BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS 45

    MDR report key: 3220841 · Received July 8, 2013

    Report

    Report Number
    3220841
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    August 8, 2012
    Report Date
    July 8, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WHEN SURGEON PRESSED THE HANDLE TO FIRE THE STAPLER LOAD, THE DEVICE WOULD NOT FIRE AND WAS MAKING NOISES.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?DIAGNOSTIC LAPAROSCOPY, APPENDECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311432 ENDOPATH ETS 45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, INC. ETS 45 J4AY4T

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR NO OTHER THERAPIES