY CHECKS WERE PERFORMED AGAIN SHOWING NO CHANGE IN ACCURACY. THE BURR HOLES WERE CREATED AT WHICH POINT THE PATIENT COUGHED. I ADVISED TO PERFORM ADDITIONAL ACCURACY CHECKS TO THE BONE FIDUCIAL SHOWING A 2-3 MM SHIFT POSTERIOR. A STERILE ICT AND ARM WERE ATTACHED AND ANOTHER O ARM SCAN WITH THE SAME SETTING WAS PERFORMED. THERE WAS A SIMILAR REGISTRATION FIT WITH THIS REGISTRATION AS WELL. ACCURACY CHECKS WERE PERFORMED AND THE LEAD WAS PERFORMED ON THE RIGHT SIDE. AN EVALUATION SCAN WAS PERFORMED SHOWING A 3 MM POSTERIOR MEDIAL DEVIATION. THE LEAD WAS LEFT DUE TO RESPONSIVE TESTING. THE PATIENT COUGHED AGAIN AND ANOTHER REGISTRATION WAS P