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).

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REVIEW OF AN ARTICLE WAS COMPLETED OF A RANDOMIZED CONTROLLED TRIAL BASED ON DA VINCI-ASSISTED ROBOTIC PANCREATICODUODENECTOMY (RPD) WHERE THE AUTHORS COMPARED THE SHORT-TERM POSTOPERATIVE OUTCOMES OF RPD WITH THOSE OF OPEN PANCREATICODUODENECTOMY (OPD). THE TRIAL, CONDUCTED BETWEEN MARCH 5 AND DECEMBER 20, 2022, INCLUDED 164 PATIENTS RANDOMLY ASSIGNED TO EITHER THE RPD OR OPD GROUP. IN THE RPD GROUP, THERE WAS ONE IN-HOSPITAL DEATH (1%) WITHIN 90 DAYS AFTER THE OPERATION. SPECIFICALLY, ONE (1%) OF 81 PATIENTS IN THE RPD GROUP DEVELOPED POSTOPERATIVE PANCREATIC FISTULA RELATED HEMORRHAGE ON POSTOPERATIVE DAY 9, UNDERWENT TRANS-ARTERIAL EMBOLIZATION AND A SUBSEQUENT REOPERATION, BUT DIED OF SEPTIC SHOCK ON DAY 30. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED. THE OPD SUBSET ALSO HAD ONE PATIENT DEATH DUE TO A PULMONARY EMBOLISM ON POSTOPERATIVE 5. THE ARTICLE STATES THAT WHILE RPD SHOWED BENEFITS IN REDUCING HOSPITAL STAY, THE OVERALL CLINICAL BENEFIT REMAINS UNCLEAR, ESPECIALLY CONSIDERING THE EXTRA COSTS AND PATIENT PERCEPTIONS OF QUALITY OF LIFE AND RECOVERY AFTER DISCHARGE.

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.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A DIAGNOSTIC MONARCH BRONCHOSCOPY, THE PHYSICIAN BIOPSIED SAMPLES AT THE RIGHT UPPER LOBE (RUL) 3CM FROM THE TARGET. AS THE PHYSICIAN REPOSITIONED THE BRONCHOSCOPE, A ROBOTIC ARM FAULT STATE OCCURRED. THE PHYSICIAN WAS NOT ABLE TO GET ALL OF HIS BIOPSIES DUE TO THIS FAULT CONDITION 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 THE PATIENT EXPERIENCED A PNEUMOTHORAX MEDIASTINAL. NO MEDICAL INTERVENTION WAS REQUIRED. HOWEVER, THE PATIENT WAS HOSPITALIZED DUE TO OTHER MEDICAL ISSUES, FOR OBSERVATION ONLY UNRELATED TO MONARCH DEVICE. THERE WERE NO FAULTS OR ISSUES REPORTED WITH THE MONARCH SYSTEM AND THE PHYSICIAN IS NOT ATTRIBUTING THE EVENT TO THE MONARCH.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PROCEDURE WAS A L3-5 OPEN/MIDLINE RIGHT TLIF USING A PRE-OP CT WORKFLOW. 9' FLOURO FIXTURE WAS USED WITH A OEC 9900 ELITE C ARM. SURGEON IDENTIFIED A MEDIAL BREACH OF THE RIGHT L3 SCREW.

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 CSF (CEREBRAL SPINAL FLUID) LEAK.

