ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM DUE TO ADVERSE PATIENT EFFECTS (FOOTDROP).

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

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

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

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

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

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

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

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

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.

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 A MONARCH BRONCHOSCOPY PROCEDURE AN E-STOP ERROR OCCURRED. THE PHYSICIAN WAS UNABLE TO CLEAR THE E-STOP ERROR AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

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 AFTER A SUCCESSFUL DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, THE PATIENT DEVELOPED A PNEUMOTHORAX AND LATER PASSED AWAY. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ADVERSE EVENT. PER THE ACCOUNT MANAGER, HOSPITAL ENDO MANAGEMENT DOES NOT ATTRIBUTE THE PNEUMOTHORAX OR THE SUBSEQUENT DEATH TO ANY DEFICIENCY OF THE MONARCH SYSTEM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INFORMED THAT ONE CASE OF L1-L4 MIS FIXATION WITH INTRAOP (O-ARM)WORKFLOW WAS BEING DONE AND THE PLANNING WAS DONE AFTER REGISTRATION. SURGEON HAD ALREADY PLACED L1 LEFT, L2 LEFT & L3 LEFT SCREWS. AFTER DRILLING IN L4 LEFT PEDICLE, SURGEON HAS CHECKED WITH BALL TIP PROBE AND OBSERVED THAT SOMETHING WAS WRONG, AND HE STOPPED THE PROCEDURE. AFTER CHECKING WITH C-ARM SHOT IT WAS FOUND THAT ALL THREE PLACED SCREWS ARE NOT AS PER THE PLAN AND ALL THE SCREWS WERE SHIFTED MEDIALLY AND CAUDALLY. AFTER THAT SURGEON HAS STOPPED USING ROBOT AND REPOSITIONED ALL THE SCREWS MANUALLY.

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 GERMANY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS WAS AN INTRAOP ADOLESCENT SCOLI CASE T4-L5 WITH A SIEMENS CIOS SPIN. WE DIVIDED THE CASE INTO THREE SEGMENTS (L2-L5, T9-T11 AND T4-T6) AND REIMAGED THE PATIENT. APPARENTLY, THE TECHNICIAN CANNOT ISOLATE THE SINGLE SCAN, SO ALL SCANS WERE TRANSFERRED WITH THE LAST ONE. DURING THE NAVIGATION ON THE LAST SEGMENT, THE IMAGE OF THE SCAN WAS KIND OF TORN AND THE SAGITTAL AND AXIAL PLANE LOOKED ALIKE. RESET SOFTWARE, HARD DID NOT HELP, DID A HARD SHUTDOWN AND RESTART. THE ISSUE WITH THE SCAN WAS STILL THERE AND COULD NOT BE SOLVED. THE LAST THREE TRAJECTORIES WERE DRILLED WITH THE ROBOT, BUT SCREWS WERE INSERTED FREEHANDED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: GPS UNIT IS HAVING HARD DRIVE ISSUES. IT WILL ONLY DISPLAY A BLACK SCREEN WHEN BOOTING UP STATING "REBOOT AND SELECT PROPER BOOT DEVICE OR INSERT BOOT MEDIA IN SELECTED BOOT DEVICE AND PRESS A KEY."

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 CASE WAS AN L4-S1 ALIF 360 USING HEDRON IA AND CREO ONE HARDWARE. THERE WAS NO PRIOR HARDWARE IN THE PATIENT. THE EGPS WORKFLOW WAS INTRA-OP CT. THE EGPS IS RUNNING SOFTWARE VERSION 1_1R3. THE PATIENT WAS POSITIONED PRONE FOR THE POSTERIOR PORTION AND THE CAMERA WAS POSITIONED AT THE FOOT OF THE BED. AN O-ARM WAS USED FOR IMAGING AND REGISTRATION. DR. (B)(6) PLACED THE DRB AT RIGHT PSIS WITH THE LOW-PROFILE QUATTRO SPIKE AND SURVEILLANCE MARKER AT LEFT PSIS. SURVEILLANCE WAS REGISTERED PRIOR TO THE ICT BEING POSITIONED ON THE QUATTRO SPIKE. THE ICT WAS POSITIONED, THE BED WAS RAISED, AND THE SURGICAL SNAPSHOT WAS TAKEN. THE O-ARM SPIN WAS ACQUIRED AND TRANSFERRED SUCCESSFULLY TO EGPS VIA ETHERNET. ALL 7 FIDUCIALS WERE CAPTURED SUCCESSFULLY, AND THE REGISTRATION FIT WAS DOWN ON GREEN. DR. (B)(6) PERFORMED LANDMARK CHECKS ON THE ICT FIDUCIALS AS WELL AS DOWN THE LOW-PROFILE QUATTRO SPIKE. NAVIGATION APPEARED TO EVERYONE IN THE ROOM TO BE ACCEPTABLE AND OF HIGH QUALITY. FOLLOWING PERCUTANEOUS PLACEMENT OF ALL SCREWS THROUGH BILATERAL WILTSY INCISIONS, A POST-OP REGISTRATION O-ARM SPIN WAS ACQUIRED. DR. (B)(6) DECIDED TO DO THIS PRIOR TO LOCKING THE CONSTRUCT DOWN AS HE QUESTIONED

