BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45

    MDR report key: 2082689 · Received May 3, 2011

    Report

    Report Number
    2082689
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 4, 2011
    Report Date
    May 3, 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

    DEVICE WAS MAKING NOISE AND MISFIRED, THEN QUIT WORKING ALTOGETHER. NEW DEVICE (SAME) WAS USED TO COMPLETE PROCEDURE. NO PATIENT HARM. OR STAFF IS CONTACTING REPRESENTATIVE TO COME GET THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 STAPLER, CUTTER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. ATS45 H4371C

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR