BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EEA 31

    MDR report key: 1980033 · Received February 1, 2011

    Report

    Report Number
    MW5019240
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 22, 2011
    Report Date
    February 1, 2011
    Manufacturer
    COVIDIEN/TYCO
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A 31 MM EEA STAPLER FROM COVIDIEN MISFIRED. REP HAS BEEN NOTIFIED. NO ADVERSE EVENT EXCEPT SURGERY TIME EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 31 EEA 31MM STAPLER GDW COVIDIEN/TYCO U8E69H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other