LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE EXPIRATION DATE IS NOT KNOWN. THE DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED OR DEVICE EVALUATION COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE MANUFACTURE DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT.
D
Patient 1
IT WAS REPORTED THAT AT THE BEGINNING OF THE PROCEDURE, AFTER INITIAL HYSTEROSCOPY, THE DEFICIT WAS 600ML. THE PHYSICIAN ZEROED OUT THE FLUID MANAGEMENT SYSTEM. IT WAS NOTED THAT THE VISUALIZATION WAS POOR. THE PHYSICIAN TOOK "ONE CUT" OF THE PATHOLOGY AND THE FIBROID STARTED BLEEDING. HOLOGIC REPRESENTATIVE NOTED THAT THE WASTE BAGS WERE NOT HUNG PROPERLY WHICH COULD HAVE ATTRIBUTED TO THE INITIAL HIGH DEFICIT READING. THEY HAD A HARD TIME CONTROLLING THE BLEEDING SO THE PATIENT WAS SENT TO INTERVENTIONAL RADIOLOGY FOR UTERINE EMBOLIZATION. PATIENT STAYED OVER NIGHT FOR OBSERVATION. SHE WAS DISCHARGED AND DOING WELL. NO ADDITIONAL DETAILS AVAILABLE.