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEONS COMPLAINT WAS THE FACT THAT WHILE ATTEMPTING TO MERGE THE L2 VERTEBRAL BODY, HE WAS UNABLE TO GET A BETTER MERGE BECAUSE OF THE LORDOTIC SHIFTING.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WE WERE INSTRUMENTING PEDICLE SCREWS AT T12 & L2 , SKIPPING THE FRACTURE LEVEL. THE E3D SPIN WENT FINE, AND INITIAL NAV INTEGRITY CHECKS SEEMED FINE AS WELL. WE PLACED ALL 4 SCREWS AT T12 / L2. WE BATTLED A LITTLE BIT OF SAVING BUT NOTHING SIGNIFICANT. WE TOOK AP SHOT AFTER SCREWS WERE PLACED, AND ALL FOUR SCREWS WERE COMPLETELY OUT OF THE PEDICLE. THE LEFT SIDE WAS LATERAL, AND RIGHT SIDE WAS MEDIAL.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ALL OUR SCREWS WERE ON, WE USED PRE OP CT WORKFLOW WITH G-ARM. THEN WE TOOK AN X-RAY OF OUR LATERAL TRIAL, AND THE NAVIGATION WAS ON. WHEN PLACING THE IMPLANT, WE WERE 4/5MM OFF POSTERIOR. WE HAD TO GO BACK IN, OPEN THE PATIENT, RETRIEVE THE CAGE AND RE DO EVERYTHING, NAVIGATION APPEARED TO BE ON UP UNTIL THE CAGE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: APOLOGIES, ORIGINAL REPORT DID NOT PROCESS. LOGS HAVE BEEN UPLOADED TO INR PORTAL. THERE WAS A SUSPECTED ISSUE WITH THE PREOP REGISTRATION/MERGE. T12 FRACTURE, SCREWS PLACED AT T10-11, L1-2. NAMELY, T11-L WAS PLACED LATERAL TO THE ORIGINAL PLACE. ADDITIONALLY, T10 SCREWS PLACED PROUD. AFTER DISCUSSION, SUSPECTED MISSTEP MAY HAVE BEEN PROPER PLACEMENT OF FLUORO FIXTURE BUT NO YET CAUSE DETERMINED. SCREWS WERE REPOSITIONED VIA TRADITIONAL MIS JAMSHID TECHNIQUE.

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 WAS ADJUSTING THE SCOPE TOWARDS TARGET OF NODULE AND THE PATIENTS HEART RATE (HR) BEGAN TO DECLINE AND THE PHYSICIAN ABORTED THE CASE. THE PATIENT THEN WENT INTO ASYSTOLE AND REQUIRED EMERGENT CONVERSION AND CHEST COMPRESSIONS. ONCE THE PATIENT REGAINED A PULSE THE WERE TRANSPORTED THE INTENSIVE CARE UNIT (ICU) WHERE THE PATIENT CODED AGAIN AND WAS BEING SENT TO THE CARDIAC CATH LAB. THE PHYSICIAN STATED THAT THE ADVERSE EVENTS ARE NOT ATTRIBUTED TO THE MONARCH SYSTEM.

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 WAS ADJUSTING THE SCOPE TOWARDS TARGET OF NODULE AND THE PATIENTS HEART RATE (HR) BEGAN TO DECLINE AND THE PHYSICIAN ABORTED THE CASE. THE PATIENT THEN WENT INTO ASYSTOLE AND REQUIRED EMERGENT CONVERSION AND CHEST COMPRESSIONS. ONCE THE PATIENT REGAINED A PULSE THE WERE TRANSPORTED THE INTENSIVE CARE UNIT (ICU) WHERE THE PATIENT CODED AGAIN AND WAS BEING SENT TO THE CARDIAC CATH LAB. THE PHYSICIAN STATED THAT THE ADVERSE EVENTS ARE NOT ATTRIBUTED TO THE MONARCH SYSTEM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PLANNED SURGERY ON THE DORSAL CERVICAL SPINE INCLUDED A SCREW FIXATION C1/C3/C4. WHEN CHECKING THE SCREW POSITION IN THE 3D SCAN AFTER SCREW PLACEMENT, THE SURGEONS WERE NOT SATISFIED WITH THE SCREW POSITION OF A C1 SCREW. A NEW 3D SCAN WAS PERFORMED AND A NEW C1 SCREW WAS PLANNED INTRAOPERATIVELY. WHEN APPROACHING THE TRAJECTORY, THE ROBOTIC ARM STOPPED FAR AWAY FROM THE FINAL POSITION AND ONLY SHOWED A YELLOW FRAME. THE END EFFECTOR WAS SO FAR AWAY THAT THE INSTRUMENTS DID NOT REACH THE BONE. RESETTING THE SOFTWARE AND MOVING THE ROBOT ARM MANUALLY DID NOT CHANGE ANYTHING. BECAUSE THE ROBOT ARM WAS TOO FAR AWAY, THE C1 SCREW HAD TO BE INSERTED MANUALLY (WITH NAVIGATION OF THE ROBOT), BUT NOT BY THE END EFFECTOR.

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 REPEATED SYSTEM FAULTS OCCURRED DURING A MONARCH BRONCHOSCOPY. THE PHYSICIAN TRIED MULTIPLE BRONCHOSCOPES, BUT THE SYSTEM CONTINUED TO FAULT. THE PHYSICIAN ELECTED TO ABORT THE DIAGNOSTIC PROCEDURE. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED DUE TO THIS 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 A SCREW USING THE EXCELSIUS GPS SYSTEM WAS MISPLACED INTRA-OPERATIVELY CAUSING A SCREW TO BREACH THE PATIENT'S SPINAL CANAL.

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: CAMERA IS BROKEN FULL DESCRIPTION ENTIRE SYSTEM NEEDS TO BE RUN FOR BUGS CAMERA IS BROKEN STORAGE IS LOW AND COMPUTER IS SLOW NEED TO BE DONE ASAP.

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 PHYSICIAN OBSERVED EXCESS AMOUNT OF BLOOD IN THE AIR WAY AFTER SUCCESSFULLY COMPLETING THE MONARCH BRONCHOSCOPY PROCEDURE. THE PHYSICIAN ELECTED TO USE THEIR MANUAL BRONCHOSCOPE AND COLD SALINE TO CLEAR THE AIRWAY; HOWEVER, COMPLICATIONS OCCURRED DURING THE POST-MONARCH BRONCHOSCOPY PROCEDURE. THE PATIENTS BLOOD HAD CLOTTED AND BLOCKED THE ENDOTRACHEAL TUBE (ET TUBE). THE PATIENT THEN FELL INTO CARDIAC ARREST DUE TO LACK OF VENTILATION FROM THE FROM THE BLOOD CLOT BEING PRESENT IN THE ENDOTRACHEAL TUBE (ET TUBE). THE PHYSICIAN FOLLOWED CARDIAC ARREST PROTOCOL AND WAS ABLE TO RECOVER THE PATIENT. THE PATIENT WAS ADMITTED INTO INTENSIVE CARE UNIT (ICU) ON THE SAME DAY. AFTER THE PATIENT WAS SENT TO RECOVERY IN THE INTENSIVE CARE UNIT (ICU), THE PATIENT WAS GIVEN A CHEST X-RAY WHERE DOCTOR DISCOVERED THE PATIENT HAD EXPERIENCED A PNEUMOTHORAX. A CHEST TUBE WAS PLACED AND REMOVED THE FOLLOWING DAY. THE PHYSICIAN STATED THE PNEUMOTHORAX WAS DUE TO LONG BAG VENTILATION TIME, EXCESS SUCTION, AND OVER ALL STRESS ON THE LUNG THAT OCCURRED DURING BLEEDING MANAGEMENT POST-MONARCH PROCEDURE. THE PATIENT HAS BEEN RELEASED FROM THE HOSPITAL.

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 DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, THE PHYSICIAN DECIDED TO ABORT THE DIAGNOSTIC PROCEDURE DUE TO NAVIGATIONAL DIFFICULTY AND POOR VISIBILITY. PATIENT MUCUS CONTRIBUTED SIGNIFICANTLY TO THE POOR VISIBILITY. THE PHYSICIAN DECIDED TO CONVERT THE DIAGNOSTIC PROCEDURE TO A MANUAL BRONCHOSCOPY PROCEDURE. IT WAS REPORTED THAT THE PATIENT DEVELOPED A PNEUMOTHORAX AND A CHEST TUBE WAS PLACED.

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: TRYING TO START A CASE AND THE ROBOT WENT TO REBOOT AND SELECT PROPER BOOT DEVICE. NEED AN FSE FOR TOMORROW'S CASE WITH A NEW SURGEON.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING ROBOTIC REGISTRATION THE FLUORO SHOTS AND PRE-OP CT SCAN DID NOT ALIGN PROPERLY. WITH CLEAR FLUORO PHOTOS IT LOOKED AS IF THE ROBOT WAS PULLING AN OBLIQUE CT SLICE. WE HELD RESPIRATION, CENTERED EACH VERTEBRAE, SOFTWARE RESET, SWITCHED TO CRANIAL AND BACK WITH NO SUCCESS. I USED LIFE SAVER, BUT AT THAT POINT DR. (B)(6) CHOSE NOT TO CONTINUE WITH THE ROBOT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS THE INTRA-OP SPINE CASE. UNFORTUNATELY, THE TEAM COULDN'T GET THE AUTOMATIC REGISTRATION. IT HAD BEEN DONE ANOTHER SCAN WITH THE SAME RESULT. AFTER THE REGISTRATION WAS DONE MANUALLY, THE SURGEON NOTICED SOME NAVIGATION SHIFTS. THE ROBOTIC CASE WAS ABORTED AND DONE TRADITIONALLY. NO ADVERSE EFFECTS FOR THE PATIENT.

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 HARDWARE ERROR. 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: IT WAS REPORTED THAT A SCREW USING THE EXCELSIUS GPS SYSTEM WAS MISPLACED INTRA-OPERATIVELY CAUSING A LARGE BLEED.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ALL POWER LOST TO EGPS UNIT WHILE UNIT WAS PLUGGED INTO A VIABLE/TESTED POWER SOURCE. POWER SOURCE WAS USED IN TWO CASES DURING THE SAME DAY (B)(6) 2023. ALL FUNCTION AND AGENCY LOST TO THE EGPS UNIT DURING THIS TIME. BOTH THE BATTERY SYMBOL AND ON/OFF SYMBOL WERE NOT EMITTING ANY COLOR.

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. THIS EVENT OCCURRED IN AUSTRALIA.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SCREWS L2-S1, ALL LEFT SCREWS MEDIAL AND ALL RIGHT SCREWS LATERAL. WHEN REMOVING SCREWS, INITIALLY OUR SPIN WAS CORRECT AND NAVIGATION INTEGRITY WAS SOLID; HOWEVER, AFTER REMOVING ONE OR TWO MORE SCREWS, WHEN THE CHICKEN FOOT WAS AGAIN PLACED DOWN THE SCREW TRAJECTORY TO CONFIRM NAVIGATION ACCURACY, THE SCREW APPEARED TO BE MEDIAL TO WHERE THE TOOL WAS PLACED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS NOT POSSIBLE TO UPLOAD THE PLANNED CASE FROM LAPTOP TO THE ROBOT WITH USB STICK. WE GOT THE MESSAGE ''GPS CLIENT IS NOT RESPONDING''. SOFTWARE RESET, HARD SHUTDOWN DIDN'T HELP. THE SCREEN WAS FROZEN WITH THE MESSAGE ''IMPORTING CASE FROM USB''. THE CASE WAS DONE IN TRADITIONAL WAY.

