BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIUM SURGICLIP

    MDR report key: 1903488 · Received November 2, 2010

    Report

    Report Number
    1903488
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 4, 2010
    Report Date
    November 2, 2010
    Manufacturer
    COVIDIEN
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED TO FIRE PREMIUM SURGICLIP MEDIUM 9.75" CLIP APPLIER, IT WOULD NOT FIRE. ATTEMPTED TO USE A SECOND SURGICLIP MEDIUM 9.75", IT WOULD NOT FIRE EITHER. STAPLES WERE THEN ADVANCED MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM SURGICLIP CLIP APPLIER GDO COVIDIEN * POF0975
    2 PREMIUM SURGICLIP CLIP APPLIER GDO COVIDIEN * POF0345

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR