BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON

    MDR report key: 2993166 · Received February 26, 2013

    Report

    Report Number
    MW5029200
    Event Type
    Injury
    Date Received
    February 26, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ETHICON
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MALFUNCTION OF ETHICON FLEX 60 STAPLER. WOULD NOT RELEASE AFTER FIRING, REQUIRING MANUAL OVERRIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81460 ETHICON ECHELON FLEX 60 ENDOPATH STAPLER GDW ETHICON J4A47E

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention