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: 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 THYMECTOMY PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. THE INSTRUMENT BROKE WHILE THE SURGEON WAS DISSECTING. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE, WHICH WAS VISUALLY CONFIRMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY, USING A BACKUP HARMONIC ACE INSTRUMENT. NO ADDITIONAL SURGICAL PROCEDURE OR POST-OPERATIVE TESTS WERE PERFORMED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO A RETAINED FOREIGN OBJECT.

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 AT THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, WITH THE PATIENT ON THE TABLE, THE MONOPOLAR ENERGY WAS NOT WORKING. TECHNICAL SUPPORT WAS CONTACTED, BUT THE ISSUE WAS NOT RESOLVED OVER THE PHONE. THE SURGEON ELECTED TO ABORT THE PROCEDURE DUE TO THE LACK OF MONOPOLAR ENERGY.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PAI, M., SRINIVASA, V., THIRUGNANAM, B., SONI, A., KASHYAP, A., VIDYADHARA, A., RAO, S. K. (2025). ROBOTIC-ASSISTED CERVICAL PEDICLE SCREW FIXATION WITH CUSTOM INSTRUMENTS. CLINICAL SPINE SURGERY. HTTPS://DOI.ORG/10.1097/BSD.0000000000001841 STUDY DESIGN: PROSPECTIVE STUDY OBJECTIVE: THIS STUDY AIMS TO DESCRIBE A WORKFLOW AND CUSTOM INSTRUMENTS FOR ROBOTIC-ASSISTED CERVICAL PEDICLE SCREW PLACEMENT USING THE MAZORX STEALTH EDITION. SUMMARY OF BACKGROUND DATA: POSTERIOR CERVICAL SPINAL INSTRUMENTATION USING PEDICLE SCREWS OFFERS BIOMECHANICAL ADVANTAGES BUT CARRIES RISKS OF INJURY TO THE VERTEBRAL ARTERY AND NERVE ROOTS. FLUOROSCOPIC AND NAVIGATION AIDS EXIST, YET ROBOTIC ASSISTANCE FOR CERVICAL PEDICLE SCREW PLACEMENT LACKS A DEFINED WORKFLOW. WHILE PREVIOUS GENERATIONS OF SPINE ROBOTS HAVE BEEN USED IN PLACING PEDICLE SCREWS, THERE ARE NO PAPERS IN LITERATURE THAT DESCRIBED THE USE OF THIRD-GENERATION SPINE ROBOTS IN PLACING THEM. METHODS: TWENTY-TWO PATIENTS UNDERGOING CERVICAL PEDICLE SCREW PLACEMENT WITH CUSTOM INSTRUMENTS AND ROBOTIC ASSISTANCE WERE INCLUDED. SCREW TRAJECTORIES WERE PLANNED AND EXECUTED BY THE ROBOTIC ARM, WITH POSTOPERATIVE O-ARM SCANS ASSESSING ACCURACY. CLIN

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: BURN OCCURRED TO SMALL AREA OF TISSUE NEXT TO ONE OF THE METAL ROBOT TROCARS. BURN OCCURRED 2 INCHES UP THE INSTRUMENT SHAFT.

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 RIGHT L4 SCREW WAS ENTERED MEDIALLY, BREACHING THE CANAL. THIS WAS DISCOVERED AFTER A CONFIRMATION SPIN WITH A POST-OPERATIVE COMPUTED TOMOGRAPHY. THE CASE REQUIRED REVISION SURGERY, WHICH WAS PLANNED FOR THE FOLLOWING DAY. THE PATIENT WAS NOTED TO BE AFFECTED. THERE WAS NO SURGICAL DELAY TIME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED NO SYMPTOMS RELATED TO THE SCREW CANAL BREACH AND THE DEVIATION APPEARED TO BE ABOUT 10 MILLIMETERS (MM).

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 SURGICAL PROCEDURE, THE CUSTOMER WAS INSERTING A ROBOTIC CLIP APPLIER AND WHEN THE CLIP APPLIER WENT THROUGH THE CANNULA SEAL, A PIECE OF THE BLACK PLASTIC THAT WAS INSIDE FELL INTO THE PATIENT'S ABDOMEN. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT AND INSPECTED PRIOR TO USE AND NO DAMAGES WERE NOTED; HOWEVER, THE INTERIOR OF THE CANNULA SEAL WAS NOT. THE TASK BEING PERFORMED AT THE TIME OF THE CANNULA SEAL BREAKING WAS AN INSTRUMENT EXCHANGE. IT WAS UNKNOWN WHAT THE SURGEON BELIEVES WAS THE CAUSE OF THE ACCESSORY BREAKING. IT WAS UNKNOWN HOW LONG THE DEVICE WAS IN USE PRIOR TO THE ISSUE. THERE WERE NO ISSUES WITH THE FUNCTIONALITY OF ACCESSORY. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR THE HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE FRAGMENT DID NOT FALL INSIDE OF THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. AN INSTRUMENT WAS REMOVED THROUGH THE CANNULA DURING THE SURGICAL PROCEDURE. THE SURGICAL STAFF DID NOT FEEL ANY RESI

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 IMPLANTS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 WAS SUDDENLY BROKEN, THE FRAGMENT WAS TAKEN OUT. THE PROCEDURE WAS COMPLETED. 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 NOTED. THE SURGICAL TASK BEING PERFORMED AT THE TIME OF THE FRAGMENT FALLING INSIDE THE PATIENT WAS GRASPING TISSUE. THE SURGEON THINKS IT COULD BE THE QUALITY OF THE INSTRUMENT THAT CAUSED THE INSTRUMENT TO BREAK. THE INSTRUMENT WAS IN USE FOR ABOUT HALF AN HOUR. THE SURGEON DID NOTICE THE ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING A SURGICAL PROCEDURE. THE FRAGMENT DID NOT FALL INSIDE OF THE PATIENT DURING THE INSTRUMENT TIP OR ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED DURING THE SURGICAL PROCEDURE PRIOR TO THE BREAKAGE. UPON FINAL REMOVAL OF THE INSTRUMENT THE WRIST WAS STRAIGHTENED, AND NO RESISTANCE WAS NOTICED. THERE WAS NO DAMAGE TO THE CANNULA OR THE INSTRUMENT AFTER THE EVENT OCCURRED. THE

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, HARMONIC ACE INSTRUMENT TIP BROKE INSIDE OF THE PATIENT WHILE GRASPING THE TISSUE. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. 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 NOTED. THE SURGEON WAS RETRACTING TISSUE WHEN THE ISSUE OCCURRED. IT IS UNKNOWN WHAT SURGEONS BELIEVED WAS THE CAUSE OF THE INSTRUMENT BREAKAGE. THE INSTRUMENT WAS IN USE FOR AN HOUR PRIOR TO THE ISSUE. THE SURGEON DID NOT NOTICE ANY ISSUES WERE FUNCTIONALITY OF THE INSTRUMENT DURING THE CASE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE FRAGMENT DID FALL INSIDE OF THE PATIENT DURING AN INSTRUMENT TYPE COLLISION. THE INSTRUMENT WAS REMOVED DURING THE SURGICAL PROCEDURE. THE SURGEON DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. UPON THE FINAL REMOVAL OF THE INSTRUMENT: THE WRIST WAS STRAIGHTENED. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON THE REMOVAL OF THE 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 SURGICAL PROCEDURE, HARMONIC ACE INSTRUMENT STOPPED WORKING. THE CUSTOMER REPLACED THE INSTRUMENT. A FRAGMENT FELL INTO A PATIENT BUT WAS RETRIEVED DURING THE SAME PROCEDURE. X-RAY WAS PERFORMED. THE PROCEDURE WAS COMPLETED. 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 NOTED. IT IS UNKNOWN WHAT SURGEONS BELIEVED WAS THE CAUSE OF THE INSTRUMENT BREAKAGE. THE INSTRUMENT WAS IN USE FOR TWO HOURS PRIOR TO THE ISSUE. THE SURGEON DID NOT NOTICE ANY ISSUES WERE FUNCTIONALITY OF THE INSTRUMENT DURING THE CASE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE FRAGMENT DID NOT FALL INSIDE OF THE PATIENT DURING AN INSTRUMENT TYPE COLLISION. THE INSTRUMENT WAS REMOVED DURING THE SURGICAL PROCEDURE. THE SURGEON DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. UPON THE FINAL REMOVAL OF THE INSTRUMENT: THE WRIST WAS STRAIGHTENED. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON THE REMOVAL OF THE INSTRUMENT, DID NOT

