BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR

    MDR report key: 1053104 · Received May 16, 2008

    Report

    Report Number
    1053104
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 16, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE STAPLER, IT MISFIRED ON THE THIRD FIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAR STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *