ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND DURING 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.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A MONARCH BRONCHOSCOPY PROCEDURE, THERE WAS A SIGNIFICANT CHANGE IN THE PATIENT'S VITAL SIGNS, PROMPTING INTERVENTION BY THE ANESTHESIOLOGIST. THE PATIENT, WHO WAS ELDERLY, EXPERIENCED A CARDIAC EVENT, AND THE PROCEDURE WAS SUBSEQUENTLY ABORTED. THE ATTENDING PHYSICIAN CONFIRMED THAT THE PATIENT HAD SUFFERED A HEART ATTACK. THE PATIENT WAS TRANSFERRED TO THE CATH LAB AND, UNFORTUNATELY, PASSED AWAY LATER THAT DAY. IT IS NOTED THAT THE CLINICAL STAFF DOES NOT ATTRIBUTE THE PATIENT EVENT TO THE MONARCH ROBOT.

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 NOT PLACED DEEP ENOUGH AND HAD TO BE REVISED INTRAOPERATIVELY. THIS EVENT OCCURRED IN ITALY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND DURING 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 A SCREW WAS MISPLACED USING THE EXCELSIUS GPS SYSTEM.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT APPROXIMATELY 25-30 MINUTES INTO A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY PROCEDURE, THE PATIENT EXPERIENCED HEMODYNAMIC INSTABILITY WITH A DROP IN BLOOD PRESSURE AND HYPOXIA. THE CARDIAC ANESTHESIOLOGIST PERFORMED A TRANSESOPHAGEAL ECHOCARDIOGRAM AND A CO2 GAS EMBOLUS WAS OBSERVED IN THE RIGHT VENTRICLE. THE SURGICAL FELLOW REPORTED THAT THE PATIENT WAS IN A TRENDELENBURG POSITION OF APPROXIMATELY 10 DEGREES AND THE 3RD PARTY INSUFFLATION DEVICE PRESSURE WAS SET TO 12 MMHG. THE PROCEDURE WAS ABORTED; THEY WERE AT THE PROSTATE ENUCLEATION STEP WITH APPROXIMATELY ANOTHER 15-20 MINUTES REMAINING IN THE PROCEDURE. THE PATIENT DECOMPENSATED A SECOND TIME IN THE INTENSIVE CARE UNIT AND EXPIRED ABOUT 4-5 HOURS POST-OPERATIVELY. THE PATIENT HAD A HISTORY OF CARDIAC COMORBIDITIES. THE REPORTED CAUSE OF DEATH WAS CO2 EMBOLUS AND MYOCARDIAL INFARCTION. THE FELLOW STATED THAT THE EVENT WAS NOT CAUSED BY ANY DA VINCI PRODUCT; IT WAS A COMBINATION OF THE PRE-EXISTING CARDIAC CONDITION AND ABSORPTION OF CO2 GAS.

ROSA Robotic Surgery — 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 ROSA SHOULDER PROCEDURE, REAMING RESULTED IN AN OBLONG HOLE DUE TO HARD BONE. THE SURGEON GRAFTED THE OBLONG DEFECT CREATED BY THE REAMING. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY X-RAY DURING 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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND REMAINING SCREWS WERE THEN PLACED BY HAND.

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

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED DURING THE MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A BLEED. THE PHYSICIAN REPORTED THE BLEEDING WAS NOT DUE TO MONARCH BUT RATHER JUST A RISK OF BIOPSYING THIS SPECIFIC PATIENT. THE PATIENT WAS ADMITTED FOR OBSERVATION ONLY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THERE WAS A RED TAG ERROR DURING CASE SET UP. "PIB HARDWARE COMMUNICATION STOPPED."

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND. THIS EVENT OCCURRED IN (B)(6).

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 THE MONARCH BRONCHOSCOPY PROCEDURE THE ARMS WERE STUCK IN STOW POSITION AND WILL NOT RESPOND. THE PHYSICIAN POWER CYCLED THE MONARCH SYSTEM A COUPLE OF TIMES AND RECONNECTED THE SYSTEM; HOWEVER, THERE WAS NO CHANGE. THE PHYSICIAN ELECTED TO ABORT THE CASE AND RESCHEDULE FOR A LATER DATE. THERE WAS NO REPORT OF AN ADVERSE EVENT DUE TO 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.

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 THE PROCEDURE PATIENT EXPERIENCE ABDOMINAL DISTENTION AND RESPIRATORY DISTRESS AND WAS HOSPITALIZE AND DRAIN PLACEMENT WAS PERFORM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND DURING SURGERY. THIS EVENT OCCURRED IN IRELAND.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE EGPS SYSTEM IS NOT WORKING PROPERLY SINCE IT WAS SERVICED ON WEDNESDAY OF THIS WEEK. WE NEED THIS FIXED ASAP. THE ROBOT SEEMED "SLOW". THE SURGEON WOULD STOP ADVANCING THE SCREW BUT THERE WAS A HALF SECOND DELAY ON THE SCREEN. I AM NOT SURE IF IT IS E3D OR EGPS. WE HAD TO ABORT AND USE FLUORO.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY FLURO DURING 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 BY HAND DURING SURGERY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

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

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THE ROSA HUMERAL CLAMP CREATED A HOLE THROUGH THE CORTICAL BONE, AND CAUSED A FRACTURE WHILE IMPLANTING THE STEM. FRACTURE OF THE HUMERUS NEEDED CERCLAGE WIRE AROUND FINAL IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER NONE IS AVAILABLE AT THIS TIME.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THERE WAS PATIENT COMPLICATIONS. THE PATIENT HAD SEVERE HYPOXEMIA. THE PHYSICIAN HIT A VESSEL. AFTER REMOVING THE SCOPE THE PATIENT STARTED TO HEMORRHAGE. THE PHYSICIAN STABILIZED THE HEMORRHAGE WITH A MANUAL SCOPE AND COMPLETED THE PROCEDURE SUCCESSFULLY. THE CHEST TUBE WAS PLACED AND PATIENT WAS HOSPITALIZED AND RELEASED.

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 DURING 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 BY HAND DURING 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 POST OP SCANS SHOWS A SCREW ON THE SAGGITAL AND HAD PERFORATED ANTEROLATERALLY ON THE AXIAL. THIS EVENT OCCURRED IN THE UNITED KINGDOM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CAMERA WAS PLUGGED IN UPON CASE SET UP AND RED "CAMERA BUMP" WARNING APPEARED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND DURING SURGERY.

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.

ROSA Robotic Surgery — 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 TIP OF THE REAMER WAS 6MM TOO POSTERIOR COMPARED TO PLAN. THE SURGEON HAD TO GRAFT THE HOLE AND REAMED AGAIN WITH CONVENTIONAL INSTRUMENTATION TO PREPARE THE CENTRAL HOLE. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

ROSA Robotic Surgery — 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 UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY WHICH HAD TO BE CANCELLED DURING THE PROCEDURE AS THE DISTAL RESECTION RESULTED IN SEVERE VALGUS.ALL LANDMARKS WERE TAKEN CORRECTLY AND NO DRIFTING OCCURRED DURING THE RESECTION. THE BONE HAD TO BE REBUILT WITH WEDGES. THERE WAS A 30 (THIRTY) MINUTE DELAY TO REBUILD THE BONE. THERE IS NO ADDITIONAL 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: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE, THE PATIENT DIED OF A PULMONARY EMBOLISM ON AN UNSPECIFIED DATE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS AND THE PATIENT HAD A FAST INITIAL POST-OPERATIVE RECOVERY. THE SURGEON AND THE HOSPITAL TEAM DO NOT THINK THIS IS DIRECTLY RELATED TO THE DA VINCI SINGLE PORT (SP) SYSTEM USED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE SURGEON AND A RESPONSE IS PENDING.

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

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CAMERA WAS PLUGGED IN AND THE 'CAMERA BUMP' WARNING APPEARED. THE CASE WAS CANCELLED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PREPARING FOR A CRANIAL CASE, TURN ROBOT ON, AND NOT GETTING PAST THE EXCELSIUS GPS HOME SCREEN. TRIED RESTARTING AND POWER CYCLING, UNPLUGGING FOR MULTIPLE MINUTES. HAVE NOT BEEN ABLE TO GET PAST IT.

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 ALL THE USERS PASSWORDS HAD EXPIRED AND THEY WERE UNABLE TO LOGIN TO THE MONARCH SYSTEM. THE PHYSICIAN ELECTED TO ABORT THE CASE AND RESCHEDULED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND.

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 THAT DESCRIBED A COHORT STUDY OF 2225 PATIENTS THAT UNDERWENT ROBOT-ASSISTED SURGERY (RAS) IN GYNECOLOGICAL ONCOLOGY FROM JANUARY 2015 TO DECEMBER 2022. THE AIM OF THE STUDY WAS TO PROVIDE A COMPREHENSIVE DESCRIPTION OF PERIOPERATIVE MORBIDITY ASSOCIATED WITH ROBOT-ASSISTED SURGERY (RAS) IN GYNECOLOGICAL ONCOLOGY TO ENHANCE PREOPERATIVE COUNSELING AND SUPPORT SHARED DECISION-MAKING. A GYNECOLOGICAL ONCOLOGIST PERFORMED THE SURGERY IN 98% OF THE CASES, AND 64% OF THESE SURGEONS WERE ALREADY EXPERIENCED IN RAS (>50 ROBOTIC PROCEDURES). THE DA VINCI SI SYSTEM WAS USED IN 524 CASES AND THE DA VINCI XI SYSTEM IN 1701 CASES. AMONG THE 2225 PATIENTS, THE ARTICLE NOTED THAT ONE PATIENT DIED DUE TO CARDIOGENIC SHOCK 2 WEEKS AFTER UNCOMPLICATED RAS, THE CAUSE OF DEATH WAS FOUND TO BE MAJOR THROMBOEMBOLIC EVENT (TEE). THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHORS ALLEGE THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENTS. THE STUDY CONCLUDED THAT RAS IN A HIGH-VOLUME GYNECOLOGICAL ONCOLOGY SETTING RESULTED IN LOW RATES OF MAJOR PERIOPERATIVE MORBIDITY AND CONVERSION TO LAPAROTOMY. THE FINDINGS SUPPORT THE USE OF RAS FOR SUITABLE PATIEN

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A DBS CASE SET UP A CAMERA HARDWARE MALFUNCTION, WARNING DISPLAYED ONCE THE CAMERA WAS PLUGGED IN. THE JAR ALARM INDICATOR LIGHT WAS ALSO ILLUMINATED.

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 POST OP CT SCAN CONFIRMED.

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 POST OP CT SCAN SHOWS MULTIPLE MEDIAL BREACHES.

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.

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, WITH SUBSEQUENT DURAL TEAR THAT WAS REPAIRED.

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.