BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURESTRAP

    MDR report key: 2933612 · Received January 25, 2013

    Report

    Report Number
    2933612
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER APPROXIMATELY 5 SHOTS, THE ETHICON SECURESTRAP INSTRUMENT JAMMED AND WOULD NOT FIRE ANOTHER TACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36464 SECURESTRAP STAPLE, IMPLANTABLE GDW ETHICON, INC * H206STRAP252M

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR