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.

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 SCREW DEVIATION IN A SCAN AND PLAN CASE. THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE PATIENT WAS HAVING MULTIPLE SCREWS PLACED FROM THE THORACIC TO THE LUMBAR VERTEBRAE FOR A SCOLIOSIS PROCEDURE. THE REP REPORTED THAT MULTIPLE ACCURACY CHECKS WERE PERFORMED, HOWEVER, WHEN T4 ON THE RIGHT SIDE WAS DRILLED, THE PATIENT'S MOTOR WAS TESTED AND WAS ABSENT. WHEN A POST SURGICAL SCAN WAS PERFORMED, THE SCREW PLACED IN T5 WAS POTENTIALLY DEVIATED BY 1-2 MILLIMETERS (MM), BUT PER THE REP, THE SURGEON BELIEVED THAT THE T4 DRILL WAS ACCURATE AND THAT THE PEDICLE FRACTURED ON THE RIGHT SIDE. ALL OTHER SCREWS PLACED IN THE LEFT AND RIGHT VERTEBRAE APPEARED ACCURATE IN THE SOFTWARE. THERE WAS NO SURGICAL DELAY TIME AND THE PATIENT WAS AFFECTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOTIC MEGA SUTURE CUT NEEDLE DRIVER'S WIRES BROKE WHILE INSIDE PATIENT. SURGEON AWARE. NO VISIBLE SIGNS OF ANY PIECES LEFT INSIDE PATIENT. INSTRUMENT REMOVED FROM SERVICE AND GIVEN TO RISK MANAGER.

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.

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 LITERATURE ARTICLE DESCRIBING A RETROSPECTIVE ANALYSIS OF ALL PATIENTS UNDERGOING DA VINCI-ASSISTED ROBOTIC DISTAL PANCREATECTOMY (DP) AND PANCREATICODUODENECTOMY (PD) PROCEDURES PERFORMED BY A SINGLE SURGEON, WAS COMPLETED. THE STUDY EVALUATED THE SAFETY AND FEASIBILITY OF INSTITUTING A ROBOTIC PANCREATECTOMY PROGRAM. THE STUDY INCLUDED SURGERIES FROM MAY 2014 TO DECEMBER 2020, DURING WHICH 62 PATIENTS UNDERWENT ROBOTIC PANCREATECTOMY, 34 PATIENTS WERE IN THE PD GROUP AND 28 PATIENTS WERE IN DP GROUP. 13 PATIENTS REQUIRED CONVERSION TO OPEN SURGERY IN PD GROUP DUE TO VEIN RESECTION, BILIOPANCREATIC RESECTION OR DIFFICULT DISSECTION. POST-OPERATIVELY, IN THE PANCREATICODUODENECTOMY (PD) GROUP, NINE PATIENTS (26.5%) EXPERIENCED CLAVIEN-DINDO GRADE III OR MORE COMPLICATIONS COMPARED TO 5 PATIENTS (17.9%) IN THE DISTAL PANCREATECTOMY (DP) GROUP. OF THE 5 GRADE B/C POSTOPERATIVE PANCREATIC FISTULA (POPF) IN THE PD GROUP, 4 PATIENTS REQUIRED OPERATIVE INTERVENTION WHILST ALL OF THOSE IN THE DP GROUP WERE MANAGED EITHER ENDOSCOPICALLY OR WITH PROLONGED USE OF SURGICAL DRAINS. THREE PATIENTS EXPERIENCED POST-PANCREATECTOMY HEMORRHAGE IN PD GROUP WHILE 1 PATIENT IN DP GROUP.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEON USED THE NS INSTRUMENTATION TO MARK PLACEMENT OF THE BURR HOLES. THE PATIENT AND EGPS WERE DRAPED AND THE IGEE WAS VERIFIED BY THE SCRUB TECH. THE EGPS WAS PUSHED IN WITH THE O-ARM STILL IN SCAN POSITION TO ALLOW FOR EVALUATION SHOTS. ONCE THE INCISION/APPROACH WAS COMPLETED, THE ARM WAS BROUGHT IN ALONG THE VIM R TRAJECTORY. AS THE SURGEON PLACED THE CANNULA IN THE CENTRAL TRAJECTORY, THE ENTRY POINT APPEARED TO BE CLOSE TO THE POSTERIOR EDGE OF THE BURR HOLE COVER. AS THE SURGEON INSERTED THE CANNULA, HE BOVIED THE CANNULA WHICH CAUSED THE EGPS SCREEN TO TEMPORARILY BLACK OUT DURING THE BOVIE USAGE WHEN THE CANNULA WAS SEATED, AN O-ARM SPIN WAS PERFORMED TO CHECK CANNULA PLACEMENT. THE CANNULA TRAJECTORY WAS OFF WITH THE ENTRY POINT POSTERIOR AND THE TRAJECTORY POINTING ANTERIOR. THE TIP OF THE CANNULA (PLANNED FOR 10MM ABOVE TARGET) PRESENTED A DEVIATION OF E/ 11.5 AND E/1.4. LANDMARK CHECKS WERE PERFORMED AGAIN AND IT APPEARED THAT THE CENTER OF THE BURR HOLE SHOWED ANTERIOR OF THE PLANNED TRAJECTORY ON THE SCREEN. A STERILE REGISTRATION WAS THEN PERFORMED BUT FOLLOWING THE TRANSFER OF THE SPIN AND CONFIRMATION OF THE FIDUCIALS, THE EGPS PRESENTED AN ERROR STATING T

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 THE MEDICAL CRUCIATE LIGAMENT WAS UNINTENTIONALLY CUT. IT WAS REPORTED THAT REVISION COMPONENTRY WAS REQUIRED. THE LIGAMENT WAS REPAIRED AND IMPLANTED COMPONENTS LOOKED GOOD. IT WAS REPORTED BY THE SURGEON THAT THE RETRACTORS SHOULD HAVE BEEN PLACED BETTER. IT WAS REPORTED THAT THE DEVICE WAS BEING USED WITH A ROBOTIC ASSISTED BASE STATION DEVICE. THERE WERE NO DELAYS IN THE PROCEDURE REPORTED. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

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 STUDY TO EVALUATE THE ONCOLOGICAL OUTCOMES POST TRANSORAL ROBOTIC SURGERY (TORS) FOR HUMAN PAPILLOMAVIRUS (HPV)-ASSOCIATED OROPHARYNGEAL SQUAMOUS CELL CARCINOMA, WAS SUMMARIZED IN A LITERATURE ARTICLE DESCRIBING A RETROSPECTIVE ANALYSIS ON 184 PATIENTS THAT UNDERWENT DA VINCI-ASSISTED TRANSORAL ROBOTIC SURGERY (TORS) WITH NECK DISSECTION IN ONE SINGLE INSTITUTION PERFORMED BY TWO TRAINED SURGEONS. POST-OPERATIVE TORS-RELATED COMPLICATIONS OCCURRED IN 12 PATIENTS (6.5%). NINE PATIENTS (4.9%) HAD A SECONDARY POST-OPERATIVE BLEED, DEFINED AS BLEEDING OCCURRING GREATER THAN 24 HOURS FOLLOWING SURGERY, WITH ALL PATIENTS BEING SUCCESSFULLY MANAGED EITHER CONSERVATIVELY OR WITH OPERATIVE MANAGEMENT. SALIVARY FISTULA OCCURRED IN 2 PATIENTS (1.1%). PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) INSERTION FOR SWALLOWING DYSFUNCTION OCCURRED IN 10 PATIENTS (5.4%) WITH ONLY 2 PATIENTS (1.1%) REQUIRING FOR GREATER THAN 12 MONTHS. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. ATTEMPTS WERE MADE TO CONTACT THE ARTICLE AUTHOR, BUT NO RESPONSE HAS BEEN RECEIVED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE ANALYSIS BETWEEN 2011-2022 OF 184 PATIENTS THAT UNDERWENT DA VINCI ASSISTED TORS SURGERY WITH NECK DISSECTION IN ONE SINGLE INSTITUTION, PERFORMED BY TWO TRAINED SURGEONS. THE STUDY WAS CONDUCTED TO EVALUATE THE ONCOLOGICAL OUTCOMES OF POST-TRANSORAL ROBOTIC SURGERY (TORS) FOR HPV-ASSOCIATED OROPHARYNGEAL SQUAMOUS CELL CARCINOMA. THE 3-YEAR AND 5-YEAR DISEASE-SPECIFIC SURVIVAL WERE 98.6% (95% CI 96.7¿100%) AND 94.4% (95% CI 89.9¿99.0%), RESPECTIVELY. THREE PATIENTS DIED FROM CAUSES UNRELATED TO DISEASE RECURRENCE. ONE PATIENT (0.5%) HAD AN EARLY POSTOPERATIVE HEMORRHAGE, DEFINED BY BLEEDING OCCURRING LESS THAN 24 HOURS FOLLOWING SURGERY, RESULTING IN DEATH FOUR DAYS LATER. ONE PATIENT DIED FROM CARDIOPULMONARY ARREST; ANOTHER PATIENT DIED FROM A SECOND TUMOR METASTASIS. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE HAS BEEN RECEIVED.

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: 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.

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.

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.

At 10:00 p.m. on February 22, 2024, an employee working as a machine operator for a landscape architectural service had been monitoring a production line (Line 1). The employee started his shift at 3:00 p.m. He was operating the conveyer that carries pallets loaded with landscape materials such as bags of mulch, decorative rocks, and soil. The employee works with a robotic arm that picks up landscape materials from the conveyor and places them on a pallet. When the pallet is full, it moves down the conveyer. A coworker who operates a forklift noticed a pallet was crooked and mentioned it to the employee before leaving the area to do his assigned work. After returning to the area, the coworker saw the employee inside the cage with the door closed. The employer stated that the employee must have entered across the conveyer causing the robot to pick the employee up thinking he was a pallet. The employee was caught within the cage under a robotic arm and died from crushing injuries to his chest.

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.