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 A SYSTEM FAULT OCCURRED DURING SETUP FOR A MONARCH BRONCHOSCOPY. THE PHYSICIAN ELECTED TO NOT START THE DIAGNOSTIC PROCEDURE. THE PATIENT HAD ALREADY BEEN ANESTHETIZED. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED DUE TO THIS EVENT. (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, AURIS HEALTH, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

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 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: IT WAS REPORTED THAT A PATIENT EXPERIENCED ADVERSE EFFECTS FOLLOWING SURGERY WHERE SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING AN INTRA-OP DBS CASE AT (B)(6) MEDICAL CENTER, A 2ND O-ARM EVALUATION SPIN SHOWED THAT THE LEAD WAS ~2 MM SUPERFICIAL TO THE PLANNED DEPTH. THE PLANNED DEPTH WAS 2 MM PAST THE TARGET BASED ON THE BURNED IN BRAINLAB LEFT VIM TRAJECTORY. FROM THE FIRST EVALUATION SPIN, THE LEAD WAS 6.5 MM ABOVE THE PLANNED DEPTH AND 4.5 MM ABOVE THE BURNED IN TARGET. AFTER OBSERVING THE RESULTS FROM THIS FIRST SPIN, DR. (B)(6) STATED THAT HE MAY HAVE PULLED BACK ON THE LEAD WHEN REMOVING THE CANNULA. HE WENT BACK IN AND MANUALLY ADVANCED THE LEAD 6.5 MM FURTHER TO ACCOUNT FOR THE DEPTH DISCREPANCY WHILE HAVING HIS PA PERFORM LFPS ON THE PATIENT. AFTER HE ADVANCED THE LEAD TO HIS DESIRED DEPTH, A 2ND EVALUATION SPIN WAS PERFORMED. THE RESULT OF THIS SPIN SHOWED THAT THE LEAD WAS EXACTLY TO TARGET DEPTH, WHICH IS 2 MM SUPERFICIAL FROM HIS PLANNED DEPTH.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FOR A SINGLE POSITION LATERAL CASE AT L4-5 DURING CASE SET UP THE END EFFECTOR LATCH WAS VERY STICKY AND HARD TO CLOSE. AFTER THE FIRST MERGE WITH PREOP CT WORK FLOW WE RECEIVED A HIGH SURVEILLANCE MESSAGE, SO WE REMERGED AND RESETTLED SURVEILLANCE. AFTER DRILLING THE FIRST PEDICLE L4 LEFT IT DID NOT FEEL OR LOOK RIGHT SO WE BROUGHT IN FLUORO. THE LATERAL WAS TO PLAN BUT THE AP WAS VERY MEDIAL. WE AGAIN REMERGED AND RESETTLED SURVEILLANCE. WE SWITCHED OUT THE END EFFECTOR AND, ON THE 3RD, TRY WE WERE ABLE TO ACCURATELY PLACE BILATERAL PEDICLE SCREWS. WE NEED TO REPLACE THE END EFFECTOR. I WILL UPLOAD CASE LOGS FOR THIS CASE TO THE ECL MODULES.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WE PLACED QUATTRO SPIKE IN RIGHT PSIS AND SURVEILLANCE MARKER IS LEFT PSIS. WE TOOK X-RAYS FOR THE MERGE, AND ALL CONFIRMED L4 AND L5 VERTEBRAL BODIES. THE MERGE WAS SUCCESSFUL, AND X RAY CAME OUT. AT THIS POINT, THE REP HAD NOTICED THAT THE DRB ON THE LEFT WAS CLOSE TO PATIENT AND ASKED IF IT HAD BEEN LIKE THAT. I ASKED THE SURGEON IF THERE WAS A GAP, SURGEON CONFIRMED THAT THERE WAS. ROBOT WAS BROUGHT IN, AND STABILIZERS WERE PLACED. SURGEON MOVED FORWARD WITH PLACING LEFT L4, INSTRUMENTS DIDN'T LOOK RIGHT ON NAVIGATION, BUT SURGEON FELT FINE. WE DID L5 AND SAW SAME NAVIGATION ISSUE AFTER PLACING SCREW WE DECIDED TO TAKE A X RAY TO CONFIRM AND NOTICED WE WERE OFF. SURGEON THEN HAD ROBOT TAKEN OUT AND OPENED PATIENT UP. SCREWS REMOVED AND HE FINISHED THE PROCEDURE.