BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURESTRAP

    MDR report key: 2770257 · Received September 17, 2012

    Report

    Report Number
    2770257
    Event Type
    Malfunction
    Date Received
    September 17, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 17, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    MD HAD USED THE SECURESTRAP LAPAROSCOPICALLY APPROXIMATELY NINE TIMES.HOWEVER, AFTER THAT IT LOCKED UP AS IF IT WAS OUT OF STAPLES. A NEW ONE WAS OPENED AND WORKED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURESTRAP FIXATION DEVICE GDW ETHICON ENDO-SURGERY, INC. SECURESTRAP 6626MU

    Patients

    Seq Age Sex Outcome Treatment
    1 *