BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DST, EEA, XL

    MDR report key: 1003940 · Received February 1, 2008

    Report

    Report Number
    1003940
    Event Type
    Malfunction
    Date Received
    February 1, 2008
    Date of Event
    January 17, 2008
    Report Date
    January 31, 2008
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    FIRED AN ENDO GIA STAPLER 60, 3.5. WHEN REMOVING THE STAPLER A PIECE OF METAL CAME LOOSE AND PULLED AWAY FROM THE STAPLER. THE EEA 25MM STAPLER WAS DEFECTIVE. THE RING FELL OFF AROUND THE ANVIL PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DST, EEA, XL STAPLER, SURGICAL GAG COVIDIEN UNITED STATES SURGICAL CORPORATION * U7H16

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR