BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX

    MDR report key: 2250779 · Received September 6, 2011

    Report

    Report Number
    2250779
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    June 16, 2011
    Report Date
    August 23, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING THE ATS45 STAPLER WHEN THE DEVICE MADE A CRACKING SOUND AND WOULD NOT SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. ATS45 H43W33

    Patients

    Seq Age Sex Outcome Treatment
    1 *