ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE EGPS SYSTEM IS NOT WORKING PROPERLY SINCE IT WAS SERVICED ON WEDNESDAY OF THIS WEEK. WE NEED THIS FIXED ASAP. THE ROBOT SEEMED "SLOW". THE SURGEON WOULD STOP ADVANCING THE SCREW BUT THERE WAS A HALF SECOND DELAY ON THE SCREEN. I AM NOT SURE IF IT IS E3D OR EGPS. WE HAD TO ABORT AND USE FLUORO.

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 FLURO 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 BY HAND DURING SURGERY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

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.

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 THE ROSA HUMERAL CLAMP CREATED A HOLE THROUGH THE CORTICAL BONE, AND CAUSED A FRACTURE WHILE IMPLANTING THE STEM. FRACTURE OF THE HUMERUS NEEDED CERCLAGE WIRE AROUND FINAL IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER NONE IS AVAILABLE 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 THERE WAS PATIENT COMPLICATIONS. THE PATIENT HAD SEVERE HYPOXEMIA. THE PHYSICIAN HIT A VESSEL. AFTER REMOVING THE SCOPE THE PATIENT STARTED TO HEMORRHAGE. THE PHYSICIAN STABILIZED THE HEMORRHAGE WITH A MANUAL SCOPE AND COMPLETED THE PROCEDURE SUCCESSFULLY. THE CHEST TUBE WAS PLACED AND PATIENT WAS HOSPITALIZED AND RELEASED.

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.

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 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 POST OP SCANS SHOWS A SCREW ON THE SAGGITAL AND HAD PERFORATED ANTEROLATERALLY ON THE AXIAL. THIS EVENT OCCURRED IN THE UNITED KINGDOM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CAMERA WAS PLUGGED IN UPON CASE SET UP AND RED "CAMERA BUMP" WARNING APPEARED.

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.

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.

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 TIP OF THE REAMER WAS 6MM TOO POSTERIOR COMPARED TO PLAN. THE SURGEON HAD TO GRAFT THE HOLE AND REAMED AGAIN WITH CONVENTIONAL INSTRUMENTATION TO PREPARE THE CENTRAL HOLE. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

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 PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY WHICH HAD TO BE CANCELLED DURING THE PROCEDURE AS THE DISTAL RESECTION RESULTED IN SEVERE VALGUS.ALL LANDMARKS WERE TAKEN CORRECTLY AND NO DRIFTING OCCURRED DURING THE RESECTION. THE BONE HAD TO BE REBUILT WITH WEDGES. THERE WAS A 30 (THIRTY) MINUTE DELAY TO REBUILD THE BONE. THERE IS NO ADDITIONAL 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 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 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 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 CAMERA WAS PLUGGED IN AND THE 'CAMERA BUMP' WARNING APPEARED. THE CASE WAS CANCELLED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PREPARING FOR A CRANIAL CASE, TURN ROBOT ON, AND NOT GETTING PAST THE EXCELSIUS GPS HOME SCREEN. TRIED RESTARTING AND POWER CYCLING, UNPLUGGING FOR MULTIPLE MINUTES. HAVE NOT BEEN ABLE TO GET PAST IT.

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 THE ALL THE USERS PASSWORDS HAD EXPIRED AND THEY WERE UNABLE TO LOGIN TO THE MONARCH SYSTEM. THE PHYSICIAN ELECTED TO ABORT THE CASE AND RESCHEDULED.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A DBS CASE SET UP A CAMERA HARDWARE MALFUNCTION, WARNING DISPLAYED ONCE THE CAMERA WAS PLUGGED IN. THE JAR ALARM INDICATOR LIGHT WAS ALSO ILLUMINATED.

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 POST OP CT SCAN CONFIRMED.

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 POST OP CT SCAN SHOWS MULTIPLE MEDIAL BREACHES.

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, THE CASE WAS ABORTED AND THEN FREE HANDED.

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, WITH SUBSEQUENT DURAL TEAR THAT WAS REPAIRED.

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.

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 WHILE DRIVING IN THE RIGHT UPPER LOB (RUL), AND 25MM OUT FROM THE TARGET, USER DECIDED TO DO A SPIN TO CONFIRM HE WAS IN LINE WITH THE LESION AND GET READY TO PLACE A DYED COIL. THE SPIN WAS DONE AND THE SCOPE WAS OBSERVED TO BE THROUGH THE LUNG AND INTO THE PLEURAE WHILE THE SYSTEM WAS SHOWING THEY WERE 25MM OUT, RESULTING IN A PNEUMOTHORAX.

