Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 AFTER BLEEDING WAS NOTICED. SHORTLY AFTER, THE PATIENT DISPLAYED SUSPECTED PRESENCE OF STROKE AND/OR HEMATOMA.

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.

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 ROBOTIC BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. A VALVE WAS PLACED AND PATIENT WAS HOSPITALIZED. NO DEVICE ISSUES WERE REPORTED.

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 ROBOTIC BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. A CHEST TUBE WAS PLACED. NO SYSTEM ISSUES WERE REPORTED.

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 ROBOTIC BRONCHOSCOPY PROCEDURE THE PHYSICIAN HAD DIFFICULTY WITH THE PATIENT SENSORS AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 PRESENTED 3 WEEKS OR 3 MONTHS POST-OP WITH A FRACTURED FEMUR AT THE LOCATION WHERE THE FEMORAL REFERENCE PINS WERE INSTALLED. ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED TO CORRECT THE FRACTURE. 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 DURING THE MONARCH BRONCHOSCOPY PROCEDURE, THE PHYSICIAN WAS PERFORMING THE BRONCHOALVEOLAR LAVAGE (BAL) WHEN THE PATIENT HAD A CARDIAC ARREST. THE PHYSICIAN WAS ABLE TO CONFIRM A PULSE BACK ON THE PATIENT. THE PATIENT IS IN STABLE CONDITION.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THROUGH A MEDWATCH RECEIVED FROM THE FDA ALLEDGING OCCURANCES OF INACCURATE CUTS AND INCORRECT PLACEMENT OF IMPLANTS RESULTING IN PATIENT INJURIES. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

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 PHYSICIAN USED EBUS TO TARGET THE RIGHT UPPER LOBE (RUL). THE PHYSICIAN NOTICED THROUGH HIS MANUAL SCOPE THAT THERE WAS A SMALL LACERATION ON THE MUCOSA OF THE POST INTERIOR WALL OF THE RIGHT MAIN STEM. THE PHYSICIAN WAS NOT SURE HOW THIS OCCURRED. THE PHYSICIAN DECIDED TO ABORT THE CASE BECAUSE THEY DID NOT WANT TO CAUSE ANY FURTHER INJURY. THE PATIENT DID NOT EXPERIENCE ANY BLEEDING UPON WAKING UP. NOTABLY, THE ANESTHESIOLOGIST SUGGESTED THAT THE PATIENT MAY HAVE HAD FRAIL TISSUE, AND THE PHYSICIAN RECALLED A SIMILAR INCIDENT FROM TWO YEARS PRIOR IN THE SAME LOCATION, WHICH HAD RESOLVED WITHOUT COMPLICATIONS.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED DIFFICULTY NAVIGATING AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 AND ADJUSTED INTRA-OPERATIVELY.

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 THE BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED MEDIASTINAL EMPHYSEMA, AS INDICATED BY THE POSTOPERATIVE CT EXAMINATION. AFTER A FOLLOW-UP CT SCAN DEMONSTRATED RECOVERY, THE PATIENT WAS DISCHARGED ON (B)(6), FOLLOWING A TOTAL HOSPITAL STAY OF 6 DAYS.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 ROBOTIC BRONCHOSCOPY PROCEDURE, THE PATIENT HAD A PNEUMOTHORAX. A CHEST TUBE WAS PLACED AND THE PATIENT WAS MONITORED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT WAS DISCHARGED HOME SIX DAYS AFTER THE PROCEDURE.

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 THERE WAS OVER RESECTION ON BOTH THE DISTAL FEMORAL AND PROXIMAL TIBIAL RESECTIONS, WITH A NET OVER RESECTION OF 4MM. THE CALIPER OF BONE MATCHED VALIDATED CUTS. PLANNED POLY WAS 10MM, RESULTING IN 13MM POLY WITH ADDITIONAL SOFT TISSUE RELEASES. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

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 (VIA MEDSUN UF/IMPORTER REPORT # (B)(4)) THAT AFTER THE MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX.

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 PROCEDURE THE PHYSICIAN WAS UNABLE TO TURN THE BRONCHOSCOPE ON AFTER REMOVING THE SCOPE FROM THE PATIENT'S TRACHEA DUE TO THE CAMERA IMAGE BEING GRAINY AND ULTIMATELY GOING BLACK. THE PHYSICIAN ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: I LIVE WITH THE CHIEF TECHNOLOGY OFFICER FOR (B)(4), A DISTRIBUTORSHIP IN THE SOUTHEAST, FOR ZB CORPORATE. I HAVE OVERHEARD BUSINESS CALLS OF HOW THERE IS A PROBLEM WITH THE SOFTWARE ON THE ROBOTS AND THEY HAVE BEEN MAKING INCORRECT CUTS AND INCORRECT PLACEMENT OF IMPLANTS INTO PATIENTS FOR MONTHS. IT¿S A SYSTEM WIDE PROBLEM NOT JUST A FEW ROBOTS, MANY ROBOTS THEY HAVE OVER THE US ARE MALFUNCTIONING AND THEY HAVE YET TO FIGURE OUT THE EXACT CAUSE. IT¿S GONE AS HIGH UP THE CHAIN AS THE CEO BUT NOTHING IS BEING DONE. THEY HAVEN¿T SHUT DOWN USE. THEY JUST KEEP DOING INCORRECT AND IMMORAL SURGERIES ON PATIENTS AND NOT INFORMING THE DOCTORS THAT THEIR ROBOTS ARE THE REASON FOR THE POOR SURGERIES AND RESULTS. THEY HAVE BEEN TRYING TO FIX THE ISSUE AND COVER IT UP SINCE ZB FIRST BECAME AWARE. AS OF RIGHT NOW IT¿S NOT FIXED AND THEY ARE LETTING SURGEONS CONTINUE TO MAKE HARMFUL, PAINFUL IMPLANTS INTO PATIENTS. THEY¿VE FIRED ANYONE THAT CAME CLOSE TO DISCOVERING THE ISSUE. I LIVE WITH THE CHIEF TECHNOLOGY OFFICER FOR (B)(4), THE DISTRIBUTORSHIP FOR ZIMMER BIOMET IN THE SOUTHEAST DIVISION. THE ROSA ROBOT SOFTWARE HAS BEEN MALFUNCTIONING AND MAKING MISCUTS CONSTANTLY AND CAUSING HARM TO PATIE

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: THE FRACTURE WAS CAUSED BY FAILURE TO CLEAR THE POSTERIOR ASPECT OF THE PS BOX. NETHER THE VELYS CUTS OR THE SAGITTAL SAW CUTS WERE THE BLAME.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: I LIVE WITH THE CHIEF TECHNOLOGY OFFICER FOR (B)(6), A DISTRIBUTORSHIP IN THE SOUTH EAST, FOR ZB CORPORATE. I HAVE OVERHEARD BUSINESS CALLS OF HOW THERE IS A PROBLEM WITH THE SOFTWARE ON THE ROBOTS AND THEY HAVE BEEN MAKING INCORRECT CUTS AND INCORRECT PLACEMENT OF IMPLANTS INTO PATIENTS FOR MONTHS. IT¿S A SYSTEM WIDE PROBLEM NOT JUST A FEW ROBOTS, MANY ROBOTS THEY HAVE OVER THE US ARE MALFUNCTIONING AND THEY HAVE YET TO FIGURE OUT THE EXACT CAUSE. IT¿S GONE AS HIGH UP THE CHAIN AS THE CEO BUT NOTHING IS BEING DONE. THEY HAVEN¿T SHUT DOWN USE. THEY JUST KEEP DOING INCORRECT AND IMMORAL SURGERIES ON PATIENTS AND NOT INFORMING THE DOCTORS THAT THEIR ROBOTS ARE THE REASON FOR THE POOR SURGERIES AND RESULTS. THEY HAVE BEEN TRYING TO FIX THE ISSUE AND COVER IT UP SINCE ZB FIRST BECAME AWARE. AS OF RIGHT NOW IT¿S NOT FIXED AND THEY ARE LETTING SURGEONS CONTINUE TO MAKE HARMFUL, PAINFUL IMPLANTS INTO PATIENTS. THEY¿VE FIRED ANYONE THAT CAME CLOSE TO DISCOVERING THE ISSUE. I LIVE WITH THE CHIEF TECHNOLOGY OFFICER FOR (B)(6), THE DISTRIBUTORSHIP FOR ZIMMER BIOMET IN THE SOUTHEAST DIVISION. THE ROSA ROBOT SOFTWARE HAS BEEN MALFUNCTIONING AND MAKING MISCUTS CONSTANTLY AND CAUSING HARM TO PATI

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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.

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

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN WAS UNABLE TO QUERY PACS (PICTURE ARCHIVING AND COMMUNICATION SYSTEM) AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.