BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIFIRE ENDO GIA

    MDR report key: 1946364 · Received December 29, 2010

    Report

    Report Number
    1946364
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 20, 2010
    Report Date
    December 29, 2010
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    SURGEON USING A MULTIFIRE 30 ENDO GIA STAPLER WITH A VASCULAR LOAD ON A PULMONARY ARTERY; THE STAPLER FIRED, BUT DID NOT OPEN, CAUSING A TEAR IN THE PULMONARY ARTERY. TEAR WAS REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIFIRE ENDO GIA STAPLER, SURGICAL GDW COVIDIEN * P0J0051
    2 MULTIFIRE ENDO GIA STAPLER, RELOAD, SURGICAL GDW COVIDIEN * P0J0555

    Patients

    Seq Age Sex Outcome Treatment
    1 *