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 ¿INCORRECT CUTS WERE MADE¿ WHILE USING THE ROBOTIC-ASSISTED SOLUTION SATELLITE STATION DEVICE. ACCORDING TO THE REPORT, THE SURGEON INITIALLY CUT FOR A SIZE 6 FEMUR AND WANTED TO RECUT TO A SIZE 5 FEMUR TO OPEN FLEXION SPACE. THE REPORTER STATED THAT THE ROBOT WAS SET TO ¿ANTERIOR REFERENCING¿, SO THE SURGEON CHANGED TO A SIZE 5 AND RECUT FEMUR. IT WAS REPORTED THAT THE CUTS WERE OFF BY OVER ¿ONE FULL SIZE AND THE CHAMFER CUTS WERE ANGLED WAY OFF.¿ THE REPORTER STATED THAT THE SURGEON DID NOT OBSERVE PIN OR ARRAY MOVEMENT, BUT IT COULD HAVE HAPPENED. THE SURGEON SWITCHED FROM PRESS FIT TO CEMENTED CRS REVISION FEMUR WITH 30MM STEM AND A RP REVISION TIBIA WITH A CONSTRAINED CRS FEMUR DUE TO CUTS NOT MATCHING. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT STARTED WITH 15 DEGREES OF FLEXION CONTRACTURE. AFTER THE INITIAL CUTS, THE PATIENT HYPER EXTENDED BY 15 DEGREES AND WAS ANOTHER REASON TO USE CRS REVISION COMPONENTS. IT WAS REPORTED THAT THERE WAS A SURGICAL DELAY OF 35 MINS. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BE

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE DOCTOR WAS DOING AN INTRA-OP ROBOT CASE AT LEVELS L3-L5. WE PLACED SCREWS ON THE RIGHT SIDE FOLLOWED BY THE LEFT. WE ALSO DID A CHECK WITH THE VERIFICATION PROBE TO ENSURE TRAJECTORY AND CONFIRMATION OF SCREWS. EVERYTHING LOOKED GOOD THUS FAR. AFTER THE PLACEMENT OF SCREWS AND RODS, WE PROCEEDED TO TAKE A 2ND SPIN TO CONFIRM SCREW AND ROD PLACEMENTS. WE THEN DISCOVERED THE SCREW AT L4R HAD SHIFTED A BIT LATERAL OF THE PEDICLE.

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: EGPS PERFORMED A CASE PERFECTLY TODAY THEN WAS POWERED DOWN. 45 MINUTES LATER IT WAS POWERED BACK UP TO LOAD A SCAN BUT WOULD NOT POWER UP. BATTERY LIGHT WAS CYCLING ,YELLOW INFORMATION RING WAS ON, NO SYNC MONITOR WARNING COMES UP BUT NOTHING APPEARED ON THE SCREEN. WE HAVE REBOOTED MULTIPLE TIMES CHANGED POWER SUPPLY POINT MULTIPLE TIME AND FRANCESCO BELIEVES IT TO BE A COMPUTER FAILURE AND THAT THE COMPUTER NEEDS TO BE 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 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 SURGEON USED THE NS INSTRUMENTATION TO MARK PLACEMENT OF THE BURR HOLES. THE PATIENT AND EGPS WERE DRAPED AND THE IGEE WAS VERIFIED BY THE SCRUB TECH. THE EGPS WAS PUSHED IN WITH THE O-ARM STILL IN SCAN POSITION TO ALLOW FOR EVALUATION SHOTS. ONCE THE INCISION/APPROACH WAS COMPLETED, THE ARM WAS BROUGHT IN ALONG THE VIM R TRAJECTORY. AS THE SURGEON PLACED THE CANNULA IN THE CENTRAL TRAJECTORY, THE ENTRY POINT APPEARED TO BE CLOSE TO THE POSTERIOR EDGE OF THE BURR HOLE COVER. AS THE SURGEON INSERTED THE CANNULA, HE BOVIED THE CANNULA WHICH CAUSED THE EGPS SCREEN TO TEMPORARILY BLACK OUT DURING THE BOVIE USAGE WHEN THE CANNULA WAS SEATED, AN O-ARM SPIN WAS PERFORMED TO CHECK CANNULA PLACEMENT. THE CANNULA TRAJECTORY WAS OFF WITH THE ENTRY POINT POSTERIOR AND THE TRAJECTORY POINTING ANTERIOR. THE TIP OF THE CANNULA (PLANNED FOR 10MM ABOVE TARGET) PRESENTED A DEVIATION OF E/ 11.5 AND E/1.4. LANDMARK CHECKS WERE PERFORMED AGAIN AND IT APPEARED THAT THE CENTER OF THE BURR HOLE SHOWED ANTERIOR OF THE PLANNED TRAJECTORY ON THE SCREEN. A STERILE REGISTRATION WAS THEN PERFORMED BUT FOLLOWING THE TRANSFER OF THE SPIN AND CONFIRMATION OF THE FIDUCIALS, THE EGPS PRESENTED AN ERROR STATING T

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 THE MEDICAL CRUCIATE LIGAMENT WAS UNINTENTIONALLY CUT. IT WAS REPORTED THAT REVISION COMPONENTRY WAS REQUIRED. THE LIGAMENT WAS REPAIRED AND IMPLANTED COMPONENTS LOOKED GOOD. IT WAS REPORTED BY THE SURGEON THAT THE RETRACTORS SHOULD HAVE BEEN PLACED BETTER. IT WAS REPORTED THAT THE DEVICE WAS BEING USED WITH A ROBOTIC ASSISTED BASE STATION DEVICE. THERE WERE NO DELAYS IN THE PROCEDURE REPORTED. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

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, THE CASE WAS ABORTED AND THEN FREE HANDED TO PLACE SCREWS.

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 THE SAW BLADE DETACHED FROM SAW HAND PIECE WHILE CUTTING FEMUR, SAW BLADE STAYED EMBEDDED IN THE FEMUR. BLACK LIQUID WAS NOTED AROUND WHERE THE SAW BLADE ATTACHES TO THE SAW HAND PIECE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 5.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED ANONYMOUSLY TO FDA THROUGH A MEDWATCH 3500A FORM THAT A PATIENT EXPERIENCED SERIOUS ADVERSE EFFECTS FOLLOWING SCREW PLACEMENT WITH THE GLOBUS SPINE ROBOT. IT WAS REPORTED THAT THE SCREW(S) WERE NOT PLACED TO PLAN BY THE USER.

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 PRIOR TO A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, THE ROBOTIC-ASSISTED SOLUTION SAW HANDPIECE DEVICE WAS OPENED FOR THE PROCEDURE PRIOR TO THE PATIENT COMING INTO THE ROOM. THE DEVICE HAD A LEAK WHICH APPEARED TO BE OIL. IT WAS REPORTED THAT THE SAME WAS TRUE WITH THE SECOND HANDPIECE. THE HANDPIECES WERE RETURNED TO STERILE PROCESSING FOR CLEANING AND STERILIZATION. WHEN IN STERILE PROCESSING THE DEVICE WAS HAND WASHED AND IT WAS MADE SURE THAT ALL RESIDUE WAS REMOVED FROM BOTH HANDPIECES AND RE-STERILIZED. AFTER THE STERILIZED PACKAGES WERE RE-OPENED, THE OIL RE-APPEARED AND THE CASE HAD TO BE CANCELLED. IT WAS REPORTED THAT THE PATIENT RECEIVED A REGIONAL ANESTHETIC PRIOR TO THE PROCEDURE BEING CANCELLED. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. THIS IS REPORT 2 OF 2 FOR (B)(4).

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TWO LASER FIBERS WERE IMPLANTED DURING THIS PROCEDURE: LEFT HIPPOCAMPUS AND LEFT ANTERIOR. LEFT ANTERIOR HAD A GOOD PLACEMENT THE FIRST TIME, BUT LEFT HIPPOCAMPUS WAS 13.1 MM OFF IN RADIAL ERROR DUE TO SKIVING. THE LASER FIBERS WAS REIMPLANTED UNDER A NEW INTRAOP PLAN, AND HAD A RADIAL ERROR OF 1.8 MM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: E3D SPIN WITH AUTOMATIC REGISTRATION PERFORMED. SCREWS PLANNED, SURGEON MOVED ARM TO TRAJECTORY AND DEPTH OF BURR WAS SHOWING DEEP. SECOND E3D SPIN PERFORMED WITH AUTOMATIC REGISTRATION, SCREWS PLANNED, VERIFICATION PROBE SHOWED GOOD DEPTH. SURGEON PLACED T8-T12 SKIPPING T10 IN A SERPENTINE FASHION STARTING AT LT8. E3D BROUGHT IN FOR XRAY AND LT9 WAS SHOWN TO BE LATERAL OUTSIDE THE PEDICLE WHILE ALL OTHER SCREWS WERE GOOD. VERIFICATION PROBE USED TO CHECK NAVIGATION. NAVIGATION LOOKED INTACT. SURGEON ATTEMPTED TO PLACE LT9 AGAIN AND SCREW WAS AGAIN LATERAL. SURGEON REMOVED SCREW AND PLANNED SCREWS AT T7 BILATERALLY. SURGEON PLACED SCREWS AND LT7 WAS LATERAL, OUTSIDE THE PEDICLE AND RT7 LOOKED GOOD. SURGEON REMOVED LT7, ANOTHER CHECK PERFORMED BUT THIS TIME, BOTH ABOVE AND BELOW THE FRACTURE SITE, NAVIGATION WAS SHOWING LATERAL SHIFT TO THE LEFT. SCAN CONVERTED TO PREOP AND MERGE PERFORMED WITH E3D. MERGE GOOD ON FIRST ATTEMPT. SURGEON PLACED LT7 AND LT9 AND XRAY CONFIRMED GOOD PLACEMENT.