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.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING WAS REPORTED "ARM WOULD NOT ALIGN TO CORRECT CUTTING PLAN FOR PLANAR WORKFLOW. WENT THROUGH ENTIRE TROUBLESHOOTING ALGORITHM AND WAS NOT ABLE TO CORRECT. SURGEON CLOSED PATIENT UP AND WAS UNABLE TO COMPLETE CASE USING MAKO. CASE TYPE / APPLICATION: PKA 3.0".

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) TIP COVER ACCESSORY FELL INSIDE OF THE PATIENT. THE MCS TIP COVER ACCESSORY SLID DOWN THE INSTRUMENT COVERING BOTH BLADES. WHEN TRYING TO REMOVE THE SCISSORS TO REPLACE, THE MCS TIP COVER ACCESSORY, IT CAME OFF THE INSTRUMENT AND FELL INTO THE PATIENT. IT WAS RETRIEVED WHEN THE SURGEON CONVERTED TO OPEN SURGERY (AS WAS THE INTENTION FOR THIS PATIENT). INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTURMENT WAS INSPECTED AND NO DAMAGE OBSERVED. THE FRAGMENT WAS RETRIEVED. THE PROCEDURE WAS CONVERTED TO OPEN (AS PLANNED AT BEGINNING) WHEN INSPECTING 8MM CANNULA UPON REMOVAL FROM PATIENT, MSC TIP COVER ACCESSORY WAS RETRIEVED FROM WITHIN THE CANNULA. TIP COVER OBSERVED TO HAVE SLIPPED AT END OFF THE SCISSORS DURING DISSECTION AND CAME OFF INSTRUMENT DURING REMOVAL. THE SURGEON BELIEVED THAT AN INCORRECT PORT PLACEMENT LEADING TO INSTRUMENT-TO-INSTRUMENT COLLISIONS WAS THE ISSUE OF THE FRAGMENT FALLING INTO THE PATIENT. THE INSTRUMENT WAS IN USE FOR 100% OF THE PROCEDURE. THE MCS INSTRUMENT COLLIDED WITH C

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 SURGICAL PROCEDURE THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT WAS LOOSE AND FELL OFF INSIDE THE PATIENT. THE MCS TIP COVER ACCESSORY 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: REFER TO H11 FOR FOLLOW-UP INFORMATION.

Poolrunner Battery Pro Performance — Fully automatic battery-operated pool robot for cleaning pools, powered by a rechargeable battery. Product sold online, in particular via steinbach-group.com. Hazard (Burns, Fire): A technical defect in the charging station or the battery could cause a fire and burns to the user. The product does not comply with the Low Voltage Directive. Action: Recall of the product from end users.

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 SYNCHROSEAL INSTRUMENT WAS BEING USED ON THE UTERINE VESSELS AND DID NOT FULLY SEAL. THE INSTRUMENT THEN EMITTED A SPARK. WHEN THE SURGEON ATTEMPTED TO ADDRESS THE BLEEDING, THE E-100 GENERATOR COMPLETELY SHUT OFF. THE SITE THEN PERFORMED A HARD RESET OF THE GENERATOR. THE GENERATOR DID COME BACK ON, BUT THE SURGEON CHOSE TO REMOVE THE SYNCHROSEAL INSTRUMENT FROM USE. MINIMAL BLEEDING OCCURRED DURING THIS TIME. NO REPAIR WAS NEEDED. NO COLLISIONS WITH OTHER INSTRUMENTS WERE REPORTED. NO PHOTOS OR VIDEOS ARE AVAILABLE FOR REVIEW. 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 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 RADICAL W/LYMPHADENECTOMY PROSTATECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY SLIPPED OFF FROM THE SCISSORS AND FELL INTO THE PATIENT; THE GREY PART OF THE SCISSOR WAS DAMAGED AND COULD APPRECIATE THE ORANGE PART. THE MCS TIP COVER ACCESSORY WAS INSPECTED PRIOR TO USE AND NO DAMAGED WAS NOTICED. THE MCS TIP COVER ACCESSORY WAS RETRIEVED BY THE FIRST ASSISTANT WITH A LAPAROSCOPIC INSTRUMENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS DURING THE PROCEDURE AND THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED. NO INFORMATION OF THE SURGICAL TASK WAS AVAILABLE, AND THE SURGEON DID NOT KNOW THE CAUSE OF THE ISSUE. THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE AND NO ORANGE SURFACE WAS VISIBLE AFTER BEING INSTALLED. THE INSTALLATION TOOL WAS USED, NO LUBRICANT WAS APPLIED PRIOR TO INSTALLATION, AND THE REDUCER WAS NOT USED. THERE WAS NO DIFFICULTY WHEN REMOVING THE MCS AND THE TIP COVER. THE MCS WRIST WAS STRAIGHTENED UPON REMOVAL. SURGICAL STAFF NOTICED A SMALL ORANGE MARK WHERE THE TIP COVER WAS PLACED. THE MCS TIP COVER ACCESSORY IS NOT AVAILA

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WAN, J. J., YEO, J., CHEW, Z., & DINESH, S. K. (2025). COMPARATIVE COST-EFFECTIVENESS ANALYSIS BETWEEN NAVIGATED ROBOT-ASSISTED PLATFORMS AND O-ARM NAVIGATION IN MINIMALLY INVASIVE TRANSFORAMINAL INTERBODY FUSION (MIS-TLIF). THE SPINE JOURNAL. HTTPS://DOI.OR G/10.1016/J.SPINEE.2025.05.027 SUMMARY: BACKGROUND CONTEXT: MINIMAL INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION(TLIF) IS AN INCREASINGLY COMMON PROCEDURE USED IN TREATING DEGENERATIVE LUMBAR SPINE CONDITIONS. ADVANCEMENT OF ROBOT-ASSISTED TECHNOLOGY HAS IMPROVED ACCURACY OF INSTRUMENTATION WITH SMALLER INCISIONS, RESULTING IN BETTER SURGICAL OUTCOMES AND SHORTER HOSPITAL STAY. PURPOSE: THIS STUDY AIMS TO ASSESS COST EFFECTIVENESS OF ROBOT-ASSISTED MINIMALLY INVASIVE TLIF(RA-TLIF) IN OUR INSTITUTION; AND COMPARE PATIENT OUTCOMES WITH CONVENTIONAL O-ARM NAVIGATED MINIMALLY INVASIVE TLIF (ON-TLIF). DESIGN: SINGLE-CENTER, RETROSPECTIVE CASE COHORT SERIES BETWEEN ELECTIVE RA-TLIF AND ON-TLIF GROUPS. PATIENT SAMPLE: ABOUT 27 PATIENTS WHO UNDERWENT ELECTIVE RA-TLIF AND CONTROL GROUP OF 50 ELECTIVE ON-TLIF. OUTCOME MEASURES: OPERATIVE DURATION, LENGTH OF INPATIENT STAY, POSTOPERATIVE AMBULATION, RATES OF INTRAOPERATIVE AND POSTOPER

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 PHYSICIAN ENCOUNTERED NAVIGATION ACCURACY ISSUES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT..

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING MULTIPLE PROCEDURES, THE MONARCH ROBOT NAVIGATION SYSTEM WAS UNSURE WHICH AREA OF THE LUNG IT WAS IN WITH DISTANCE MEASUREMENTS VARYING UP TO 30MM. BIOMED WAS ABLE TO RECREATE PRODUCT ISSUE IN DEMO ENVIRONMENT. PROBLEMS INTERMITTENTLY BEGAN AFTER SOFTWARE UPDATE 5 WEEKS AGO BUT BECAME MORE CONSISTENT LAST WEEK.

ROSA Robotic Surgery — 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 SURGERY, THE ROBOT DISCONNECTED THE ARM AFTER REGISTRATION AND VERIFICATION. SOFTWARE AND THE ROBOT WERE RESTARTED, AND THE ROSA WAS POWERED OFF FOR 3 MINUTES. THE ROSA STILL DIDN´T RECONNECT THE ARM. SURGERY WAS CANCELED WHILE PATIENT WAS UNDER GENERAL ANESTHESIA AND HAD IMPLANTED BONE FIDUCIALS JUST FOR THE CASE. AFTER SERVICE, THE SURGERY WENT WELL AND WITHOUT ISSUES. IT WAS AN EPILEPSY PATIENT, WHERE 8 ELECTRODES WERE INSERTED DURING SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

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 PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 PARTIAL NEPHRECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSOR (MCS) TIP COVER ACCESSORY, INSTALLED ON AN MCS INSTRUMENT, HAD A HOLE. THE MCS INSTRUMENT WAS IN USE WHEN AN ARCING EVENT OCCURRED, INADVERTENTLY BURNING THE PATIENT'S KIDNEY. IT WAS IDENTIFIED THAT THERE WAS A HOLE AT THE SEAM OF THE MCS TIP COVER ACCESSORY. THE BURNED KIDNEY TISSUE WAS EXCISED TO REPAIR THE DEFECT. THE INSTRUMENT'S MCS TIP COVER ACCESSORY WAS REPLACED, AND THE SAME MCS INSTRUMENT WAS USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO COMPLICATIONS.

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 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: IT WAS REPORTED THAT DURING A PLANNED DA VINCI-ASSISTED SP SURGICAL PROCEDURE THE CUSTOMER WAS UNABLE TO GET AN INSTRUMENT TO ENGAGE ON UNIVERSAL SURGICAL MANIPULATOR (USM) #1. SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. PRIOR TO CALLING IN, THE CUSTOMER REBOOTED THE SYSTEM AND REPLACED THE DRAPE WITH NO CHANGE. THE CUSTOMER TRIED MULTIPLE INSTRUMENTS WITH NO CHANGE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) NOTED AN ERROR IN THE LOGS. THE TSE HAD THE CUSTOMER RESEAT THE STERILE ADAPTER SEVERAL TIMES WITH NO CHANGE. THE CUSTOMER CONFIRMED THAT THE DRAPE WAS NOT GETTING CAUGHT. THE TSE HAD THE CUSTOMER PERFORM A HARD REBOOT OF THE SYSTEM WITH NO CHANGE. THE CUSTOMER STATED THAT THE SURGEON WAS UNABLE TO PERFORM THE PROCEDURE WITH JUST 3 ARMS. THE SURGEON DID NOT DISABLE OR DISCONTINUE USE OF THE USM DUE TO THE ISSUE. TO RESOLVE THE ISSUE, CUSTOMER REMOVED THE DA VINCI SP SURGICAL SYSTEM AND WHEELED IN A DA VINCI XI (MULTI-PORT) SURGICAL SYSTEM TO COMPLETE THE CASE. ADDITIONAL PORTS WERE PLACED TO PERFORM THE SURGICAL PROCEDURE. THE PATIENT TOLERATED THE CHANGE. THE PATIENT HAD THE INITIAL S

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 was conducted which reported two patient in the 3D visualization group had postoperative fever. Two patients in the conventional CT group had obvious gross hematuria after 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 of the article was conducted which reported 1 case of severe complications involving postoperative bleeding treated with interventional embolization.

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 HIATAL HERNIA-PARAESOPHAGEAL SURGICAL PROCEDURE, SYNCHROSEAL INSTRUMENT SHAFT BROKE OFF LEAVING THE PIECES INSIDE OF THE PATIENT. THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. 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 VISIBLE DAMAGE WAS NOTED ON THE DEVICE. THE SURGEON BELIEVED THAT THERE WAS A WEAK POINT CAUSING THE MATERIAL TO BREAK APART. THE CUSTOMER DID NOT SEE ANY COLLISIONS WITH OTHER INSTRUMENTS. THE FRAGMENT DID NOT FALL DUE TO A COLLISION. THE INSTRUMENT WAS REMOVED PRIOR TO THE BREAKAGE. THERE WAS NO DAMAGE TO THE CANNULA AFTER THE EVENT. THERE WAS NO OTHER DAMAGE TO THE INSTRUMENT OTHER THAN THE LOCATION OF THE SHAFT THAT CAME OFF. THE FRAGMENT WAS REMOVED BY A LAPAROSCOPIC, ATRAUMATIC GRASPER. ALL FRAGMENTS WERE RETRIEVED AND VISUALIZED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. THERE WERE NO POSTOPERATIVE TESTS, SUCH AS AN X-RAY OR ULTRASOUND OR PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY W

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 PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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, PNEUMO WAS LOST AND A BROKEN PLASTIC RING INSIDE THE SEAL CAP WAS NOTED. THE CLEAR LEAFLET WAS MISSING. IT IS UNKNOWN IF THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: A RAPID LOSS OF INSUFFLATION WAS NOTED, A RAPID LOSS OF PNEMO WAS THE CLUE SOMETHING WAS WRONG. THE CUSTOMER WAS NOT SURE IF THE ACCESSORY WAS INSPECTED PRIOR TO USE. THE CUSTOMER COULD NOT CONFIRM THAT THE OUTER LEAFLET FELL INTO THE PATIENT. THE ACCESSORY WAS IN USE FOR ABOUT AN HOUR. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THEY STILL CAP IS STATIONARY AND WOULD NOT HAVE COLLIDED WITH ANY OTHER CAPS, BUT INSTRUMENTS WERE INTRODUCED THROUGH THE CAP, POSSIBLY SEVERAL TIMES DURING THE CASE. THE CUSTOMER DIDN'T KNOW WHERE THE FRAGMENT WAS. THE FRAGMENT WAS NOT FOUND; HENCE, IT WAS NOT RETRIEVED. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. THERE WERE NO POST OPERATIVE TESTS

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 PANCREATICODUODENECTOMY PROCEDURE, TISSUE WAS ADHERING TO THE HARMONIC ACE INSTRUMENT. A NURSE TOOK OUT THE INSTRUMENT, WIPED THE ADHERED TISSUE AT THE TIP OF THE HARMONIC ACE INSTRUMENT WITH GAUZE, AND THEN RE-INSERTED THE INSTRUMENT. THE CHIEF SURGEON INSPECTED THE HARMONIC ACE INSTRUMENT AND NOTICED THAT THE TIP OF THE INSTRUMENT WAS BROKEN. A BROKEN PIECE FROM THE INSTRUMENT HAD FALLEN INSIDE THE PATIENT BUT WAS REMOVED DURING THE SAME SURGICAL PROCEDURE. A NEW HARMONIC ACE INSTRUMENT WAS USED TO CONTINUE THE PROCEDURE WHICH WAS COMPLETED ROBOTICALLY.

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.

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 PROCEDURE, AN ALARM WAS GENERATED INDICATING THAT THE TIP OF THE HARMONIC ACE INSTRUMENT WAS OVER-STRESSED. THE CUSTOMER REINSTALLED HARMONIC ACE THE INSTRUMENT. DURING THE TASK OF DISSECTING, A FRAGMENT FELL FROM THE INSTRUMENT INSIDE THE PATIENT. THE ASSISTANT REMOVED THE FRAGMENT WITH A LAPAROSCOPIC INSTRUMENT. NO ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE THE INSTRUMENT, NOR WAS ANY IMAGING PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING WAS REPORTED "A PATIENT WHO HAD UNDERGONE MAKO-PKA SURGERY ON (B)(6) COMPLAINED OF PAIN IN THE SURGICAL SITE ABOUT A WEEK LATER. THE PHYSICIAN CONFIRMED BY MRI THAT AN ARTERY ABOUT 1 MM IN DIAMETER ON THE POSTERIOR MEDIAL SIDE HAD SUFFERED VASCULAR DAMAGE LEADING TO AN ANEURYSM. THE PATIENT UNDERWENT ENDOVASCULAR CATHETERIZATION TO TREAT THE ANEURYSM."

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 APPROXIMATELY 2 HOURS INTO A DA VINCI-ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND PELVIC LYMPH NODE DISSECTION PROCEDURE, THE SYSTEM DISPLAYED A "REDUCE BLADE PRESSURE" MESSAGE WHILE THE CUSTOMER WAS USING A HARMONIC ACE INSTRUMENT. THE INSTRUMENT WAS REMOVED, CLEANED, AND REASSEMBLED AT THE BEDSIDE. HOWEVER, AFTER REINSTALLING THE HARMONIC ACE INSTRUMENT ONTO THE UNIVERSAL SURGICAL MANIPULATOR (USM) AND TESTING THE INSTRUMENT, THE BLADE TIP FRACTURED. A FRAGMENT REPORTEDLY FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE SURGEON CHOSE TO REPLACE THE INSTRUMENT WITH A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TO CONTINUE PARA-AORTIC LYMPH NODE DISSECTION AND TO COMPLETE THE PROCEDURE AS PLANNED. NO POSTOPERATIVE IMAGING WAS PERFORMED.

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 NIPPLE SPARING MASTECTOMY PROCEDURE AND WHILE THE SURGEON WAS DISSECTING THE POSTERIOR PLANE OF THE MAMMARY GLAND, THE MONOPOLAR CURVED SCISSORS (MCS) TIP FELL OFF THE MCS INSTRUMENT. THIS HAPPENED DURING MANIPULATION OF THE LATERAL EDGE OF THE GLAND WHICH WAS DONE USING A FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT AND WITH MCS INSTRUMENT'S BLADES CLOSED. THE MCS TIP WAS REMOVED FROM PATIENT DURING THE SAME SURGICAL PROCEDURE AND A NEW MCS INSTRUMENT WAS THEN INSTALLED. THE CASE WAS COMPLETED ROBOTICALLY. OVERALL, THE INCIDENT ADDED AN ESTIMATED 5 MINUTES TO THE OVERALL DURATION OF 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: A review of an article was performed that presented a retrospective review of experiences with robotic total mesorectal excision procedures. The article noted 14 percent of patients developed pelvic sepsis and 7 percent developed an anastomotic leak.The corresponding author was contacted 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: A REVIEW OF A LITERATURE ARTICLE WAS PERFORMED WHICH NOTED THAT DURING A DA VINCI-ASSISTED RIGHT LOWER LOBECTOMY AND LYMPH NODE DISSECTION PROCEDURE, AN 81-YEAR-OLD MALE EXPERIENCED A BRONCHIAL TEAR IN THE LEFT MAIN BRONCHUS WHEN THE BRONCHIAL CUFF OF THE DOUBLE LUMEN TUBE (DLT) WAS MISTAKEN FOR A LYMPH NODE DURING DISSECTION. THIS CAUSED VENTILATION ISSUES, A BRONCHIAL CUFF RUPTURE, AND A SIGNIFICANT ANESTHETIC CIRCUIT LEAK. THE TEAR WAS REPAIRED WITH SUTURES, AND AN ENDOBRONCHIAL BLOCKER RESTORED ONE-LUNG VENTILATION, ALLOWING THE SURGERY TO PROCEED. THE PATIENT WAS SUCCESSFULLY EXTUBATED POST-PROCEDURALLY. POST-OPERATIVELY, THE PATIENT RECOVERED FROM A MILD CHEST INFECTION AND WAS DISCHARGED AFTER EIGHT DAYS. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, AND NO INDICATION THAT INTUITIVE SURGICAL INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. ISI HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED.

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 AIMED TO COMPARE THE SAFETY AND ONCOLOGICAL OUTCOMES OF OPEN (O-RPLND) AND ROBOTIC (R-RPLND) RETROPERITONEAL LYMPH NODE DISSECTION FOR TESTICULAR CANCER WAS PERFORMED. THE STUDY ANALYZED THIRTY-ONE (47.7%) PATIENTS WHO UNDERWENT R-RPLND BETWEEN 2017 AND 2024. A TOTAL OF 2 PATIENTS EXPERIENCED COMPLICATIONS, INCLUDING ONE PATIENT WHO REQUIRED THE OVERSEWING OF THE VENA CAVA INTRAOPERATIVELY (CLAVIEN-DINDO IIIA). NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY INTUITIVE SURGICAL, INC. (ISI) DEVICE. ISI MADE FOLLOW-UP ATTEMPTS 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 MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT FELL OFF INSIDE THE PATIENT'S PERITONEUM AND HAD TO BE RETRIEVED WITH LAPAROSCOPIC FORCEPS.

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: A REVIEW OF AN ARTICLE THAT AIMED TO COMPARE THE SAFETY AND ONCOLOGICAL OUTCOMES OF OPEN (O-RPLND) AND ROBOTIC (R-RPLND) RETROPERITONEAL LYMPH NODE DISSECTION FOR TESTICULAR CANCER WAS PERFORMED. THE STUDY ANALYZED THIRTY-ONE (47.7%) PATIENTS WHO UNDERWENT R-RPLND BETWEEN 2017 AND 2024. A TOTAL OF 2 PATIENTS EXPERIENCED COMPLICATIONS, INCLUDING ONE PATIENT WHO EXPERIENCED AN INTRAOPERATIVE AORTIC LACERATION LEADING TO MAJOR HEMORRHAGE; THIS REQUIRED CONVERSION TO AN OPEN PROCEDURE FOR VASCULAR REPAIR, WHERE THE AORTIC INJURY WAS SURGICALLY CORRECTED (CLAVIEN-DINDO IIIB). 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 SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE. A FRAGMENT 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 AFTER A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION SURGICAL PROCEDURE, A ROUTINE CT SCAN WAS PERFORMED, AND A FRAGMENT WAS FOUND IN THE PATIENT. THE CUSTOMER WAS UNSURE IF A FRAGMENT CAME OF INTUITIVE SURGICAL, INC. (ISI) INSTURMENT OR ACCESSORY. FRAGMENT HAS NOT BEEN RETRIEVED YET. THE CUSTOMER WAS PLANNING NEXT STEPS. THE PROCEDURE WAS COMPLETED.

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 A SPINAL SURGERY, THE PATIENT WOKE UP FEELING SOME LEFT CALF PAIN AND WENT TO URGENT CARE FOR EVALUATION. THE PATIENT UNDERWENT AN ULTRASOUND AND THE PHYSICIAN ALSO MENTIONED DECREASED BREATH SOUNDS IN THE LEFT LUNG. AS A RESULT, THE PATIENT ALSO UNDERWENT A CHEST X-RAY. THE PATIENT WAS ADMITTED TO THE HOSPITAL OVERNIGHT AS THEY WERE DIAGNOSED WITH A PULMONARY EMBOLISM. THE PATIENT WAS PRESCRIBED ANTICOAGULANTS AND BEGAN TO FOLLOW UP WITH THEIR HEMATOLOGIST OUTPATIENT.