BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1202325 · Received October 16, 2008

    Report

    Report Number
    MW5008633
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 16, 2008
    Report Date
    October 16, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON THE STAPLE LINE AT THE ANGLE OF HISS THERE WAS A MISFIRING OF THE STAPLER. STAPLES DID NOT FORM CORRECTLY, ALTHOUGH THERE WAS NO OBVIOUS HOLE. WE MADE SURE THAT THE TUBE WAS COMPLETELY REMOVED AND INTACT THEN CUT BOTH STAPLE LINES OUT ON EACH SIDE OF THE STOMACH, FIRST THE POUCH SIDE, THEN THE REMNANT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLER STAPLER GDW ETHICON ENDO-SURGERY, INC. E4KR7N

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR