BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM ENDOSCOPIC KIT 5MM THREADED GRIPPER

    MDR report key: 35412 · Received July 5, 1996

    Report

    Report Number
    35412
    Event Type
    Malfunction
    Date Received
    July 5, 1996
    Date of Event
    April 3, 1996
    Report Date
    April 4, 1996
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GEN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE DOING AN ENDOSCOPIC HERNIOPLASTY THE THREADED GRIPPER BROKE WHILE BEING USED ON THE PT. DATE REMOVED: 4/10/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ENDOSCOPIC KIT 5MM THREADED GRIPPER THREADED GRIPPER GEN ORIGIN MEDSYSTEMS, INC. * 030596

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR