BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS

    MDR report key: 2250839 · Received September 2, 2011

    Report

    Report Number
    2250839
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    December 14, 2010
    Report Date
    September 2, 2011
    Manufacturer
    ETHICON ENDO SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDOSCOPIC STAPLER MALFUNCTION DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS STAPLER, SURGICAL GDW ETHICON ENDO SURGERY, INC. TSB35 A93015

    Patients

    Seq Age Sex Outcome Treatment
    1 *