BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH LINEAR CUTTER RELOAD, BLACK

    MDR report key: 3954626 · Received July 14, 2014

    Report

    Report Number
    3954626
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 14, 2014
    Manufacturer
    ETHICON ENDOSURGERY
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SECOND FIRE (BLACK RELOAD) MISFIRED. THIRD FIRE (GREEN RELOAD) MISFIRED. DEPLOYED PARTIAL STAPLE LINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410016 ENDOPATH LINEAR CUTTER RELOAD, BLACK STAPLE, IMPLANTABLE, RELOAD GDW ETHICON ENDOSURGERY * L52U2R
    410017 ECHELON ENDOPATH LINEAR CUTTER RELOAD, GREEN STAPLE, IMPLANTABLE, RELOAD GDW ETHICON ENDOSURGERY * L52W6M
    410018 ECHELON ENDOPATH 45 LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDOSURGERY * L4EA93

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR STAPLER