ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY, THE CASE WAS ABORTED AND THEN FREE HANDED TO PLACE SCREWS.

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE SAW BLADE DETACHED FROM SAW HAND PIECE WHILE CUTTING FEMUR, SAW BLADE STAYED EMBEDDED IN THE FEMUR. BLACK LIQUID WAS NOTED AROUND WHERE THE SAW BLADE ATTACHES TO THE SAW HAND PIECE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 5.

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 BLADE OF THE HARMONIC ACE INSTRUMENT FRACTURED AS THE INSTRUMENT WAS ACTIVATED. THE SURGEON CLAIMED THAT HE DID NOT TOUCH ANY HARD OBJECTS WITH THE INSTRUMENT. THE FRACTURED PIECE FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED.

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

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT PRIOR TO A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, THE ROBOTIC-ASSISTED SOLUTION SAW HANDPIECE DEVICE WAS OPENED FOR THE PROCEDURE PRIOR TO THE PATIENT COMING INTO THE ROOM. THE DEVICE HAD A LEAK WHICH APPEARED TO BE OIL. IT WAS REPORTED THAT THE SAME WAS TRUE WITH THE SECOND HANDPIECE. THE HANDPIECES WERE RETURNED TO STERILE PROCESSING FOR CLEANING AND STERILIZATION. WHEN IN STERILE PROCESSING THE DEVICE WAS HAND WASHED AND IT WAS MADE SURE THAT ALL RESIDUE WAS REMOVED FROM BOTH HANDPIECES AND RE-STERILIZED. AFTER THE STERILIZED PACKAGES WERE RE-OPENED, THE OIL RE-APPEARED AND THE CASE HAD TO BE CANCELLED. IT WAS REPORTED THAT THE PATIENT RECEIVED A REGIONAL ANESTHETIC PRIOR TO THE PROCEDURE BEING CANCELLED. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

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

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT PRIOR TO A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, THE ROBOTIC-ASSISTED SOLUTION SAW HANDPIECE DEVICE WAS OPENED FOR THE PROCEDURE PRIOR TO THE PATIENT COMING INTO THE ROOM. THE DEVICE HAD A LEAK WHICH APPEARED TO BE OIL. IT WAS REPORTED THAT THE SAME WAS TRUE WITH THE SECOND HANDPIECE. THE HANDPIECES WERE RETURNED TO STERILE PROCESSING FOR CLEANING AND STERILIZATION. WHEN IN STERILE PROCESSING THE DEVICE WAS HAND WASHED AND IT WAS MADE SURE THAT ALL RESIDUE WAS REMOVED FROM BOTH HANDPIECES AND RE-STERILIZED. AFTER THE STERILIZED PACKAGES WERE RE-OPENED, THE OIL RE-APPEARED AND THE CASE HAD TO BE CANCELLED. IT WAS REPORTED THAT THE PATIENT RECEIVED A REGIONAL ANESTHETIC PRIOR TO THE PROCEDURE BEING CANCELLED. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. THIS IS REPORT 1 OF 2 FOR (B)(4).

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative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

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 SP (SINGLE-PORT) PROSTATECTOMY PROCEDURE, AN ARM WAS NOT ACCEPTING STERILE ADAPTERS. THE STERILE ADAPTERS KEPT POPPING OFF ARM #3. AS A RESULT, THE CUSTOMER ELECTED TO CONVERT THE SURGICAL PROCEDURE TO A MULTI-PORT DA VINCI-ASSISTED PROSTATECTOMY 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER HAD UNSPECIFIED PROBLEMS WITH A HARMONIC ACE INSTRUMENT. A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT AND IT WAS UNKNOWN IF IT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

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.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE REMOVAL OF THE NAIL WAS AN ADDITIONAL 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.

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.

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 A PATIENT UNDERWENT A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) AND WAS ENROLLED IN A CLINICAL STUDY. THE PROCEDURE WAS COMPLETED WITH NO INTRA-OPERATIVE COMPLICATIONS. NO DEVICE MALFUNCTIONS WERE REPORTED. THE PATIENT WAS FOUND WITH AN INCISION SITE INFECTION EIGHT DAYS POST-OPERATIVELY AND DRAINAGE WAS PERFORMED. THERE WAS NO MENTION OF OTHER MEDICAL INTERVENTION OR MEDICATION GIVEN FOR THE INFECTION. THE PATIENT WAS DISCHARGED HOME THREE WEEKS AFTER THE PROCEDURE, BUT UNKNOWN IF THE INFECTION PROLONGED THE HOSPITALIZATION.

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 PROSTATECTOMY SINGLE-PORT (SP) SURGICAL PROCEDURE, THE SYSTEM DISPLAYED A MESSAGE INDICATING THAT THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) WAS NOT CONNECTED AND HAD A DIRTY FIBER CABLE MESSAGE. THE CUSTOMER CHECKED THE CABLE CONNECTIONS TO THE IESU, SURGEON SIDE CONSOLES (SSC) AND THE PATIENT SIDE CART (PSC) PRIOR TO CALLING IN THE ISSUE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND NOTED A 307 ERROR POINTING TO THE VIDEO PROCESSOR (VP). THE TSE HAD THE CUSTOMER POWER OFF THE SYSTEM AND ENSURE THAT THE FIBER CABLES WERE FULLY SEATED ON THE BACK OF THE CORE AND VP, RESEAT THE ORANGE FIBER CABLES, AND ENSURE THAT THE BREAKERS OF THE VP AND ENDOSCOPE CONTROLLER (EC) WERE ON. THE SYSTEM POWERED ON WITH NO OTHER ERRORS, BUT LATER THE ERRORS RETURNED. THE TSE HAD THE CUSTOMER POWER CYCLE THE COMPONENTS AGAIN AND RESEAT THE FIBER CABLES. THE VP FAULTED AGAIN AND INDICATED A RED FIBER CABLE STATUS ON THE CORE TO THE VP. THE CUSTOMER USED A FIBER CABLE FROM THE SIMULATOR AND THE ERRORS CLEARED AGAIN. THE CUSTOMER THEN CALLED LATER AND REPORTED THAT THE VP FAULT RETURNED AS A N

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.

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 UNILATERAL INGUINAL HERNIA REPAIR SURGICAL PROCEDURE, THE SURGEON FELT A SHOCK PULSING SENSATION IN HIS FOOT WHEN PRESSING THE FOOT PEDAL. THE SURGEON REPORTED WHEN HE PRESSED THE COAGULATION PEDAL, AN IMMEDIATE INTENSE PULSATING SHOCK SENSATION FROM HIS RIGHT GREAT TOE TO HIS HIP, WHEN RELEASING THE PEDAL, IT WOULD STOP WITH NO LINGERING SENSATION AT ALL, OCCURRING APPROXIMATELY 4-5 TIMES DURING THE PROCEDURE. (CLOG SLIP-ON SHOES WERE WORN). THE PROCEDURE WAS CONTINUED WITH THE FENESTRATED BIPOLAR FORCEPS AND NOT THE COAGULATION BUTTON FOR THE REMAINDER OF THE PROCEDURE. THERE IS NO INJURY FROM THIS EVENT AND THE PROCEDURE WAS COMPLETED AS PLANNED.

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.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF A CLINICAL ARTICLE WAS CONDUCTED BASED ON A RETROSPECTIVE STUDY EVALUATING THE SAFETY AND FEASIBILITY OF MINIMALLY INVASIVE GASTRECTOMY IN PATIENTS WITH ADVANCED GASTRIC CANCER WHO HAD UNDERGONE PREOPERATIVE CHEMOTHERAPY. THE STUDY, WHICH ANALYZED 150 CASES FROM JANUARY 2009 TO MARCH 2022, FOCUSED ON BOTH DA VINCI ROBOTIC AND LAPAROSCOPIC GASTRECTOMY APPROACHES. THE RESULTS DEMONSTRATED THAT MINIMALLY INVASIVE PROCEDURES, PARTICULARLY ROBOTIC GASTRECTOMY, WERE FEASIBLE AND SAFE, WITH MINIMAL BLOOD LOSS (72 GRAMS) AND MANAGEABLE COMPLICATIONS. NOTABLY, CONVERSION SURGERY WAS PERFORMED IN 41 CASES (27.3%), AND PANCREATIC FISTULA WAS THE MOST COMMON COMPLICATION, OCCURRING IN 11 PATIENTS. POSTOPERATIVE COMPLICATIONS (GRADE > OR = 3A) WERE OBSERVED IN 18 PATIENTS. THE STUDY ACKNOWLEDGED LIMITATIONS, INCLUDING ITS RETROSPECTIVE DESIGN, SMALL SAMPLE SIZE, AND SHORT FOLLOW-UP PERIOD. OVERALL, ROBOTIC GASTRECTOMY SHOWED POTENTIAL FOR IMPROVED SURGICAL SAFETY, ESPECIALLY IN COMPLEX CASES INVOLVING SPLENECTOMY, AND FURTHER INVESTIGATION IS NEEDED TO REFINE TREATMENT STRATEGIES AND ASSESS LONG-TERM OUTCOMES. THE RESEARCHERS DID NOT REPORT ANY SPECIFIC MALFUNCTIONS OR INJURIES RELA

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.

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.

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.

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 HYSTERECTOMY PROCEDURE, A PLASTIC PART OF THE SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE FRAGMENT DURING THE SAME PROCEDURE. THE CUSTOMER USED AN UNSPECIFIED BACKUP INSTRUMENT TO CONTINUE COMPLETING THE PROCEDURE AS PLANNED.

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.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL, INC. (ISI) HAS REVIEWED AN ARTICLE THAT COMPARED THE FEASIBILITY AND SAFETY OF THE REVO-I ROBOT SYSTEM TO DA VINCI SURGICAL SYSTEMS FOR ROBOT-ASSISTED PANCREATICODUODENECTOMIES (RPD) AND THE FOLLOWING COMPLICATIONS WERE MENTIONED: A TOTAL OF 10 PATIENTS UNDERWENT REVO-I ROBOT ASSISTED RPD AND A TOTAL OF 37 PATIENTS UNDERWENT DA VINCI ASSISTED RPD BETWEEN MARCH 2017 AND AUGUST 2020. THERE WAS NO STATISTICAL DIFFERENCE IN THE INTRAOPERATIVE BLOOD LOSS BETWEEN THE TWO GROUPS, BUT THERE WAS ONE CASE OF INTRA-OPERATIVE TRANSFUSION REQUIRED IN THE DA VINCI GROUP. THE DA VINCI GROUP HAD TWO CASES OF CLAVIEN-DINDO GRADE IIIB COMPLICATIONS THAT REQUIRED REOPERATION. ONE PATIENT WAS READMITTED DUE TO INTESTINAL OBSTRUCTION AND UNDERWENT ADHESIOLYSIS AND BYPASS SURGERY, WHILE THE OTHER PATIENT HAD A DRAINAGE CATHETER ISSUE THAT REQUIRED FOREIGN BODY REMOVAL UNDER GENERAL ANESTHESIA. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE POSTOPERATIVE PANCREATIC FISTULA (POPF) RATE BETWEEN THE TWO GROUPS. SEVEN PATIENTS IN THE DA VINCI GROUP WERE READMITTED, INCLUDED THE ONE PATIENT PREVIOUSLY MENTIONED AS REQUIRING REOPERATION, ONE PATIENT WITH EPIGASTRIC DISCOMFORT, AND FIVE PATIENTS

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.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF AN ARTICLE THAT SUMMARIZED THE PRELIMINARY EXPERIENCE OF USING THE DA VINCI SURGICAL SYSTEM FOR ROBOT BREAST SURGERY (RBS) WAS PERFORMED. THE STUDY ANALYZED 151 PATIENTS UNDERGOING RBS BETWEEN SEPTEMBER OF 2022 TO JANUARY OF 2025. A TOTAL OF 40 PATIENTS UNDERWENT BREAST SURGERY USING THE DA VINCI SI SURGICAL SYSTEM AND 137 PATIENTS UNDERWENT BREAST SURGERY USING THE DA VINCI XI SURGICAL SYSTEM. A TOTAL OF 10 PATIENTS EXPERIENCED COMPLICATIONS INCLUDING THE FOLLOWING: 1 PATIENT EXPERIENCED AN INFECTION DUE TO SKIN BURNS AND LOST THE PROSTHESIS, 7 PATIENTS HAD PERIOPERATIVE SKIN REDNESS AND SWELLING WHICH IMPROVED AFTER TOPICAL NITROGLYCERIN OINTMENT WAS ADMINISTERED, AND 2 PATIENTS WERE DISCHARGED FROM THE HOSPITAL WITHOUT DISINFECTION AND DRESSING CHANGE OF THE DRAINAGE TUBE, RESULTING IN THE LOSS OF THE RETROGRADE INFECTION PROSTHESIS. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY INTUITIVE SURGICAL, INC. (ISI) DEVICE. ISI FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THE TIME 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL TONSILLECTOMY SURGICAL PROCEDURE THAT A YELLOW CIRCLE OCCURRED WHEN INSTALLING THE CAMERA. THE CALLER STATED THAT THEY REMOVED THE CAMERA TO PERFORM A CERTAIN PART OF THE CASE, AND WHEN REINSTALLING THE CAMERA IN THE PATIENT SIDE CART (PSC), THE IMAGE HAD A YELLOW CIRCLE. THE INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) FOUND NO RELATED ERRORS IN THE SYSTEM LOGS. THE ISI TSE SUGGESTED TO RESEAT THE STERILE ADAPTER. THE CALLER STATED THEY ALREADY PERFORMED THAT. THE ISI TSE SUGGESTED TO REPLACE THE CAMERA, AND IF NO CHANGE, TO RE-DRAPE OR HARD POWER CYCLE THE SYSTEM. THE CALLER STATED THAT THE SURGEON WAS GOING TO BE DONE WITH THE SYSTEM AND WOULD BE COMPLETING THE CASE MANUALLY. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSTHORACIC ESOPHAGECTOMY - CHEST ANASTOMOSIS SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS FOUND TO HAVE A BROKEN TIP. THE CUSTOMER USED A SPARE INSTRUMENT TO CONTINUE WITH THE PROCEDURE. A FRAGMENT FROM THE INSTRUMENT REPORTEDLY FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT FUNCTIONALITY WAS INSPECTED BEFORE USE WITH NOTHING FOUND OUT OF THE ORDINARY. THE EVENT OCCURRED WHILE THE SURGEON WAS DISSECTING AND AFTER ACTIVATING THE HARMONIC ACE INSTRUMENT TO ONCE. THE SURGEON DID NOT NOTICE FUNCTIONALITY ISSUES DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL. THE INSTRUMENT WAS NOT REMOVED BEFORE BRAKEAGE. THE WRIST WAS STRAIGHTENED. THE STAFF DID NOT FEEL RESISTANCE DURING REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE NOTED TO THE CANNULA. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED VISUALLY IN THE SAME PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURES WERE DONE TO REMOVE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 02/26/2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5151229 STATING: "SMALL SCREW FROM DAVINCI SYNCHROSEAL FELL OFF INSIDE PATIENT. SURGEON REMOVED SCREW IMMEDIATELY. DAVINCI REP MADE AWARE. DEVICE REMOVED FROM THE FIELD."

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.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT WHO WAS ENROLLED IN A CLINICAL STUDY UNDERWENT A DA VINCI ASSISTED LOW ANTERIOR RESECTION WHICH A TEMPORARY ILEOSTOMY WAS PLACED IN THE LOWER RIGHT ABDOMEN. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED DA VINCI DEVICE MALFUNCTIONS OR ANY COMPLICATIONS. NO SIGNS OR SYMPTOMS OF BOWEL OBSTRUCTIONS HAVE BEEN REPORTED. THE PATIENT WAS FOUND WITH NARROWING OF THE ANUS THREE MONTHS LATER, AND AN OUTPATIENT PROCEDURE WAS PERFORMED. TWO MONTHS LATER, THE PATIENT WAS SCHEDULED FOR AN ILEOSTOMY TAKEDOWN BUT WAS FOUND WITH ANASTOMOSIS SITE NARROWING FROM THE PRE-PROCEDURAL COLOSCOPY. A SPHINCTEROTOMY WAS PERFORMED FOR THE ANAL STENOSIS ON AND THE PATIENT HAS BEEN REPORTED AS DOING WELL POST-PROCEDURALLY. THE STUDY INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DA VINCI DEVICES NOR THE 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: IT WAS REPORTED THAT AFTER DA VINCI-ASSISTED NIPPLE AREOLAR SKIN SPARING MASTECTOMY, SENTINEL LYMPH NODE BIOPSY, AND LEFT BREAST RECONSTRUCTION WITH DEEP INFERIOR EPIGASTRIC PERFORATOR FLAP PROCEDURES, THE PATIENT PRESENTED WITH SYMPTOMS OF INFECTION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH NO COMPLICATIONS ON POSTOPERATIVE DAY 6. ON POSTOPERATIVE DAY 9, THE PATIENT PRESENTED WITH A FEVER OF 38 DEGREES CELSIUS OR HIGHER, SWELLING, HEAT, AND REDNESS IN THE LEFT BREAST, AND AN INCREASE IN THE AMOUNT OF DRAINAGE BY 3 TIMES WITH THE JACKSON-PRATT (JP) DRAIN. INTRAVENOUS (IV) ANTIBIOTICS WERE ADMINISTERED AFTER BLOOD, DRAINAGE FLUID, AND URINE CULTURES WERE PERFORMED IN THE EMERGENCY ROOM (ER) UNDER SUSPICION OF A POSTOPERATIVE INFECTION; MODERATE STAPHYLOCOCCUS AUREUS BACTERIA WERE FOUND IN THE DRAINAGE FLUID, AND NO BACTERIA WERE IDENTIFIED IN THE BLOOD OR URINE. THE INFECTION WAS CONFIRMED VIA A CHEST COMPUTED TOMOGRAPHY (CT), AND THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A WOUND INFECTION IN THE LEFT BREAST. IN ADDITION TO IV ANTIBIOTICS, THE PATIENT ALSO UNDERWENT A HEMATOMA EVACUATION SURGERY AT THIS TIME; THE HEMATOMA WAS LOCATED BELOW THE NIPPLE OF THE LEFT BREAST.

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

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEON WAS CHECKING THE FIRST TRAJECTORY OF A BILATERAL ANTERIOR NUCLEUS OF THE THALAMUS DEEP BRAIN STIMULATION CASE. THE TRAJECTORY DEVIATED FROM THE PLAN BY AT LEAST 2.5MM, SLIGHTLY MORE DEVIATED AT THE TARGET THAN THE ENTRY POINT. THE SURGEON CONTINUED ON TO THE SECOND TRAJECTORY. WHEN THE SECOND TRAJECTORY (RIGHT) POSITIONING WAS CHECKED WITH AN O-ARM SPIN, IT WAS NOTED THE FIRST TRAJECTORY (LEFT) WAS SHALLOWER AND EXTREMELY DEVIATED INTO THE VENTRICLE. THE SURGEON TRIED TO PLACE THE ELECTRODE BACK IN POSITION, DRIVING TO THE LEFT TRAJECTORY AGAIN. THE SURGEON ALSO TRIED TWO DIFFERENT TRAJECTORIES, ONE IN THE LATERAL HOLE OF THE STARDRIVE MICRODRIVE BEN-GUN AND ANOTHER NEW ROSA TRAJECTORY. THE FINAL TRAJECTORY WAS STILL DEVIATED FROM THE INTENDED TARGET BUT SURGEON CONTINUED ON AND CLOSED UP. THE SURGEON HAS SINCE DECIDED TO REPLACE THE LEFT ELECTRODE AT A LATER DATE. CASE END WAS DELAYED SEVERAL HOURS. SURGEON MENTIONED IT APPEARED THE CANNULA PUSHED THE BRAIN TO THE SIDE INSTEAD OF PIERCING THROUGH TISSUE AFTER GOING THROUGH THE LEFT VENTRICLE. THEN ONCE THE CANNULA WAS REMOVED THE ELECTRODE FLOATED INTO THE VENTRICLE. THE REVISION TO REPLACE THE LEFT ELECTRODE WAS PERFO

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL, INC. (ISI) REVIEWED A JOURNAL ARTICLE THAT DESCRIBES A PROSPECTIVE SINGLE-CENTER COHORT STUDY THAT WAS PERFORMED. THE AIM OF THE STUDY WAS TO REVIEW THE FIRST 100 PATIENTS IN THE IMPLEMENTATION PHASE OF A NEW DA VINCI ROBOTIC LIVER SURGERY PROGRAM IN THEIR INSTITUTION TO ASSESS THE USE OF THE IWATE DIFFICULTY SCORES IN PREDICTING SURGICAL DIFFICULTY AND POSTOPERATIVE COMPLICATIONS. THE CONCLUSION OF THE STUDY FOUND THAT THE IWATE CATEGORIES HAD THE ABILITY TO PREDICT BOTH THE DIFFICULTY OF SURGERY AS WELL AS POSTOPERATIVE OUTCOMES WHEN ASSESSING THE COMPLEXITY OF ROBOTIC LIVER SURGERY, WHICH MAY AID IN APPROPRIATE PATIENT SELECTION. THE STUDY OCCURRED FROM NOVEMBER 2020 TO JANUARY 2023. THE ARTICLE NOTED THAT MAJOR LIVER RESECTIONS WERE PERFORMED IN 17% OF CASES, WHILE ATYPICAL RESECTIONS WERE THE MOST COMMON AT 49%, WITH THE REMAINING BEING ANATOMICAL SEGMENTECTOMIES (17%) AND LEFT LATERAL SECTIONECTOMIES (13%). THE MEDIAN BLOOD LOSS WAS 300 ML, AND 22 (22%) PATIENTS RECEIVED PERIOPERATIVE BLOOD TRANSFUSIONS. CONVERSION TO OPEN SURGERY OCCURRED IN 6% OF CASES DUE TO INTRAOPERATIVE BLEEDING TENDENCY (3 CASES), VASCULAR INFILTRATION (2 CASES), AND ADHESIONS (1 CA

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.

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 WHILE USING THE NEW 5.1.1 SOFTWARE, THE NAVIGATION WAS SHOWING THE SCREW HIT THE BULLSEYE DEPTH, BUT THE SCREW WAS STILL PROUD. THE SURGEON CHECKED THE DEPTH WITH A PROBE AND BELIEVED IT WAS AT 40MM DEEP, INSTEAD OF 50 MM DEEP. THE SNAPSHOT WAS REDONE TO MAKE SURE ACCURACY WAS GOOD. THE SITE TOUCHED THE LAMINA WITH THE PASSIVE PLANAR PROBE AND THE SYSTEM SHOWED THAT IT WAS 5-10 MM PAST WHERE IT WAS LOCATED. AN ACCURACY CHECK ON THE DIVOT OF THE ARM GUIDE WAS MATCHING. THE REGISTRATION WAS REDONE AND THE SITE HAD TO AIRPLANE THE BED TO CONFIRM HOW DEEP THE SCREWS ACTUALLY WERE AND THEY WERE ABLE TO SEE THERE WAS PLENTY OF ROOM LEFT. WHEN AIRPLANING THE BED, THE SITE BELIEVED THE PATIENT ANATOMY SHIFTED SO THE ORIGINAL PILOT HOLE WAS INFERIOR AND MEDIAL. DURING THE LEFT L3 SEGMENT, THE SURGEON B REACHED THE INTERVERTEBRAL CANAL AND CENTRAL CANAL. NEUROMONITORING INDICATED SIGNAL LOSS ON THE LEFT SIDE. DESPITE THE CHALLENGES, THE PATIENT DID REGAIN THE ABILITY TO MOVE THEIR LEGS POST-OPERATION. DURING THE LEFT L3 PART, THE NAVIGATION SYSTEM INDICATED A 5 MM 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: THE STUDY ASSESSED THE IMPACT OF THE DA VINCI SURGICAL SYSTEM ON THYROID SURGERY BY ANALYZING 104 ROBOTIC THYROIDECTOMY CASES PERFORMED FROM MARCH 2018 TO JANUARY 2022. THE SURGERIES UTILIZED BOTH THE SI AND XI MODELS OF THE DA VINCI SURGICAL SYSTEM IN SEQUENCE. THE STUDY AIMED TO DETERMINE IF, AFTER AN INITIAL LEARNING CURVE, THE SYSTEM WOULD REDUCE OPERATIVE TIMES WHILE MAINTAINING LOW COMPLICATION RATES, THEREBY ENHANCING PATIENT CARE. RESULTS SHOWED A DECREASE IN TRANSIENT POSTOPERATIVE COMPLICATIONS, WITH THE INCIDENCE OF VOCAL CORD PALSY FALLING FROM 5.4% IN EARLY CASES TO 1.5% IN LATER CASES. THERE WERE NO REPORTED PERMANENT INJURIES TO THE RECURRENT LARYNGEAL NERVE OR CASES OF PERMANENT HYPOPARATHYROIDISM. EARLY-PHASE ISSUES INCLUDED RARE INSTANCES OF POSTOPERATIVE HEMORRHAGE AND TRACHEAL INJURY. NO ISI- PRODUCTS RELATED MALFUNCTIONS WERE MENTIONED IN THE ARTICLES. THE STUDY CONCLUDED THAT AS SURGEONS GAINED EXPERIENCE, ROBOTIC ASSISTANCE IMPROVED SURGICAL PRECISION AND LED TO CONSISTENT OUTCOMES. HOWEVER, IT NOTED LIMITATIONS SUCH AS THE SMALL SAMPLE SIZE, SHORT FOLLOW-UP DURATION, AND LACK OF COMPARISON WITH OTHER THYROIDECTOMY APPROACHES. ALTHOUGH SURGERY DURATION REDUCE

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NAGATA, K., GUM, J. L., BROWN, M., DANIELS, C., HINES, B., CARREON, L. Y., GLASSMAN, S. D. (2024). RISK FACTORS FOR MEDIAL BREACH DURING ROBOTIC-ASSISTED CORTICAL BONE TRAJECTORY SCREW INSERTION. WORLD NEUROSURGERY, 184. HTTPS://DOI.ORG/10.1016/J.WNEU.2024.01.168 OBJECTIVE: WE DESCRIBE THE INCIDENCE OF, AND IDENTIFY THE RISK FACTORS FOR, A MEDIAL BREACH OF THE PEDICLE WALL DURING ROBOTIC-ASSISTED CORTICAL BONE TRAJECTORY (RA-CBT) SCREW INSERTION. METHOD: WE ANALYZED A CONSECUTIVE SERIES OF ADULT PATIENTS WHO UNDERWENT RA-CBT SCREW PLACEMENT FROM JANUARY 2019 TO JULY 2022. TO ASSESS THE PEDICLE WALL MEDIAL BREACH, POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) IMAGES WERE ANALYZED. PATIENT DEMOGRAPHIC DATA AND SCREW DATA WERE COMPARED BETWEEN PATIENTS WITH AND WITHOUT A MEDIAL BREACH. THE HOUNSFIELD UNITS (HUS) ON THE L1 MIDVERTEBRAL AXIAL CT SCAN WAS USED TO EVALUATE BONE QUALITY. RESULT: OF 784 CBT SCREWS IN 145 PATIENTS, 30 (3.8%) HAD A MEDIAL BREACH IN 23 PATIENTS (15.9%). ONE SCREW WAS GRADE 2, AND THE OTHERS WERE GRADE 1. PATIENTS WITH A MEDIAL BREACH HAD A LOWER HU VALUE COMPARED WITH THE PATIENTS WITHOUT A MEDIAL BREACH (123.3 VS. 150.5; P [0.027). A MEDIAL BREACH WAS MORE COMMON IN

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.