BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGID 3-PRONG GRASPER FOR RETRIEVAL OF STONES

    MDR report key: 1785684 · Received July 29, 2010

    Report

    Report Number
    1519132-2010-00019
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    June 14, 2010
    Report Date
    July 29, 2010
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    JEK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED TO GYRUS ACMI. IT IS BEING SENT TO A THIRD PARTY REPAIR FACILITY, SMS, FOR EVAL. AS A RESULT, A DETERMINATION CAN NOT BE MADE AT THIS TIME. IF FURTHER INFO BECOMES AVAILABLE FROM THE REPAIR FACILITY, GYRUS ACMI WILL UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A PROCEDURE TO REMOVE A KIDNEY STONE FRAGMENT THROUGH THE SCOPE, THE ENTIRE END OF THE 3 PRONG GRASPING FORCEPS BROKE OFF IN THE KIDNEY. THE PIECE WAS RETRIEVED FROM THE PT USING ANOTHER GRASPER WITH NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGID 3-PRONG GRASPER FOR RETRIEVAL OF STONES RIGID 3-PRONG GRASPING FORCEPS JEK GYRUS ACMI, INC. RPG-437

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR