BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX

    MDR report key: 2170750 · Received July 19, 2011

    Report

    Report Number
    2170750
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE ENDO-GIA STAPLER USED FOR THIS CASE MISFIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. ATW35 H43P09

    Patients

    Seq Age Sex Outcome Treatment
    1 *