da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ADRENALECTOMY SURGICAL PROCEDURE, WHEN THE SYNCHROSEAL INSTRUMENT WAS BEING REMOVED, IT MADE SOME ABNORMAL MOVEMENTS AND A SMALL PIECE OF IT FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON DOES NOT KNOW WHAT CAUSED THE FRAGMENT FAILING ISSUE. THE EXACT TIME OF HOW LONG THE INSTRUMENT WAS IN USE PRIOR TO THE ISSUE OCCURRING WAS UNKNOWN, BUT IT WAS DURING THE INITIAL WORK. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE SURGEON SAW THE FRAGMENT FALL AS THE INSTRUMENT WAS BEING REMOVED. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. THERE WERE NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THERE WAS NO PATIENT INJURY. THE PATIENT HAD NOT RETURNED TO T

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE AT (B)(6) WAS A L4/L5 OPEN TLIF WITH CREO AMP USING THE PREOP WORKFLOW ON AN EGPS SYSTEM THAT IS RUNNING SPINE 1.4. EXPOSURE WAS MADE AND DRB WAS PLACED ON A SPINOUS PROCESS CLAMP AT L3 WITH THE CAMERA AT THE HEAD. SURVEILLANCE WAS PLACED IN LEFT PSIS. FLOURO IMAGES WERE ACQUIRED FOR REGISTRATION AND DUE TO SOME PRIOR ISSUES WITH THE MERGE, CAREFUL ATTENTION WAS PAID TO GETTING MORE TRUE IMAGES AND ALSO TO KEEP THE DRB AS MUCH OUT OF THE SHOTS AS POSSIBLE AS TO NOT INTERFERE WITH THE FIXTURE BBS. AFTER THE MERGE WAS RUN, IT WAS DETERMINED THAT AT L4 THE WAS SOME ANTERIOR POSTERIOR SHIFT IN THE LATERAL. ANOTHER REGISTRATION TYPE WAS SELECTED AND DEEMED SATISFACTORY. DUE TO THE INCISION, DR. (B)(6) ELECTED TO START AT L4 AND WORKED TOWARD L5. THE LAST SCREW PLACED WAS L5R AND A LOT OF RETRACTION WITH A VERSATRAC WAS USED TO BE ABLE TO PLACE SCREW INSIDE THE INCISION. UNFORTUNATELY DO THE WORKFLOW AND ROOM SET UP, SURVEILLANCE WAS UNABLE TO BE SEEN. UPON XRAY CONFIRMATION SHOTS, IT WAS DETERMINED THAT THE L5R SCREWS WAS LATERAL TO THE PLAN. THE SCREW WAS REMOVED, AND AN ACCURACY CHECK WAS PERFORMED AND DEEMED SATISFACTORY. THE SCREW WAS REINSERTED UNDER A NEW PLAN AFTER FREE HAND

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HERNANDEZ, N. S., DIAZ-AGUILAR, L. D., & PHAM, M. H. (2023). SINGLE POSITION L5-S1 LATERAL ALIF WITH SIMULTANEOUS ROBOTIC POSTERIOR FIXATION IS SAFE AND IMPROVES REGIONAL ALIGNMENT AND LORDOSIS DISTRIBUTION INDEX. EUROPEAN SPINE JOURNAL. HTTPS://DOI.ORG/10.1 007/S00586-023-07841-Y. PURPOSE: MINIMALLY INVASIVE SINGLE POSITION LATERAL ALIF AT L5-S1 WITH SIMULTANEOUS ROBOT-ASSISTED POSTERIOR FIXATION HAS TECHNICAL AND ANATOMIC CONSIDERATIONS THAT NEED FURTHER DESCRIPTION. METHODS: THIS IS A RETROSPECTIVE CASE SERIES OF SINGLE POSITION LATERAL ALIF AT L5-S1 WITH ROBOTIC ASSISTED FIXATION. END POINTS INCLUDED RADIOGRAPHIC PARAMETERS, LORDOSIS DISTRIBUTION INDEX (LDI), COMPLICATIONS, PEDICLE SCREW ACCURACY, AND INPATIENT METRICS. RESULTS: THERE WERE 17 PATIENTS WITH MEAN AGE OF 60.5 YEARS. EIGHT PATIENTS UNDERWENT INTERBODY FUSION AT L5-S1, FIVE PATIENTS AT L4-S1, TWO PATIENTS AT L3-S1, AND ONE PATIENT AT L2-S1 IN SINGLE LATERAL POSITION. OPERATIVE TIMES FOR 1-LEVEL AND 2-LEVEL CASES WERE 193 MIN AND 278 MIN, RESPECTIVELY. MEAN EBL WAS 71 CC. MEAN IMPROVEMENTS IN L5-S1 SEGMENTAL LORDOSIS WERE 11.7 ± 4.0°, L1-S1 LORDOSIS OF 4.8 ± 6.4°, SAGITTAL VERTICAL AXIS OF - 0.1 ±1.7 CM°, PELVIC TILT

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PRE-OP BASED L3-L5 OPEN CASE WAS BEING PERFORMED AND THE MERGE LOOKED GOOD BY VERIFYING THE ANATOMICAL LANDMARK. AS IT WAS AN OPEN CASE, SURGEON HAS NOT USED SM TO AVOID AN ADDITIONAL INCISION/FIXATION ON PSIS. AFTER PLACING ALL THE SIX SCREWS A POST OP XRAY HAS BEEN TAKEN. FIRST SCREW I.E. L3-L WAS NOT PLACED AS PER THE PLAN AND ENTERED INTO L2-L3 DISK. THERE WAS NO ADVERSE EFFECT TO PATIENT AND THE SCREW WAS CORRECTED MANUALLY. REST ALL OTHER SCREWS WERE FINE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT HAS HAD MULTIPLE DIFFERENT FAILURES OF THE STABILIZER ENGAGEMENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT A RECOVERABLE FAULT WAS REOCCURRING EACH TIME THE RECOVER FAULT WAS SELECTED. THE SYSTEM WAS NOT AVAILABLE ON ONSITE AND THE CUSTOMER EMAILED EVENT LOG IMAGE TO THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE). THE EVENT LOG IMAGE CONFIRMED ERROR 32100 AND INDICATED THAT THE ERROR WAS REPORTED BY SOAM-A AND POINTED TO THE EGM YAW BRAKE CURRENT IN THE YAW MOTOR ASSEMBLY. THE TSE RECOMMENDED TO PERFORM AN EMERGENCY POWER OFF (EPO) OF THE PATIENT SIDE CART (PSC), BUT THE ERROR PERSISTED. THE CUSTOMER STATED THAT THEY WERE GOING TO ATTEMPT TO CONVERT THE PROCEDURE TO MULTIPORT, USING THEIR XI SYSTEM. THE PROCEDURE WAS CONVERTED FROM A SINGLE-PORT SYSTEM TO AN XI DA VINCI SYSTEM. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

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.

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 RECURRENT FAULT STATE OCCURRED DURING INITIAL SYSTEM REGISTRATION OF THE MONARCH BRONCHOSCOPY SYSTEM, PREVENTING THE USE OF THE SYSTEM. THE DIAGNOSTIC PROCEDURE WAS ABORTED. THE PATIENT HAD ALREADY BEEN ANESTHETIZED. 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: PROCEDURE WAS A PREOP CT T9 TO THE PELVIS. THE CASE WAS STAGED WITH THREE LEVELS OF LATERAL FROM L1-L4 COMPLETED THE DAY PRIOR, A PREOP CT TAKEN AND THEN AN ALIF AT 5-1 THE DAY OF THE POSTERIOR PORTION. AFTER THE ALIF, PATIENT WAS FLIPPED, AND A SMALL SKIN LEVEL INCISION WAS MADE FROM T9 TO THE PELVIS - NOT MUCH EXPOSURE WAS PERFORMED AS THE SCREWS WERE GOING TO BE INSERTED USING CREO MIS. FLOURO IMAGES WERE ACQUIRED, AND THE MERGE WAS ACCURATE AT ALL LEVELS EXCEPT FOR L4. NEW IMAGES WERE ACQUIRED, AND THE MERGE WAS RERUN WHICH IMPROVED AT L4. WE BEGAN INSERTING SCREWS AT T9 AND SNAKED DOWN TO THE PELVIS. IN THE PELVIS WE WERE GOING TO BE PLACING TWO CREO S2AI SCREWS AND TWO MEDIAL TO LATERAL SI LOK SELECT SCREWS. THE ORDER IN WHICH THEY WERE PLACED WAS CREO S2AI LEFT, SILOK SELECT LEFT, CREO S2AI RIGHT, SILOK SELECT RIGHT - DUE TO THE DRB BEING PLACED IN RIGHT PSIS ON LOW PROFILE QUATTRO SPIKE. FLOURO IMAGES WERE TAKEN, AND ALL THE SCREWS SEEMED TO BE PLACED CORRECTLY. DR. (B)(6) THEN PROCEEDED TO DROP THE RODS AND AFTER THIS WAS COMPLETED, WE ACQUIRED TWO O ARM SPINS TO CHECK ALL OF THE INSTRUMENTATION. AFTER REVIEW OF SCANS, ALL SCREWS WERE PLACED ACCURATELY EXCEPT FOR S2AI ON T

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS AN INTRAOP CASE WITH ZIEHM 3D, SOFTWARE 1.1R3. THE SCAN WAS TRANSFERRED WITH THE USB, UNFORTUNATELY, WE DIDN'T GET AUTOMATIC REGISTRATION AND DID IT MANUALLY. THE ANATOMICAL LANDMARK CHECK HAD BEEN DONE. THE ACCURACY WAS GOOD. THE FIRST SCREW L5-L WAS PLACED WITH GOOD NAVIGATION ACCURACY. BY THE SECOND SCREW L5-R, EE WAS ON THE TRAJECTORY, WITH A GREEN BORDER AND OFFSET. UNFORTUNATELY, WE COULD NOT SEE THE HIGH-SPEED DRILL INSIDE THE EE. THE TOOL WAS VISIBLE TO THE CAMERA OUTSIDE THE EE. THE SURGEON CHECKED THE NAVY ACCURACY, IT WAS NOT ACCURATE ANYMORE. THE SURGEON PLACED THE SCREWS IN THE TRADITIONAL WAY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BLADE WAS BROKEN. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED IN THE SAME PROCEDURE. THE CUSTOMER USED A SPARE INSTRUMENT TO PROCEED WITH THE PROCEDURE.

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, A PNEUMOTHORAX WAS NOTED ON THE PATIENT¿S POST PROCEDURAL X-RAYS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS ASYMPTOMATIC. NO ADDITIONAL INTERVENTION WAS NECESSARY, AND THE PATIENT WAS DISCHARGED ONE (1) DAY LATER. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ADVERSE EVENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER CYSTECTOMY PROCEDURE, THE HARMONIC ACE INSTRUMENT CLAMP CRACKED OPEN 8 MINUTES INTO THE PROCEDURE. THE BROKEN OFF INSTRUMENT FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE INSTRUMENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS WE ATTEMPTED TO SEND THE CT SCAN, WE GOT A "CAMERA DISCONNECTED ERROR," EVEN THOUGH CAMERA WAS PLUGGED IN. WE ALSO GOT A "UAIB VERSION OUTDATED ERROR" MESSAGE WHILE TRYING TO RECEIVE A SCAN. THE CAMERA THEN STOPPED BEING ABLE TO PICK UP END EFFECTOR ON THE VERIFY PAGE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A PLANNED DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AFTER DOCKING DUE TO THE LEFT EYE ON A 0-DEGREE ENDOSCOPE BEING BLURRY. THE CUSTOMER TRIED TO TROUBLESHOOT BY REPLACING THE ENDOSCOPE, BUT THE IMAGE WAS STILL BLURRED. THE TSE HAD THE CUSTOMER POWER CYCLE AND HARD CYCLE THE VISION SIDE CART (VSC) BUT THE IMAGE WAS STILL NOT COMING UP NORMALLY. THE TSE HAD THE CUSTOMER VERIFY THE IMAGE WAS BAD ON THE VSC AS WELL AS ON THE SURGEON SIDE CART (SSC). THE SURGEON OPTED TO CANCEL THE CASE. THERE WAS NO REPORT OF PATIENT HARM DUE TO THIS EVENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PATIENT WAS FINE. THERE WERE NO COMPLICATIONS OR PATIENT INJURY POST-ANESTHESIA. THEY JUST HAD TO WAKE UP THE PATIENT AS THERE WAS NO SCOPE TO USE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL PANCREATECTOMY SURGICAL PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ALLEGED INACCURACY. THE SITE WAS OPERATING FROM T12 TO PELVIS AND THE SURGEON BELIEVED THE RIGHT L2 SCREW WAS APPROXIMATELY 2-3 MM MEDIAL FROM THE PLAN. THE SURGEON TOOK THE SCREW OUT AND REPLACED IT FREE HANDED. THEY WERE THEN ABLE TO CONTINUE ON WITH THE SURGERY. THE PATIENT REPORTED SOME NUMBNESS IN THEIR LEG. THERE WAS A 15 MINUTE DELAY TO THE PROCEDURE. THE PATIENT WAS AFFECTED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS WAS A L4-S1 PERC WITH SCREWS BACKING UP AN OLIF. THEY FLIPPED PATIENT FROM LATERAL TO PRONE AND THEN DID A E3D SPIN. NO ISSUES WITH THE SPIN, HOWEVER THE IMAGE QUALITY WASN'T GREAT AND MADE IT DIFFICULT TO SEE ANATOMY. RUSSELL AND THE PA PLANNED THE INITIAL SCREW TRAJECTORIES AND THEN DR. WILLIAMS CAME OVER AND MADE FINAL ADJUSTMENTS TO THE PLAN. HE STARTED WITH L4-LEFT, THEN HE PLACE L4-RIGHT. HE THEN PLACED L5-RIGHT, HE NOTICED THAT THE MIS TOWER WAS SIGNIFICANTLY LOWER THAN HIS L4-RIGHT TOWER. HE OBTAINED A GREEN CHECK MARK FOR ALL OF HIS SCREWS AND DID NOT GIVE ANY EXTRA ROTATIONS AFTER THE GREEN CHECK MARK. WE WERE NOT SURE WHY THIS WAS THE CASE. BEFORE PROCEEDING, WE WENT AND LOOKED AT THE PLAN AND THE PLAN SHOWED THAT 4 AND 5 SHOULD HAVE HAD THE SAME HEIGHT AND DEPTH. ONCE ALL THE SCREWS WERE PLACED, WE TOOK CONFIRMATION SHOTS WITH THE C-ARM. DR. WILLIAMS THEN POINTED OUT TO US THAT THE L5-RIGHT SCREW WAS ABOUT A CM LOWER THAN L4. HE THEN BACKED OUT THE L5 SCREW TO BE MORE IN LINE WITH HIS L4 SCREW. HE PLACED 6 SCREWS IN TOTAL AND 5 OF THE 6 SEEMED TO BE AT THE APPROPRIATE HEIGHT/DEPTH. DR. WILLIAMS WANTS TO KNOW WHY THE L5-RIGHT SCREW WAS PLACED LOWER THAN WHAT HIS PLA

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 AFTER A SURGERY ON (B)(6) 2023 UTILIZING THE EXCELSUS GPS THE PATIENT EXPERIENCED EXTREME PAIN AND DECREASED MOVEMENT IN THEIR LEGS. ON (B)(6) 2023 MRI SCANS REVEALED A COMPRESSION FRACTURE OF T10. REVISION WAS PERFORMED URGENTLY TO DECOMPRESS THE SITE AND REVISE THE HARDWARE SURROUNDING IT.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SITE WERE UNABLE TO COMPLETE THE REGISTRATION OF THE PATIENT FROM L3 TO S1. THE SITE WERE WORKING WITH A PRE-OP CT SCAN AND PLACED TWO TITANIUM CAGES FROM L4 TO L5 AND L5 TO S1. THEY HAD ALSO PLACED A PELVIC BOLT IN S2. THE MANUFACTURER REPRESENTATIVE SAID THAT THE PELVIC BOLT WAS COVERING THE S1 BODY IN THE OBLIQUE SHOT, BUT DID NOT THINK THE INABILITY TO PERFORM THE REGISTRATION WAS DUE TO THE PELVIC BOLT, BUT THOUGHT THE TITANIUM CAGES MAY HAVE BEEN THE ROOT CAUSE OF THE ISSUE. THE GUIDANCE SYSTEM WAS ABORTED, AS THE SURGEON RESORTED TO THE NAVIGATION SYSTEM. THE DELAY WAS 1 HOUR. THE PATIENT'S BLOOD LOSS WAS INCREASED AND THE PATIENT NEEDED SEVERAL BLOOD TRANSFUSIONS BECAUSE OF THE DELAY. PATIENTS RECOVERY MAY BE AFFECTED, BUT THEIR OUTCOME WILL BE THE SAME.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT WAS DAMAGED AND THE COVER WAS TORN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. AN INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUE. THE INSTRUMENT WAS COLLIDED WITH THE MONOPOLAR CURVED SCISSORS INSTRUMENT, AND THE PLASTIC WRIST COVER AND THE PLASTIC PART OF THE TIP WERE BROKEN AFTER THE COLLISION. THE FRAGMENT DID NOT FALL INSIDE THE PATIENT¿S ANATOMY. POST-OPERATIVE TESTS (X-RAY AND ULTRASOUND) WERE PERFORMED. THE PATIENT DID NOT RETURN TO THE HOSPITAL FOR ANY POST-SURGICAL COMPLICATIONS. THE PROCEDURE WAS DELAYED FOR TEN MINUTES. THE SYNCHROSEAL INSTRUMENT AND THE PLASTIC OVERMOLD WERE DISCARDED AND WILL NOT BE RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPLAINANT, (B)(6) REPORTED THAT THE PATIENT UNDERWENT TOTAL MESORECTAL EXCISION ON (B)(6) 2023. ON (B)(6) 2023 THE PATIENT COMPLAINED OF FEVER, GENERAL DISCOMFORT, AND WEAKNESS. A DIGITAL EXAMINATION CONFIRMED THAT THE ANASTOMOSIS WAS NORMAL. AS FEVER WAS 39.5 AND SUDDEN, IN ORDER TO BE SURE THAT THERE WAS NO ISCHEMIC CHANGES IN THE COLON WHICH WAS BROUGHT TO SMALL PELVIS FOR COLO-ANAL ANASTOMOSIS, FLEXIBLE PROCTOSCOPY WAS DONE. IT REVEALED NECROTIC DISTAL COLON (APPROX. 5-10 CM) ABOVE ANASTOMOSIS. AN URGENT LAPAROTOMY WAS PERFORMED: THE COLON WAS BROUGHT FROM SMALL PELVIS, RESECTED, AND TERMINAL COLOSTOMY WAS DONE SAME DAY. ANUS (VERY SHORT RECTAL STUMP) WAS CLOSED WITH PURSESTRING SUTURE. THE SURGICAL FOLLOW-UP WAS UNEVENTFUL, BUT DUE TO URINARY RETENTION ON (B)(6) 2023 AN EPICYSTOSTOMY WAS PERFORMED FOR A DATE OF RESOLUTION ON (B)(6) 2023. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE. THE EVENT OCCURRED ON (B)(6) -2023 AND ASENSUS SURGICAL WAS MADE AWARE ON 08-SEPTEMBER-2023.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED EXTENDED TOTALLY EXTRAPERITONEAL (ETEP) INCISIONAL HERNIA REPAIR PROCEDURE, THE PATIENT EXPERIENCED A CONVERSION TO OPEN AND A SUBSEQUENT SURGICAL PROCEDURE. THE ISSUE OCCURRED INITIALLY WHEN THE SYSTEM ENCOUNTERED A RECOVERABLE FAULT RELATED TO ARM 3. THE FAULT WITH ERROR CODE 23025 REPEATED ITSELF AS SOON AS RECOVERY WAS ATTEMPTED. THE TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE LIVE LOGS AND VERIFIED SEVERAL INSTANCES OF ERROR CODE 23025, INDICATING AXIS 1 ON RIGHT MASTER TOOL MANIPULATOR (MTMR). THE SURGEON SWITCHED HAND CONTROL ASSIGNMENTS WITH ARM 3 BEING CONTROLLED BY THE LEFT MASTER TOOL MANIPULATOR (MTML) AND MTMR CONTROLLING ARM 1 TO RULE OUT ANY ARM ISSUES. THE FAULT RETURNED AND WAS STILL POINTING AT THE MTMR. THE SYSTEM WAS THEN POWER CYCLED, WHICH DID NOT RESOLVE THE ISSUE. THE MTMR WAS PUT THROUGH AN EXERCISING MOVEMENT AND A HARD POWER CYCLE WAS PERFORMED WITH THE EMERGENCY POWER OFF (EPO) OF THE SYSTEM, BUT THIS ALSO DID NOT RESOLVE THE ISSUE. THE SURGEON MADE THE CLINICAL DECISION TO OPEN DUE TO THE MTMR BEING INOPERABLE. THE PATIENT TOLERATED THE OPEN PROCEDURE. HOWEVER, POST-OPERATIVELY, THE PATIENT HAD A WOUND R

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED URETERAL REIMPLANTATION SURGICAL PROCEDURE THAT PATIENT SIDE MANIPULATOR (PSM) 3 WAS NOT ACCEPTING THE DRAPE. THE SITE TRIED RESEATING THE DRAPE MULTIPLE TIMES. A 30900 ERROR ALSO OCCURRED. THE SITE CHECKED TO ENSURE THAT THE DRAPE WAS EVEN, AND NO PART OF THE DRAPE WAS UNDERNEATH THE STERILE ADAPTOR. THE CUSTOMER RE-DRAPED THE SYSTEM, WITH NO CHANGE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER EMERGENCY POWER OFF (EPO), AND POWER CYCLE THE SYSTEM, WITH NO CHANGE. THE CUSTOMER ELECTED TO CONVERT THE PROCEDURE FROM THE SINGLE-PORT SYSTEM TO THEIR XI SYSTEM. THERE WERE NO REPORTS OF PATIENT INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THERE WERE NO ERRORS OBSERVED BY THE CUSTOMER. THE DELAY WAS ROUGHLY ONE HOUR.

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE EGPS UNIT WILL NOT POWER ON. EITHER THE POWER CABLE OR WHERE IT CONNECTS TO THE UNIT IS DAMAGED. A CASE COULD NOT BE PERFORMED WITH THE ROBOT TODAY BECAUSE OF THE ISSUE. IT HAD TO BE COMPLETED UNDER 2D FLUORO WITHOUT THE EGPS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED, ¿LEARNING CURVE FOR SINGLE-PORT ROBOT-ASSISTED RECTAL CANCER SURGERY¿, THE FOLLOWING EVENTS WERE REPORTED. FROM APRIL 2019 TO OCTOBER 2019, 57 SINGLE-PORT ROBOTIC (SPR)-ASSISTED RECTAL CANCER SURGERIES PERFORMED BY ONE SURGEON WERE INCLUDED IN THE STUDY. A TOTAL OF 57 PATIENTS (34 MALES, 59.6%) WERE TREATED FOR RECTAL CANCER AND INCLUDED 34 LOW ANTERIOR RESECTION(LAR) (59.6%), 14 ULTRA-LAR (24.6%), 7 INTERSPHINCTERIC RESECTION (ISR) (12.3%), AND 2 APR (ABDOMINOPERINEAL RESECTION) (3.5%) CASES. AMONG THESE, 11 PATIENTS ADDITIONALLY UNDERWENT ROBOTIC TRANSANAL TOTAL MESORECTAL EXCISION (TATME). THE MEAN AGE OF THE PATIENTS WAS 57.4 ± 10.1 YEARS, THE MEAN BMI WAS 24.5 ± 3.5 KG/M2, AND THE MEDIAN AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) PHYSICAL STATUS (PS) CLASSIFICATION WAS II. THE MEAN VALUE OF TOTAL OPERATION TIME (OT) WAS 241.8 ± 91.7 MINUTES. THE MEAN ESTIMATED BLOOD LOSS (EBL) WAS 158.4 ± 103.3ML. A TOTAL OF 23 COMPLICATIONS WERE IDENTIFIED IN THE PATIENTS WHO UNDERWENT SURGERY WHICH INCLUDES POSTOPERATIVE ILEUS, POSTOPERATIVE BLEEDING, CHYLOUS DRAIN COLOR CHANGE, AND URINARY RETENTIO

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, A PNEUMOTHORAX AND PNEUMOMEDIASTINUM WERE NOTED POST-PROCEDURE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PNEUMOTHORAX AND PNEUMOMEDIASTINUM RESOLVED AND THE PATIENT WAS DISCHARGED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE DOCTOR INSERTED HIS LAST SCREW THEN CAPTURED FLUORO SHOTS. FLUORO AND STIMMING THE SCREW PROVED IT WAS INFERIOR OF THE PLANNED POSITION. THE DOCTOR REMOVED THE SCREW AND THEN RE-IMPLANTED IT WITH A JAMSHID-K-WIRE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT CAMERA DISPLAYED HARDWARE BUMP PERFORMED MERGE VERIFIED ALL INSTRUMENTS INCLUDING EE. SUCCESSFUL MERGE, WHEN WE WENT TO PLACE IMPLANTS, SURGEON WAS UNABLE TO SELECT LEVEL AND GUIDE ROBOT TRAJECTORY. SURGEON ABORTED ROBOT PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE GEAR/CABLE MECHANISM OF THE FENESTRATED FORCE BIPOLAR BROKE WHILE GRASPING THE STOMACH. THE INSTRUMENT COULD NOT BE OPENED (WITH HELP OF INTUITIVE SUPPORT - WOULD NOT OPEN W/IRK) SO THE STOMACH WAS FORCIBLY REMOVED WHICH CAUSED A LARGE HOLE IN THE STOMACH. STOMACH REPAIRED IN 2 LAYERS, LEAK TEST ON EGD WAS NEGATIVE. UNABLE TO COMPLETE THE PARAOESOPHAGEAL HERNIA REPAIR AS PLANNED - PERFORMED GASTROPEXY INSTEAD.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HAD A GOOD MERGE WITH 0 SHIFTS. WHEN LANDING END EFFECTOR ON TRAJECTORY THE INSTRUMENTS ON THE SCREEN WERE NOT MATCHING WHAT THE WE WERE SEEING LIVE ON THE PATIENT. REIMAGED THE PATIENT AND STILL HAD NO SHIFT. NAV STILL LOOKED OFF AT THE TOP OF THE CONSTRUCT BUT DEAD ON LOWER SCREWS. STILL MISSED OUR L5 RIGHT SCREW. SENDING LOGS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THE LEFT EYE IN THE SURGEON SIDE CART (SSC) WAS NOT WORKING. THE TSE WAS UNABLE TO VIEW THE LIVE LOGS. THE TSE WALKED THE CUSTOMER THROUGH A SYSTEM POWER CYCLE AND A HARD POWER CYCLE OF THE SSC, BUT THE LEFT EYE IMAGE WAS STILL NOT PRESENT. THE TE HAD THE CUSTOMER VERIFY THE FIBER CABLING HAD BLUE LED AT BOTH ENDS AND IT WAS BLUE. THE CUSTOMER WAS UNSURE HOW THEY WOULD PROCEED WITH THE CASE AND WERE ACTIVELY SEARCHING FOR ANOTHER SYSTEM TO UTILIZE. THE CALL ENDED AND THE TSE WAS UNABLE TO TROUBLESHOOT FURTHER. THE PROCEDURE WAS COMPLETION UNKNOWN WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE OR DIRECTOR INFORMED THERE WAS NO HARM TO THE PATIENT IDENTIFIED EXCEPT PROLONGED ANESTHESIA EXPOSURE SINCE WE HAD TO CONVERT TO MULTIPORT. THE CASE WAS CONVERTED TO MULTIPORT FROM A SINGLE PORT SYSTEM. THE CUSTOMER WILL NOT BE DISCLOSING ANY PATIENT INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HAD A GOOD MERGE WITH 0 SHIFTS. WHEN LANDING END EFFECTOR ON TRAJECTORY THE INSTRUMENTS ON THE SCREEN WERE NOT MATCHING WHAT THE WE WERE SEEING LIVE ON THE PATIENT. REIMAGED THE PATIENT AND STILL HAD NO SHIFT. NAV STILL LOOKED OFF AT THE TOP OF THE CONSTRUCT BUT DEAD ON LOWER SCREWS. STILL MISSED OUR L5 RIGHT SCREW. SENDING LOGS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED, ¿A SINGLE-CENTER EXPERIENCE OF OVER 300 CASES OF SINGLE-INCISION ROBOTIC CHOLECYSTECTOMY COMPARING THE DA VINCI SP WITH THE SI/XI SYSTEMS¿, THE FOLLOWING EVENTS WERE REPORTED. A RETROSPECTIVE REVIEW OF PATIENTS WHO UNDERWENT SINGLE-INCISION ROBOTIC CHOLECYSTECTOMY BETWEEN (B)(6) 2014 AND (B)(6) 2021 AT A SINGLE CENTER WERE INCLUDED IN THE STUDY. IN TOTAL, 334 PATIENTS UNDERWENT SINGLE-INCISION ROBOTIC CHOLECYSTECTOMIES, WITH 118 PATIENTS USING SI/XI SYSTEM AND 216 PATIENTS USING SINGLE PORT (SP). OF THE 216 PATIENTS THAT UNDERWENT SP SURGERIES, TWO PATIENTS IN THE SP GROUP CONVERTED TO MULTIPORT LAPAROSCOPIC SURGERIES. THE CONVERSION WAS DUE TO ONE OF THE PATIENTS HAD ACUTE CHOLECYSTITIS AND THE OTHER HAD SEVERE ADHESIONS FROM PREVIOUS UPPER ABDOMINAL SURGERY. THERE WERE NO INTRAOPERATIVE COMPLICATIONS, SUCH AS MASSIVE BLEEDING OR BILE DUCT INJURIES. SEVEN PATIENTS WERE OBSERVED WITH ACUTE INFLAMMATION INTRA-OPERATIVELY. THE ESTIMATED BLOOD LOSS FOR ALL PATIENTS WAS < 50ML, EXCEPT FOR THE CASES THAT REQUIRED CONVERSION TO LAPAROSCOPIC SURGERIES. THE RATE OF POST-OPERATIVE COMPLICATIONS IN S

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IDENTIFIED AS L1-L3 BY SURGEON, REP, AND CSR. CENTROIDS WERE PLACED ON THE L1-L3 LEVELS AND A MERGE WAS RUN. THE SURGEON, REP, AND CSR REVIEWED THE MERGE AND VERIFIED THE LEVELS TOGETHER. FOLLOWING PLACEMENT OF SCREWS AT L1, SURGEON NOTED NAVIGATION WAS NO LONGER ACCURATE. WE REIMAGED THE PATIENT BEFORE PLACING SCREWS AT L3. FLUORO WAS USED TO CONFIRM SCREW PLACEMENT, BUT IT WAS NOTED THAT THE RIGHT L3 SCREW WAS MEDIAL TO WHAT WAS PLAN. THE SCREW STIMULATED AT 9MA, PER NEUROMONITORING TECH. THE SURGEON REMOVED THE SCREW AND DECIDED TO REPLACE IT FREEHAND USING FLUORO ASSISTANCE. ALL SCREW PLACEMENT WAS CONFIRMED WITH FINAL FLUORO IMAGES.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER THE SCREWS WERE PLACED, ALL OF THE LUMBAR SCREWS AND S2AIS LOOKED GOOD ON THE IMAGES, BUT WE NOTICED THAT ALL OUR SILOK SCREWS LOOKED LIKE THEY WERE BURIED TOO DEEP.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: T. AKAZAWA, Y. TORII, J. UENO ET AL., SAFETY OF ROBOTIC-ASSISTED SCREW PLACEMENT FOR SPINE SURGERY: EXPERIENCE FROM THE INITIAL 125 CASES, JOURNAL OF ORTHOPAEDIC SCIENCE, HTTPS://DOI.ORG/10.1016/J.JOS.2023.06.003 SUMMARY: THE PRESENT STUDY AIMED TO EVALUATE THE SAFETY OF ROBOT-ASSISTED SCREW PLACEMENT IN 125 CASES AFTER INTRODUCING A SPINAL ROBOTICS SYSTEM AND TO IDENTIFY THE SITUATIONS WHERE DEVIATION WAS LIKELY TO OCCUR. THE SUBJECTS WERE 125 CONSECUTIVE PATIENTS WHO UNDERWENT ROBOTIC-ASSISTED SCREW PLACEMENT USING A SPINAL ROBOTICS SYSTEM (MAZOR X STEALTH EDITION, MEDTRONIC) FROM APRIL 2021 TO JANUARY 2023. THE 1048 SCREWS PLACED WITH ROBOTIC ASSISTANCE WERE EVALUATED. WE INVESTIGATED INTRAOPERATIVE ADVERSE EVENTS OF THE ROBOTICS SYSTEM AND COMPLICATIONS OCCURRING WITHIN 30 DAYS AFTER SURGERY. WE EVALUATED SCREW ACCURACY AND DEVIATION AND COMPARED THEM FOR VERTEBRAL LEVELS, SCREW INSERTION METHODS (OPEN TRADITIONAL PEDICLE SCREW [OPEN-PS], CORTICAL BONE TRAJECTORY SCREW [CBT], PERCUTANEOUS PEDICLE SCREW [PPS], AND S2 ALAR ILIAC SCREW [S2AIS]), DIAGNOSIS, AND PHASES OF SURGICAL CASES. THE DEVIATION RATE OF ROBOTIC-ASSISTED SCREW PLACEMENT FOR SPINE SURGERY WAS 2.2%. COMPLICATIONS

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 INTRAOP (O-ARM) L4-L5 TLIF EXTENSION OF EXISTING L5-S1 TLIF WITH REMOVAL OF L5-S1 SCREWS AND RODS. INTRAOP WITH CREO 5.5 SCREWS. FIRST DR (B)(6) OPENED UP THE PATIENT AND REMOVED THE EXISTING MATERIAL, THEN PLACED DRB AND SM ON PSIS. SM WAS ACTIVATED, SCOUT SHOTS WERE TAKEN, APNEA WAS INITIATED, SNAPSHOT AND SCAN WERE TAKEN. DURING SCAN TRANSFER, ANEA WAS APPLIED ONCE MORE. NOTHING WAS MOVED BEFORE THE SCAN WAS AUTO REGISTERED. DRB SHIFT WAS SHOWN WHILE TRANSLATING THE OR TABLE OUT OF THE O-ARM LUMEN BUT DISAPPEARED ONCE PATIENT WAS FULLY BACKED OUT AND SM TURNED GREEN. SCREW PLANNING WAS DONE (PEDICULE SCREWS). WE NOTICED THAT TWO "TRAJECTORIES" WERE HIGHLIGHTED IN THE 3D VIEW. WHEN MOVING THE ROBOT TO THE OR TABLE, THE CAMERA WENT DEAD. THE CAMERA COULD NOT SEE ANYTHING ANYMORE (NO DRB, NO EE, NO INSTRUMENTS) AND THE ARM MOVEMENT WAS FROZEN. THE ARM COULD NOT BE MOVED, NEITHER BY THE BUTTONS ON THE CP, NEITHER BY THE FOOTSWITCH OR BRACELET. I SWITCHED TO CRANIAL AND BACK, WHICH UNLOCKED THE CAMERA AND THE ARM MOVEMENT. WHEN DRILLING FIRST SCREW DEFLECTION WAS NOTICED, BUT DRILLED TRAJECTORY WAS COMPLETELY LATERAL OF THE PLANNED ONE (VERIFIED WITH FEELER). SURGEON

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE DOING AN INTRAOPERATIVE WORKFLOW, WERE ABLE TO SUCCESSFULLY DO A SPIN BUT NAVIGATION WAS OFF BY APPROXIMATELY 5 MM IN THE SUPERIOR DIRECTION AND A SCREW WAS MISPLACED. THEY THEN DECIDED TO RESIGN BUT UPON REBOOT E3D REQUIRED A FULL REHOMING. AFTER A FULL REHOMING THEY DID ANOTHER SPIN AND NAVIGATION WAS ACCURATE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FUSES NEED REPLACING FOR EXCELSIUS GPS.