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 THE ROBOT WAS SLIDING DURING CASE. SUBSEQUENTLY THE CASE HAD TO BE CANCELLED AND THE PATIENT WAS ALREADY UNDER ANESTHESIA AND INCISION MADE. THE PATIENT HAD TO GO BACK UNDER ANESTHESIA FOUR DAYS LATER, WHEN THE CASE WAS COMPLETED. THE SURGEON DID REPORT BACK TO THE REP THREE DAYS AFTER THE COMPLETED CASE THAT THE PATIENT WAS DOING WELL. NO FURTHER INFORMATION KNOWN.

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 AND SCREWS WERE THEN PLACED BY HAND DURING SURGERY.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS WAS A CRANIAL DBS PROCEDURE ON GMED 4.0. USER PLACED DBS ELECTRODE WITH TOP TO TARGET SET AT 192MM. THE LEAD WAS TOO SHALLOW AND BASED OFF MICRO-ELECTRODE RECORDINGS. THE LEAD WAS REPLACED W/ THE TOP TO TARGET AT THE CORRECT DEPTH. NO FURTHER ISSUES ENCOUNTERED AND CASE WAS COMPLETED AS NORMAL.

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.

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. THIS EVENT OCCURRED IN GERMANY.

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 AND SCREWS WERE THEN PLACED BY HAND DURING SURGERY.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEON REPORTED AN INJURY TO THE POPLITEUS TENDON AFTER OSTEOTOMY WITH MAKO. THE TIMING OF THE INJURY IS UNKNOWN.

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. THE REST OF THE SURGERY WAS PERFORMED FREEHAND.

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 HEMICOLECTOMY PROCEDURE, THE PATIENT REQUIRED A SUBSEQUENT PROCEDURE DUE TO BLEEDING. THE SURGEON INITIALLY UTILIZED THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WITH AN E-100 GENERATOR. IT WAS REPORTED THAT THE E-100 GENERATOR KEPT FAULTING WITH A MESSAGE TO CHECK THE CABLE CONNECTIONS. THE CUSTOMER ALSO REPORTED BLEEDING DUE TO INTERMITTENT ENERGY FROM THE E-100 GENERATOR. THE CUSTOMER CHANGED OUT THE VSE INSTRUMENT AND POWER CYCLED THE E-100 GENERATOR BUT THE ISSUE WAS NOT RESOLVED. THE CUSTOMER THEN SWITCHED TO AN ERBE GENERATOR FOR THE REMAINDER OF THE PROCEDURE, SPECIFICALLY ON VESSELS WITHIN THE MESENTERY AND ALONG THE ILEUM. IT WAS NOTED THROUGHOUT THE PROCEDURE, THE VSE INSTRUMENT MADE THE PROPER SEALING TONES AND NO ERROR MESSAGES WERE PRODUCED. HOWEVER, THE SURGEON STATED THE SEALING TIME TOOK LONGER THAN NORMAL ON MOST SEALING ATTEMPTS. ONCE THE SEALING WAS COMPLETE, THE VESSELS LOOKED FULLY SEALED AND NO ADDITIONAL BLEEDING OCCURRED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO COMPLICATIONS AND THE PATIENT WAS NOTED TO BE "DRY." WITHIN FIFTEEN MINUTES IN THE POST ANESTHESIA CARE UNIT (PACU) THE PATIENT BECAME HYPOT

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 SUBTOTAL GASTRECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT EXHIBITED AN ENERGY OUTPUT ISSUE. THE CUSTOMER REPORTED THAT A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED USING A PROGRASP FORCEPS INSTRUMENT DURING THE SAME PROCEDURE. THE CUSTOMER VISUALLY CONFIRMED THE BROKEN PART MATCHING THE INSTRUMENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETENTION OF FOREIGN MATERIAL.

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 THAT AN INSTRUMENT BROKE IN THE PATIENT. THE CUSTOMER INQUIRED IF THE WIRES AND SHAFT OF THE INSTRUMENT COULD BE DETECTED BY X-RAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. DESPITE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL DETAILS, THE SPECIFIC TYPE OF INSTRUMENT THAT WAS USED REMAINS UNKNOWN.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NILSSEN, P. K., NARENDRAN, N., SKAGGS, D. L., TUCHMAN, A., WALKER, C. T., & PERRY, T. G. (2024). COMPARISON OF ROSTRAL FACET JOINT VIOLATIONS IN ROBOTIC- AND NAVIGATION-ASSISTED PEDICLE SCREW PLACEMENT FOR ADULT LUMBAR SPINE INSTRUMENTATION. THE SPINE JOURNAL. HTTPS://DOI.ORG/10.1016/J.SPINEE.2024.07.008 SUMMARY: BACKGROUND CONTEXT: FACET JOINT VIOLATION BY PEDICLE SCREWS MAY LEAD TO ADJACENT-SEGMENT DISEASE AND POSTOPERATIVE PAIN. PREVIOUS STUDIES HAVE REPORTED THE INCIDENCE OF ROSTRAL FACET JOINT VIOLATION USING VARIOUS PEDICLE SCREW INSERTION TECHNIQUES. HOWEVER, THE INCIDENCE OF FACET JOINT VIOLATIONS WITH ROBOTIC GUIDANCE HAS NOT BEEN DETERMINED. PURPOSE: TO INVESTIGATE AND COMPARE THE INCIDENCE OF ROSTRAL FACET JOINT VIOLATION BY PEDICLE SCREWS UNDER ROBOTIC GUIDANCE AND COMPUTERIZED TOMOGRAPHY (CT) NAVIGATION GUIDANCE. STUDY DESIGN/SETTING: RETROSPECTIVE MATCHED COHORT. PATIENT SAMPLE: ALL PATIENTS WHO UNDERWENT ROBOTIC-ASSISTED LUMBAR FUSION AT A MAJOR SPINE CENTER UP UNTIL 2023 WERE RETROSPECTIVELY IDENTIFIED AND MATCHED 1:3 TO PATIENTS UNDERGOING CT NAVIGATION GUIDANCE BASED BY ON AGE, SEX, ROSTRAL VERTEBRAL LEVEL, AND LENGTH OF CONSTRUCT. INCLUSION CRITERIA CONSISTED OF

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 AND SCREWS WERE THEN PLACED BY 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT FELL OFF INSIDE THE PATIENT. THE MCS INSTRUMENT HAD REPORTEDLY BECOME STUCK AT A RIGHT ANGLE. 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 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 INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE ISI TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT ONE OF THE UNIVERSAL SEAL ACCESSORIES BEING UTILIZED HAD A TRIANGLE PIECE BREAK OFF THE GASKET AND FALL INTO THE PATIENT ANATOMY. THE PERFORMING SURGEON HAPPENED TO NOTICE THE FRAGMENT AND IT WAS SUBSEQUENTLY RETRIEVED AND PULLED OUT. AFTER COMPLETION OF THE PROCEDURE, THE STAFF CHECKED THE SEAL AND DISCOVERED THAT IT HAD A HOLE IN IT. NO FURTHER COMPLICATIONS OR ISSUES WERE NOTED FOLLOWING THE INCIDENT. THE CSR ADVISED THAT THE STAFF WOULD BE INFORMED TO RETAIN THE UNIVERSAL SEAL ACCESSORY FOR FURTHER RETURN AND EVALUATION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORTER SAID THAT THE SEAL WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS NOTED. THE SURGICAL TASK THAT WAS BEING PERFORMED WHEN THE SEAL FRAGMENT FELL INSIDE THE PATIENT WAS INSTRUMENT REMOVAL. IT IS UNKNOWN WHAT CAUSED THE SEAL TO BREAK OR CAUSED THE FRAGME

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 DURING SURGERY; THE ROBOT WAS ABLE TO CALIBRATE THE EMPTY ARM BUT FAILED TO CALIBRATE THE POINTER PROBE. RECALIBRATION EMPTY WAS PERFORMED SUCCESSFULLY AND THEN POINTER PROBE CALIBRATED SUCCESSFULLY. ARM WAS THEN DRIVEN TOWARDS FIDUCIALS. ARM BEGAN TO DRIFT IN FAST MODE WITH NO MANUAL INPUT. FULL POWER DOWN WAS PERFORMED AND ISSUED PERSISTS. PROCEDURE WAS ABORTED AFTER IMPLANTATION OF BONE FIDUCIALS THAT WOULD REQUIRE CLOSURE.

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 AMONG 30 DA VINCI ASSISTED SINGLE PORT NIPPLE SPARING MASTECTOMIES THAT WAS A PART OF A CLINICAL STUDY, 8 PATIENTS WERE FOUND WITH THERMAL BLISTERS NEAR THE MEDIAL BREAST AREA. THE PHYSICIAN STATED THERE'S NO IMPACT ON THE PATIENT OTHER THAN COSMESIS THAT THERE WILL BE SCARS UPON HEALING. THE PROCEDURES WERE COMPLETED AS PLANNED WITHOUT DEVICE MALFUNCTION OCCURRED. THE PHYSICIAN THOUGHT THE CAUSE OF THE BLISTERS MAY BE DUE TO THE TISSUE TENSION APPLIED NEAR THE SKIN DUE TO THE NUMBER OF RETRACTION INSTRUMENTS. THE PHYSICIAN USES TWO INSTRUMENTS FOR RETRACTION IN SINGLE PORT SURGERIES, WHERE SHE USES THREE INSTRUMENTS IN MULTI-PORT SURGERIES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY (RADICAL EXTRAPERITONEAL WITHOUT LYMPHADENECTOMY) SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT A WASHER APPROXIMATELY 5 MILLIMETERS WAS FOUND INSIDE THE PATIENT¿S ANATOMY. THE SURGEON WAS ABLE TO REMOVE THE WASHER FROM THE BODY. THE CUSTOMER STATED THAT THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT WAS INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1, 30-DEGREE ENDOSCOPE WAS INSTALLED ON USM 2, LARGE NEEDLE DRIVER (LND) WAS INSTALLED ON USM 3, AND SYNCHROSEAL INSTRUMENT WAS INSTALLED ON USM 4. THE CUSTOMER REVIEWED THE VIDEO RECORD AND CONFIRMED THAT THE SYNCHROSEAL INSTRUMENT COLLIDED WITH ANOTHER INSTRUMENT CAUSING A WASHER DETACHMENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS REMOVED USING A LAPAROSCOPIC INSTRUMENT. THE CUSTOMER REVIEWED THE VIDEO RECORD AND CONFIRMED THAT ALL FRAGMENT WAS REMOVED, AND ONLY THE WASHER FELL INTO THE PATIENT. NO ADDITIONAL SURGICAL PROCEDURE OR POST-OPERATIVE TEST WAS PERFORMED. THE NU

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 MERGING ISSUE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYNCHROSEAL WASHER CAME LOOSE AND FELL INTO THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

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 ISSUES WITH MERGING.

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 SURGICAL PROCEDURE THE EDGES OF THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS NOT UNIFORM. IT WAS NOT FITTING PROPERLY TO THE MCS INSTRUMENT. THE CUSTOMER STATED THIS IS A DISPOSABLE ACCESSORY AND CANNOT BE RETURNED. THE HOSPITAL HAS DISCARDED THE ACCESSORY. INTUITIVE SURGICAL, INC. FOLLOWED UP WITH THE CUSTOMER AND GATHERED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER ACCESSORY HAD NON-UNIFORM EDGES AS VALIDATED BY THE OPERATING ROOM (OR) TEAM ONCE IT WAS OPEN FROM THE PACK. THE MCS TIP COVER ACCESSORY ALSO DID NOT FIT PROPERLY TO THE MCS, AND THE ORANGE BAND WAS PARTLY VISIBLE. THE TEAM DECIDED TO GO FORWARD WITH THE SAME MCS TIP COVER ASSUMING IT WOULD NOT DETACH FROM THE MCS. HOWEVER, THE SURGEON AND THE OR TEAM WERE QUICK TO VISUALIZE THE IMPROPER ATTACHMENT OF THE MSC TIP COVER ACCESSORY AND CHANGED IT ONCE THE DAMAGE WAS VISUALIZED AND CONFIRMED. THE DAMAGED MCS TIP COVER ACCESSORY DID FALL DURING THE SURGERY, BUT THE SURGICAL TEAM WAS VIGILANT ENOUGH TO IDENTIFY THE IMPROPER ATTACHMENT DUE TO A DEFECT IN THE MCS TIP COVER ACCESSORY. THE MCS TIP COVER ACCESSORY WAS RETRIEVED USING A LAPA

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.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TONG, M., ZHANG, S., ZHANG, W., MOU, L., DONG, Z., WANG, R., LI, S., <(>&<)> HUANG, Y. (2024). EFFICACY AND SAFETY OF NAVIGATION ROB OT-ASSISTED VERSUS CONVENTIONAL OBLIQUE LATERAL LUMBAR INTERBODY FUSION WITH INTERNAL FIXATION IN THE TREATMENT OF LUMBAR DEGENERATIVE DISEASES: A RETROSPECTIVE STUDY. MEDICINE, 103(32). HTTPS://DOI.ORG/10.1097/MD.0000000000039261 SUMMARY: EFFECTIVE INTERNAL FIXATION WITH PEDICLE SCREW IS A KEY FACTOR IN THE SUCCESS OF LUMBAR FUSION WITH INTERNAL FIXATION. WHETHER NAVIGATION ROBOTS CAN IMPROVE THE EFFICACY AND SAFETY OF SCREW PLACEMENT IS CONTROVERSIAL. THIRTY-EIGHT PATIENTS WHO UNDERWENT OBLIQUE LATERAL LUMBAR INTERBODY FUSION INTERNAL FIXATION FROM MARCH 2022 TO MAY 2023 WERE RETROSPECTIVELY ANALYZED, 16 CASES IN THE NAVIGATIONAL ROBOT GROUP AND 22 CASES IN THE FLUOROSCOPY GROUP. USING VISUAL ANALOG SCORE (VAS) FOR THE LOW BACK AND LOWER LIMBS, OSWESTRY DISABILITY INDEX TO COMPARE THE CLINICAL EFFICACY OF THE 2 GROUPS; USING PERIOPERATIVE INDEXES SUCH AS THE DURATION OF SURGERY, INTRAOPERATIVE BLOOD LOSS, INTRAOPERATIVE FLUOROSCOPY TIMES, AND POSTOPERATIVE HOSPITAL STAY TO COMPARE THE SAFETY OF THE 2 GROUPS; AND USING ACCURACY OF PEDICLE SCREWS (APS

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 DURING 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER STATED THAT A PIECE OF SYNCHROSEAL INSTRUMENT BROKE OFF AND HAD FALLEN OFF INTO THE PATIENT. THE PIECE WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL (IS) CONTACTED THE SITE/REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE BY THE NURSE. WHEN REMOVED FROM THE OUTER PACKAGING (BLISTER PACK) THERE WAS NO VISIBLE DAMAGE. THE INSTRUMENT WAS INSERTED AT THE BEGINNING OF THE PROCEDURE. AFTER 2-3 MOVEMENTS AND GRIPPING OF TISSUE, ONE OF THE COVERS OF A FALLOW CAME OFF AND FELL INTO THE PATIENT'S BODY. THE SURGEON THINKS THE REASON FOR THE FRAGMENT FALLING ISSUE IS THAT THE GRASPING OF TISSUE HAD LOOSENED THE TOP PART - NO PARTICULAR MECHANICAL DAMAGE. THE INSTRUMENT WAS IN USE PRIOR TO THE ISSUE FOR 2 TO 3 MINUTES. 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 MATERIALS DURING THE SURGICAL PROCEDURE. THE FRAGMENT FELL INSID

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION WAS RECEIVED. THE AMOUNT OF DEVIATION WAS UNKNOWN BY THE SITE.

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 DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, WHEN DISSECTING THROUGH THE ROUND LIGAMENT ON THE RIGHT SIDE OF THE UTERUS THERE WAS AN AUDIBLE SNAP/CRACK OF THE HARMONIC ACE INSTRUMENT. WHEN THE SURGEON PULLED THE INSTRUMENT BACK TO INVESTIGATE, THEY NOTICED THAT THE MOBILE BLADE OF THE INSTRUMENT WAS NO LONGER ATTACHED. THE BLADE WAS LOCATED IN THE PATIENT'S PELVIS, UNDER THE UTERUS AND REMOVED UNDER DIRECT VISION BY THE ASSISTING SURGEON AT BEDSIDE. 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. THE TECHNICIAN THAT RECEIVED THE HARMONIC ONTO THE FIELD DID NOT NOTICE ANY DAMAGE TO THE INSTRUMENT. THE ISSUE WAS IDENTIFIED DURING ROBOTIC-ASSISTED HYSTERECTOMY, WHILE THE SURGEON WAS DISSECTING THE RIGHT SIDE OF THE UTERUS. PER THE SURGEON, THE ISSUE WAS CAUSED DUE TO A MANUFACTURING ERROR. THE REPORTER EXPLAINED TO THE SURGICAL STAFF THAT HARMONIC DOES NOT HAVE A WRIST. SNAPPING THE WORKING JAW OF THE HARMONIC BY APPLYING TOO MUCH PRESSURE WHILE TRYING TO TWIST THE INSTRUMENT AT THE SAME TIME WILL RESUL

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 A VERIFICATION ISSUE.

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 SURGICAL PROCEDURE, THE CUSTOMER CALLED AN ISI TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED AN ISSUE WITH THE RIGHT MANIPULATOR. TSE VIEWED THE SYSTEM EVENT LOGS AND NOTICED AN ERROR 23025 POINTING AXIS 3. TSE ASKED HIM TO SHUTDOWN THE SYSTEM AND CYCLE THE SSC BREAKER. AFTER RESTARTING THE ERROR REMAINED. CALLER STATED THAT BEFORE CALLING US THEY HAVE TRIED TO RESTART WITHOUT ANY SUCCESS. TSE EXPLAINED THAT THE RIGHT MANIPULATOR WAS DOWN, AND THE SYSTEM WAS NOT USABLE ANYMORE. SURGEON DECIDED TO CONVERT TO OPEN SURGERY WITH NO REPORTED INJURY. ON JULY 19TH, 2024, INTUITIVE SURGICAL (IS) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE SURGERY WAS CONVERTED TO OPEN SURGERY. THE CONVERSION RESULTED IN AN INCREASED PORT SIZE INCISION, SPECIFICALLY A MEDIAN SCAR OF AT LEAST 10 CM. THE PATIENT DID TOLERATE THE CHANGE. HOWEVER, IT IS IMPORTANT TO NOTE THAT POSTOPERATIVE FOLLOW-UP AND FUNCTIONAL RESULTS MAY BE COMPROMISED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT IS NOT ADVANCING PAST THE WHITE "EXCELSIUS" START UP SCREEN.

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 BRANCH BROKE OFF WHILE PREPARING TISSUE FOR NO APPARENT REASON. A FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DEVICE WAS CHECKED BEFORE USE AND THERE WAS NO DAMAGE OR ANYTHING UNUSUAL. THE FRONT OF THE DEVICE WAS DAMAGED DURING TISSUE PREPARATION. THE SURGEON BELIEVED THAT THE INSTRUMENT BROKE OR THE FRAGMENT FELL FOR NO APPARENT REASON. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY 1.5 HOURS BEFORE THE PROBLEM OCCURRED. THE SURGEON DID NOT NOTICE ANY PROBLEMS WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH OTHER INSTRUMENTS OR HARD MATERIALS DURING THE SURGICAL PROCEDURE. NO FRAGMENTS FELL INTO THE PATIENT DURING A COLLISION BETWEEN THE INSTRUMENT TIP AND ACCESSORIES. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (BEFORE THE FRACTURE). AFTER THE FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS EXTENDED. NO RESISTANCE WAS FELT WHEN REMOVING THE INSTRUMENT THROUGH THE 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: A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A DA VINCI ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE. ON POST-OPERATIVE DAY 10, YELLOW LIQUID WITH OBVIOUS ODOR WAS DRAWN FROM THE PRESACRAL DRAINAGE CROWN AND AN ANASTOMOTIC LEAKAGE WAS SUSPECTED BUT NOT CONFIRMED. THE PATIENT UNDERWENT A TREATMENT MODALITY OF NEGATIVE PRESSURE IRRIGATION WHICH RESOLVED THE EVENT. THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY 18 AND THERE WERE NO ADVERSE EVENTS AT THE 30-DAY FOLLOW-UP.

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 SURGICAL PROCEDURE, A RUBBER PIECE OF THE 8-12 MM UNIVERSAL SEAL BROKE OFF AND FELL INTO THE PATIENT. THE CUSTOMER STATED THAT THEY WERE ABLE TO REMOVE THE FRAGMENT AND CONTINUE THE PROCEDURE WITHOUT FURTHER ISSUES. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED AND THERE WAS NOTHING FOUND OUT OF THE ORDINARY. THE CUSTOMER STATED THAT THE FRAGMENT WAS RETRIEVED WITH A GRASPER INSTRUMENT. THE SURGEON SAW THE FRAGMENT FALL AND CONFIRMED THERE WAS ONLY ONE. THE PROCEDURE WAS COMPLETED ROBOTICALLY, THERE WERE NO POST OPERATIVE TESTS, AND THE CUSTOMER IS NOT AWARE OF A REPORT INDICATING THE PATIENT RETURNED DUE TO 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 A PATIENT ENROLLED IN A STUDY, UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE. APPROXIMATELY THREE WEEKS LATER, HOME HEALTH VISIT NOTES INDICATE THAT DRAINS WERE REMOVED ON THE PRIOR DAY AND THAT THE PATIENT STATED FEELING PRESSURE ON THE BREAST THE NEXT DAY. THE FOLLOWING DAY, A NURSE CALL NOTED THAT THE PATIENT REPORTED THE RIGHT BREAST FELT HARDER THAN THE OTHER. A CALL WAS THEN PLACED TO THE PLASTICS NURSE PRACTITIONER (NP) WITH THE PATIENT STATING THE RIGHT BREAST FELT ENGORGED. THE PATIENT SENT PICTURES, AND THE NP DETERMINED VISUALLY THERE WERE NO ISSUES AND TO CONTINUE TO MONITOR. FOUR DAYS LATER, THE PATIENT VISITED WITH PLASTICS AND MILD ERYTHEMA TO THE RIGHT BREAST WITH A SMALL PALPABLE FLUID COLLECTION WAS OBSERVED. FIFTEEN CCS OF SEROSANGUINOUS FLUID WERE REMOVED FROM THE RIGHT BREAST AND SENT FOR CULTURE. BACTRIM WAS PRESCRIBED PROPHYLACTICALLY. SURGERY FOR EXPANDER REPLACEMENT WAS SCHEDULED AS THE INVESTIGATOR STATED THAT SHE DIDN'T WANT THE SEROMA TO GET WORSE OR BECOME INFECTED. THE TISSUE EXPANDER REPLACEMENT SURGERY OCCURRED AS PLANNED AND THE PATIENT WAS EXPANDED TO THE SIZE SHE WANTED, ELIMINATING THE NEED FOR AN

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 ISSUES WITH SCREW TRAJECTORY.

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 SCREWS USING THE EXCELSUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED. THIS EVENT OCCURRED IN ITALY.

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 EXCELSUS 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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND DURING 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT BROKE WHEN THE SURGEON WAS REMOVING THE LIVER PARENCHYMA. A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT AND IT WAS RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER USED A BACKUP HARMONIC ACE INSTRUMENT TO CONTINUE WITH THE PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR OTHER HARD MATERIAL DURING THE PROCEDURE. THE CUSTOMER REMOVED THE FRAGMENT WITH ENDOSCOPIC INSTRUMENTS. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED BY THE ASSISTANT AND THE NURSE. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TEST WAS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE FRAGMENT WAS DISCARDED WHEN THE INSTRUMENT WAS STERILIZED.

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 AND SCREWS WERE THEN PLACED BY HAND DURING SURGERY.

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: A LITERATURE ARTICLE THAT DESCRIBED A RETROSPECTIVE COHORT STUDY OF 146 PATIENTS WHO UNDERWENT ROBOTIC ASSISTED PANCREATICODUODENECTOMY (RPD) FROM 2014 TO 2021 IN A HIGH-VOLUME CENTER WAS ANALYZED. MAJOR COMPLICATIONS (CLAVIEN-DINDO GRADE GREATER THAN 2) OCCURRED IN 41 PATIENTS (28 PERCENT), WHICH INCLUDED BILIARY FISTULA, CLINICALLY RELEVANT POSTOPERATIVE PANCREATIC FISTULA (CR-POPF), GASTROJEJUNOSTOMY FISTULA, INFECTION, DELAYED GASTRIC EMPTYING (DGE), AND POST PANCREATECTOMY HEMORRHAGE (PPH). AMONG THE PATIENTS THAT EXPERIENCED POST-OPERATIVE COMPLICATIONS, 23 PATIENTS REQUIRED RE-OPERATION. THE DESIGNATED AUTHOR WAS CONTACTED AND CONFIRMED THAT THERE WERE NO DA VINCI DEVICE MALFUNCTIONS IN THE PROCEDURES, NOR DID ANY ISI PRODUCTS CAUSE OR CONTRIBUTE TO THE EVENTS.

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.