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 A DIAGNOSTIC MONARCH BRONCHOSCOPY PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY WHILE DRIVING THROUGH THE BRONCHIAL ANATOMY TO THE TARGET LOCATION IN THE RIGHT UPPER LOBE (RUL). THE PATIENT ANATOMY REQUIRED THE BRONCHOSCOPE TO MANEUVER THROUGH A DIFFICULT/TIGHT SHARP TURN. THE MONARCH SYSTEM PRODUCED MULTIPLE FAULT CODES. THE PHYSICIAN WAS NOT ABLE TO REACH THE TARGET AND ELECTED TO ABORT THE DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE 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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER MAKING TRACKS IN L4-R, L3-R, L2-R AND L1-R, SURGEON WAS ABOUT TO USE BUR IN T12-R AND HE OBSERVED THAT THE BUR POSITION IS NOT RIGHT AS PER THE ANATOMY AND THE PLANNED TRAJECTORY WHILE THE POSITIONING OF THE ARM WAS GOOD ON THE SCREEN. WE ASKED SURGEON TO CHECK THE ACCURACY BY USING AN INSTRUMENT AND T10-T12 LEVELS WERE NOT ACCURATE WHILE THE LUMBER AREA WAS ACCURATE. THERE WAS NOT ANY DRB/SURVEILLANCE SHIFT WARNING ON THE SYSTEM.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HELLO, THIS IS CONCERNING A DEFECTIVE MEDICAL DEVICE. THE DEVICE: THE MONARCH. MY PULMONOLOGIST USED IT AS HE HAD DONE WITH THE OTHER 300 PATIENTS BEFORE ME, TO PLACE A MARKER IN MY LUNG. I HAVE A POSSIBLE MALIGNANT NODULE. THE SURGEON WENT IN TO TAKE OUT THE NODULE BUT COULD NOT FIND IT. THE MARKER WAS IN THE WRONG PLACE!!! MY PULMONOLOGIST CALLED MONARCH BUT GOT NOWHERE. HE DID FIND OUT THEY HAD RECENTLY DID A SOFTWARE UPDATE. SOMETHING WAS DEFECTIVE IN THE MONARCH DEVICE USED. MY DOCTOR PUT IN A COMPLAINT WITH THE FDA. ANOTHER PROVIDER AT THE LUNG CLINIC, ALSO HAD A MALFUNCTION WITH THE MONARCH ON A RECENT PATIENT. HE ALSO REPORTED TO THE FDA. MY PULMONOLOGIST AND IS GROUP WILL BE TALKING WITH THE HOSPITAL ABOUT THIS DEVICE AND IF THEY SHOULD CONTINUE TO USE IT OR CHANGE TO SOMETHING ELSE. THE MONARCH MALFUNCTION HAS DERAILED EVERYTHING WITH MY CARE REGARDING GETTING THIS NODULE REMOVED. I HAVE SO MUCH INFLAMMATION SINCE THE SURGERY THAT I MUST WAIT UNTIL JUNE FOR ANOTHER CT (COMPUTED TOMOGRAPHY) TO CHECK ON THE NODULE. OVER (B)(6) IN DOCTOR BILLS AND A SURGERY THAT I SHOULD NOT HAVE HAD BECAUSE OF THE DEFECT. **PROCEDURE OCCURRED AT (B)(6) OPERATING ROOM. THANK YOU, (B)(6). I H

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN BETWEEN CASES SYSTEM FLAGGED ANOTHER "BUMP ERROR", THIS HAS HAPPENED 2 DAYS AFTER THE SITE HAD ANOTHER BUMP ERROR. THIS WAS RESOLVED VIA ACCURACY TEST PASS. SITE HAVE BEEN VIGILANT AND ASSURED ME THAT NO-ONE HAD IMPACTED THE CAMERA AND THE WARNING RANDOMLY APPEARED WHEN PREPPING FOR THE SECOND CASE.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE CLINICAL STUDY TRIAL CASE UNEXPECTED VIDEO QUALITY WAS OBSERVED ON URETEROSCOPE. THE UNEXPECTED VIDEO QUALITY CONSISTED OF BLURRINESS ON THE SYSTEM DISPLAY. THE BLURRY VISION WAS ONLY OBSERVED DURING MINI-PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE OF THE PRODUCT WORKFLOW, NAMELY DURING URETEROSCOPE DRIVING WITH THE LASER DRIVER COMPONENT CONNECTED. UPON REPLACEMENT OF THE URETEROSCOPE, NO FURTHER VIDEO ISSUES WERE OBSERVED AND THE USER COMPLETED THE CASE. UNDER PRELIMINARY INVESTIGATION THE URETEROSCOPE WAS EXAMINED UNDER MAGNIFICATION, AT WHICH TIME IT WAS DISCOVERED THAT THE TOP LAYER OF THE CAMERA LENS WAS MISSING. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

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 IT WAS NOTICED THAT THE ANTERIOR CUT WAS OFF. IT WAS ALSO REPORTED THAT THE ROBOTIC ASSISTED BASE STATION DEVICE WAS TAKING A LONG TIME TO BOOT UP AND THE POWER CORD WOULD NOT STAY SECURELY ATTACHED TO THE BASE STATION. IT WAS REPORTED THAT THE SYSTEM WAS WORKING HOWEVER THE POWER CORD IS CAUSING FRUSTRATION WITH THE SYSTEM SHUTTING DOWN. THERE WERE NO DELAYS IN THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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: THE PATIENT WAS SCHEDULED FOR A LUMBAR FUSION WITH SPINAL INSTRUMENTATION USING COMPUTER NAVIGATION AND ROBOTIC ASSISTANCE USING THE GLOBUS MEDICAL EXCELSIUS 3D IMAGING SYSTEM. I HAD BEEN NOTIFIED BY THE GLOBUS REPRESENTATIVE ON THE MORNING OF SURGERY THAT THERE WAS A POTENTIAL PROBLEM WITH THE BATTERY SUPPLY OF THE GLOBUS IMAGING SYSTEM BUT THAT IT HAD BEEN ADDRESSED BY THE ENGINEERS AND THERE SHOULD BE NO PROBLEM. I WAS TOLD THAT EVEN IF THERE WAS A BATTERY ISSUE THE SYSTEM COULD RUN FROM ELECTRICAL POWER FROM THE WALL. ONCE THE PATIENT WAS ASLEEP AND THE EXPOSURE TO THE SPINE WAS COMPLETE, THE GLOBUS IMAGING SYSTEM WAS BROUGHT IN FOR OBTAINING THE IMAGES. IT IMMEDIATELY SHUT DOWN AND COULD NOT BE RESTARTED. AS A RESULT I WAS UNABLE TO PROCEED WITH THE COMPUTER NAVIGATION OR ROBOTIC ASSISTANCE THAT I HAD EXPLAINED TO THE PATIENT. MY OPTIONS WERE TO EITHER CANCEL THE SURGERY AND CLOSE THE WOUND TO RETURN ANOTHER DAY ONCE THE SYSTEM WAS WORKING OR PROCEED WITHOUT THE NAVIGATION AND ROBOTIC ASSISTANCE. I CHOOSE TO PROCEED WITH THE SURGERY USING THE TRADITIONAL APPROACH WITHOUT NAVIGATION OR ROBOTICS. FORTUNATELY THE SURGERY WENT WELL WITHOUT COMPLICATIONS. I WAS ABLE TO CONTINUE WIT

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PATIENT WAS SCHEDULED FOR A LUMBAR FUSION WITH SPINAL INSTRUMENTATION USING COMPUTER NAVIGATION AND ROBOTIC ASSISTANCE USING THE GLOBUS MEDICAL EXCELSIUS 3D IMAGING SYSTEM. I HAD BEEN NOTIFIED BY THE GLOBUS REPRESENTATIVE ON THE MORNING OF SURGERY THAT THERE WAS A POTENTIAL PROBLEM WITH THE BATTERY SUPPLY OF THE GLOBUS IMAGING SYSTEM BUT THAT IT HAD BEEN ADDRESSED BY THE ENGINEERS AND THERE SHOULD BE NO PROBLEM. I WAS TOLD THAT EVEN IF THERE WAS A BATTERY ISSUE THE SYSTEM COULD RUN FROM ELECTRICAL POWER FROM THE WALL. ONCE THE PATIENT WAS ASLEEP AND THE EXPOSURE TO THE SPINE WAS COMPLETE, THE GLOBUS IMAGING SYSTEM WAS BROUGHT IN FOR OBTAINING THE IMAGES. IT IMMEDIATELY SHUT DOWN AND COULD NOT BE RESTARTED. AS A RESULT I WAS UNABLE TO PROCEED WITH THE COMPUTER NAVIGATION OR ROBOTIC ASSISTANCE THAT I HAD EXPLAINED TO THE PATIENT. MY OPTIONS WERE TO EITHER CANCEL THE SURGERY AND CLOSE THE WOUND TO RETURN ANOTHER DAY ONCE THE SYSTEM WAS WORKING OR PROCEED WITHOUT THE NAVIGATION AND ROBOTIC ASSISTANCE. I CHOOSE TO PROCEED WITH THE SURGERY USING THE TRADITIONAL APPROACH WITHOUT NAVIGATION OR ROBOTICS. FORTUNATELY THE SURGERY WENT WELL WITHOUT COMPLICATIONS. I WAS ABLE TO CONTINUE WIT

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PATIENT WAS SCHEDULED FOR A LUMBAR FUSION WITH SPINAL INSTRUMENTATION USING COMPUTER NAVIGATION AND ROBOTIC ASSISTANCE USING THE GLOBUS MEDICAL EXCELSIUS 3D IMAGING SYSTEM. I HAD BEEN NOTIFIED BY THE GLOBUS REPRESENTATIVE ON THE MORNING OF SURGERY THAT THERE WAS A POTENTIAL PROBLEM WITH THE BATTERY SUPPLY OF THE GLOBUS IMAGING SYSTEM BUT THAT IT HAD BEEN ADDRESSED BY THE ENGINEERS AND THERE SHOULD BE NO PROBLEM. I WAS TOLD THAT EVEN IF THERE WAS A BATTERY ISSUE THE SYSTEM COULD RUN FROM ELECTRICAL POWER FROM THE WALL. ONCE THE PATIENT WAS ASLEEP AND THE EXPOSURE TO THE SPINE WAS COMPLETE, THE GLOBUS IMAGING SYSTEM WAS BROUGHT IN FOR OBTAINING THE IMAGES. IT IMMEDIATELY SHUT DOWN AND COULD NOT BE RESTARTED. AS A RESULT I WAS UNABLE TO PROCEED WITH THE COMPUTER NAVIGATION OR ROBOTIC ASSISTANCE THAT I HAD EXPLAINED TO THE PATIENT. MY OPTIONS WERE TO EITHER CANCEL THE SURGERY AND CLOSE THE WOUND TO RETURN ANOTHER DAY ONCE THE SYSTEM WAS WORKING OR PROCEED WITHOUT THE NAVIGATION AND ROBOTIC ASSISTANCE. I CHOOSE TO PROCEED WITH THE SURGERY USING THE TRADITIONAL APPROACH WITHOUT NAVIGATION OR ROBOTICS. FORTUNATELY THE SURGERY WENT WELL WITHOUT COMPLICATIONS. I WAS ABLE TO CONTINUE WIT

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THERE IS A RED LIGHT ON THE ROBOT, AND THE SYSTEM CAMERA REPORTED BING BUMPED.

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 A REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM DUE TO ADVERSE PATIENT EFFECTS.

da Vinci Surgical System — Death 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 UNEVENTFUL DA VINCI ASSISTED LOW ANTERIOR RESECTION FOR COLORECTAL CANCER. THE SURGEON STATED THAT THE ANASTOMOSIS WAS END-TO-END, CREATED WITH AN ETHICON ILS 29 CIRCULAR STAPLER. TESTING OF THE ANASTOMOSIS WAS PERFORMED DURING THE OPERATION AND NO LEAKAGE WAS FOUND. THE PATIENT EXPERIENCED COMPLICATIONS POSTOPERATIVELY AND EXPIRED APPROXIMATELY 69 DAYS POST-PROCEDURE. THERE WAS NO REPORT OF ANY ISSUES WITH THE DAVINCI PRODUCTS. ON POST-OPERATIVE DAY 4 (POD) THE PATIENT'S BLOOD PRESSURE SIGNIFICANTLY DROPPED AND CT SCANS SHOWED PNEUMOPERITONEUM. ANASTOMOSIS LEAKAGE, PERITONITIS, AND SEPSIS WERE SUSPECTED AND AN EMERGENT RE-OPERATION WAS PERFORMED. THE PATIENT REQUIRED POST-OPERATIVE CIRCULATORY AND OXYGEN SUPPORT VIA VENO-ARTERIAL AND VENO-VENO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND VASOPRESSORS DUE TO RESPIRATORY FAILURE AND SEPTIC SHOCK. ON POD 7 THE CIRCULATORY SUPPORT WAS CHANGED TO VENO-VENOUS ECMO ONLY, WHICH WAS REMOVED FIVE DAYS LATER AFTER THE PATIENT WAS HEMODYNAMICALLY STABLE. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR ILEOSTOMY AND WOUND INFECTIONS. THE PATIENT'S HAND BECAME CYANOTIC FROM THE ECMO TREATMENT REQUIRI

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR. (B)(6) WAS DOING A T3-T12 PEDIATRIC SCOLIOSIS PATIENT. SIGNIFICANT CORONAL AND SAGITTAL DEFORMITY AT MULTIPLE LEVELS. WE WERE USING A 12INCH C-ARM. MERGE FAILED AFTER MULTIPLE ATTEMPTS OF HAVING THE X-RAY TECH WAG THE C-ARM IN LATERAL, RAINBOW IN A/P, AND TRY OBLIQUE IN LATERAL AT HIGH LEVELS. TRIED MULTIPLE LATERALS AND A/P WITH NO AVAIL. SURGEON WAS VERY PATIENT AND GAVE US THE TIME BUT EVENTUALLY BAILED ON THE ROBOT. HE PROCEEDED WITH DOING THE CASE FREE HAND.

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 PATIENT EXPERIENCED A PNEUMOTHORAX IN THE RIGHT LUNG. A CHEST TUBE WAS PLACED AND PATIENT WAS HOSPITALIZED. THE FOLLOWING DAY THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS RELEASED. THE PHYSICIAN STATED THAT THE SCOPE APPEARED TO BE KINKED AND THE PHYSICIAN ELECTED TO ABORT THE CASE.

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 REPORTED THAT THE NAVIGATION WAS NOT MATCHING UP WITH THE CIOS SPIN AND WAS ~30MM OFF FROM THE TARGET BUT THE CASE WAS COMPLETED SUCCESSFULLY. A PNEUMOTHORAX WAS DISCOVERED POST-OP AND THE PATIENT WAS NOT ADMITTED BUT A CHEST TUBE WAS PLACED. CHEST TUBE WAS REMOVED SAME DAY AND THE PATIENT WENT HOME SAME DAY. THERE WERE NO FAULTS OR ISSUES REPORTED WITH THE MONARCH SYSTEM AND THE PHYSICIAN IS NOT ATTRIBUTING THE EVENT TO THE MONARCH.

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 MERGE OF L4-5 LEVELS FOR SINGLE POSITION LATERAL SURGERY SHOWED A SHIFT. WE TOOK NEW SHOTS OF EACH INDIVIDUAL LEVEL AND ADDED L3 AND S1 TO HELP WITH THE MERGE. THE SURGEON WAS UNHAPPY WITH THE MERGE AS THERE WAS SLIGHT MOVEMENT VISIBLE ON THE L4 AND L5 A/P AND LATERAL VIEWS. THE SINGLE POSITION LATERAL CASE WAS ABORTED AND CONVERTED TO AN OPEN PRONE TLIF. PLEASE NOTE THE BED WAS ADJUSTED TO HELP ACCOMMODATE THE ILIAC CREST PRIOR TO ROBOTIC X RAYS BEING TAKEN.

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 WHEN VERIFYING THE CUTS ON THE FEMUR, IT APPEARED THAT THE LATERAL POSTERIOR CUT HAD BEEN OVER RESECTED BY 1MM WHEN USING VELYS. WHEN SURGEON PUT TRIALS ON, HE NOTICED CONSIDERABLE 1-2MM GAPS BETWEEN BONE AND TRIAL FEMUR FOR THE: POSTERIOR, ANTERIOR, ANTERIOR CHAMFER AND DISTAL. LEFT TKR USING VELYS ATTUNE PS FB CONSTRUCT.

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.