BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 1830820 · Received April 21, 2010

    Report

    Report Number
    1830820
    Event Type
    Malfunction
    Date Received
    April 21, 2010
    Date of Event
    April 13, 2010
    Report Date
    April 21, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    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

    MISFIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, LLC. * G4RR1V

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR