BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYCO HEALTHCARE

    MDR report key: 1908956 · Received November 22, 2010

    Report

    Report Number
    MW5018314
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 22, 2010
    Manufacturer
    COVIDIEN
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY. AFTER THE FIRST FIRING OF THE AUTOSUTURE ENDO CLIP 5MM, METAL SHAVINGS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYCO HEALTHCARE AUTOSUTURE ENDO CLIP 5MM GDO COVIDIEN NOJO225

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR