BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDO5 DISPOSABLE AUTOMATIC APPLIER

    MDR report key: 734028 · Received June 30, 2006

    Report

    Report Number
    3003898360-2006-00006
    Event Type
    Other
    Date Received
    June 30, 2006
    Report Date
    June 30, 2006
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT REPORTED BY THE USER FACILITY THAT THE APPLIER USED IN THIS CASE WAS INADVERTENTLY THROWN AWAY. THE LOT NUMBER OF THE APPLIER WAS NOT DOCUMENTED PRIOR TO BEING DISCARDED. TELEFLEX MEDICAL IS CURRENTLY EVALUATING PAST HISTORY OF PURCHASES TO DETERMINE WHICH LOT NUMBER WAS POSSIBLY USED. IF LOT NUMBERS ARE OBTAINED, TELEFLEX MEDICAL WILL PROVIDE A DEVICE HISTORY RECORD EVALUATION.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYCECTOMY PROCEDURE, ONE OF THE APPLIER JAW FELL OFF INTO THE SURGICAL FIELD. MINIMAL ADDITIONAL TIME REQUIRED TO RETRIEVE JAW. NO INJURY TO PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO5 DISPOSABLE AUTOMATIC APPLIER LIGATION CLIP APPLIER GDO TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention