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 SCREW WAS MISPLACED USING THE EXCELSIUS GPS SYSTEM.

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 A ROSA SHOULDER PROCEDURE, REAMING RESULTED IN AN OBLONG HOLE DUE TO HARD BONE. THE SURGEON GRAFTED THE OBLONG DEFECT CREATED BY THE REAMING. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY X-RAY 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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND REMAINING 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: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED DURING SURGERY.

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 DURING THE MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A BLEED. THE PHYSICIAN REPORTED THE BLEEDING WAS NOT DUE TO MONARCH BUT RATHER JUST A RISK OF BIOPSYING THIS SPECIFIC PATIENT. THE PATIENT WAS ADMITTED FOR OBSERVATION ONLY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THERE WAS A RED TAG ERROR DURING CASE SET UP. "PIB HARDWARE COMMUNICATION STOPPED."

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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND. THIS EVENT OCCURRED IN (B)(6).

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 THE MONARCH BRONCHOSCOPY PROCEDURE THE ARMS WERE STUCK IN STOW POSITION AND WILL NOT RESPOND. THE PHYSICIAN POWER CYCLED THE MONARCH SYSTEM A COUPLE OF TIMES AND RECONNECTED THE SYSTEM; HOWEVER, THERE WAS NO CHANGE. THE PHYSICIAN ELECTED TO ABORT THE CASE AND RESCHEDULE FOR A LATER DATE. THERE WAS NO REPORT OF AN ADVERSE EVENT DUE TO SYSTEM 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.

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 THE PROCEDURE PATIENT EXPERIENCE ABDOMINAL DISTENTION AND RESPIRATORY DISTRESS AND WAS HOSPITALIZE AND DRAIN PLACEMENT WAS PERFORM.

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. THIS EVENT OCCURRED IN IRELAND.

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