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 PRIOR TO A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, THE ROBOTIC-ASSISTED SOLUTION SAW HANDPIECE DEVICE WAS OPENED FOR THE PROCEDURE PRIOR TO THE PATIENT COMING INTO THE ROOM. THE DEVICE HAD A LEAK WHICH APPEARED TO BE OIL. IT WAS REPORTED THAT THE SAME WAS TRUE WITH THE SECOND HANDPIECE. THE HANDPIECES WERE RETURNED TO STERILE PROCESSING FOR CLEANING AND STERILIZATION. WHEN IN STERILE PROCESSING THE DEVICE WAS HAND WASHED AND IT WAS MADE SURE THAT ALL RESIDUE WAS REMOVED FROM BOTH HANDPIECES AND RE-STERILIZED. AFTER THE STERILIZED PACKAGES WERE RE-OPENED, THE OIL RE-APPEARED AND THE CASE HAD TO BE CANCELLED. IT WAS REPORTED THAT THE PATIENT RECEIVED A REGIONAL ANESTHETIC PRIOR TO THE PROCEDURE BEING CANCELLED. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. THIS IS REPORT 1 OF 2 FOR (B)(4).

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: CAMERA BUMP WARNING AT (B)(6) MEDICAL CENTER NEED IMMEDIATE REPLACEMENT. MULTIPLE CASES ARE SCHEDULED FOR TUESDAY (B)(6) 2025. CURRENTLY ON: GMED 4.0 USING VEGA CAMERA.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE PLACING RIGHT SI1 SCREW THE SURGEON NOTICED RIGHT AWAY THAT SOMETHING WAS OFF AND UPON FLUORO IMAGING THEY REALIZED THAT THE SCREW WAS PLACED MUCH FURTHER CRANIAL THAN PLANNED OR INTENDED. THIS SCREW APPEARS TO HAVE BEEN PLACED IN DIRECTION OF RIGHT L5 TRANSVERSE PROCESS. THE SCREW WAS REMOVED AND WERE ABOUT TO USE E3D TO REREGISTER PATIENT VIA CT SPINE. AT THIS TIME IT WAS BROUGHT TO DR. VASILAKIS' ATTENTION THAT PATIENT WAS SHOWING SIGNS OF CARDIOVASCULAR DISTRESS AND CASE WAS TERMINATED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A CASE IT WAS IDENTIFIED DURING AN X-RAY THAT A SCREW WAS MISSED AT L3-R ON A T10-PELVIS. THE MERGE APPEARED FINE AND THE OTHER SCREW WERE TO PLAN. THE MISPLACED SCREW WAS TAKEN OUT AND THEN PUT BACK IN SUCCESSFULLY USING THE ROBOTIC ARM.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CLINICAL SPECIALIST REPORTED THAT DURING THE PROCEDURE, THE LIVE CAMERA VIEW ON THE SCOPE SUDDENLY BECAME STATIC AND FUZZY, LEADING TO A LOSS OF VIEW. THE USER SWITCHED SCOPES AND SUCCESSFULLY NAVIGATED TO THE LESION. HOWEVER, WHILE BIOPSYING, AN FAULT OCCURRED, INDICATING DISCONNECTION OF THE SCOPE AND DISABLING OF ROBOTIC FUNCTIONS. DESPITE ATTEMPTS, THE USER COULDN'T TURN THE CAMERA BACK ON OR CLEAR THE ERROR. THE CLINICAL SPECIALIST MENTIONED THAT THE ISSUE RECURRED WITH THE SECOND SCOPE DURING BIOPSYING. CONSEQUENTLY, THE PHYSICIAN DECIDED TO END THE PROCEDURE WITHOUT FURTHER BIOPSIES. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SCOPE ISSUES.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CLINICAL SPECIALIST REPORTED THAT DURING THE PROCEDURE, THE LIVE CAMERA VIEW ON THE SCOPE SUDDENLY BECAME STATIC AND FUZZY, LEADING TO A LOSS OF VIEW. THE USER SWITCHED SCOPES AND SUCCESSFULLY NAVIGATED TO THE LESION. HOWEVER, WHILE BIOPSYING, AN FAULT OCCURRED, INDICATING DISCONNECTION OF THE SCOPE AND DISABLING OF ROBOTIC FUNCTIONS. DESPITE ATTEMPTS, THE USER COULDN'T TURN THE CAMERA BACK ON OR CLEAR THE ERROR. THE CLINICAL SPECIALIST MENTIONED THAT THE ISSUE RECURRED WITH THE SECOND SCOPE DURING BIOPSYING. CONSEQUENTLY, THE PHYSICIAN DECIDED TO END THE PROCEDURE WITHOUT FURTHER BIOPSIES. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SCOPE ISSUES.

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.