BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 1426783 · Received July 22, 2009

    Report

    Report Number
    1426783
    Event Type
    Malfunction
    Date Received
    July 22, 2009
    Date of Event
    April 8, 2009
    Report Date
    July 22, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US

    Narratives

    Description of Event or Problem · 1

    STAPLER FAILED TO FIRE.MANUFACTURER RESPONSE (AS PER REPORTER) FOR STAPLER,SURGICAL, ENDOPATH ETS THEY WILL REPLACE AND SEND RETURN KIT. WILL ADVISE OF FINDINGS AFTER QA IS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. * E4LV22

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR