BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYA-5 5FR GRASPER FORCEP

    MDR report key: 1799919 · Received August 12, 2010

    Report

    Report Number
    2183680-2010-00039
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    July 15, 2010
    Report Date
    August 12, 2010
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    HIN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    GYRUS ACMI WAS UNABLE TO VERIFY THE COMPLAINT AT OUR FACILITY. THE DEVICE WAS SENT BACK TO THE VENDOR, ACCELLENT FOR EVALUATION. THE FINDINGS ARE AS FOLLOWS: VISUALLY THE STATIONARY JAW HAS BROKEN OFF OF THE DEVICE. THE DEVICE SHAFT WAS VISUALLY INSPECTED AND THE SHAFT IS BENT TO THE LEFT SIDE AND IS NO LONGER STRAIGHT. THIS IS COMMON WITH DEVICES THAT HAVE HAD LATERAL AND OR EXCESSIVE FORCE APPLIED TO THEM. THERE ARE NO OTHER DEFECTS DETECTED. THESE DEVICES ARE VISUALLY AND FUNCTIONALLY TESTED 100% PRIOR TO PACKAGING. THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO DISCREPANCIES FOUND.

    Description of Event or Problem · 1

    DURING A HYSTEROSCOPY BIOPSY WHILE USING OUR GRASPER FORCEPS, THE JAW PIECE BROKE AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT USING ACMI BIOPSY FORCEPS WITH NO PATIENT HARM. THE PROCEDURE WAS COMPLETED WITH NO FURTHER INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYA-5 5FR GRASPER FORCEP GRASPER FORCEP HIN GYRUS MEDICAL INC. GYA-5 1622

    Patients

    Seq Age Sex Outcome Treatment
    1