BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX

    MDR report key: 2250768 · Received September 5, 2011

    Report

    Report Number
    2250768
    Event Type
    Malfunction
    Date Received
    September 5, 2011
    Date of Event
    August 4, 2011
    Report Date
    September 5, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MISFIRED.MANUFACTURER RESPONSE FOR STAPLER, SURGICAL, ETS FLEX (PER SITE REPORTER): DEVICE GIVEN TO REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. ATS45 H43U92
    2 * INSTRUMENT, ULTRASONIC SURGICAL, CURVED SHEARS LFL ETHICON ENDO-SURGERY, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR