BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY, INC.

    MDR report key: 564431 · Received November 24, 2004

    Report

    Report Number
    MW1034145
    Event Type
    Malfunction
    Date Received
    November 24, 2004
    Date of Event
    November 18, 2004
    Report Date
    November 23, 2004
    Manufacturer
    ETHICON ENDO-SURGRY, INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAPLER FAILED TO FIRE ON PULMONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, INC. RELOADABLE VASCULAR LINEAR STAPLER KOG ETHICON ENDO-SURGRY, INC. 1 PROXIMATE U4032J

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR