BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 6931449 · Received October 9, 2017

    Report

    Report Number
    1219930-2017-07865
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    September 4, 2017
    Report Date
    September 12, 2017
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884521191013
    PMA / PMN Number
    K133938
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, THE DEVICE WAS UNABLE TO FIRE. THE GREEN BUTTON WAS UNABLE TO BE PRESSED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710087 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIATRS60AMT N6M0100KRX 10884521191013

    Patients

    Seq Age Sex Outcome Treatment
    1