BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA UNIVERSAL ROTICULATOR

    MDR report key: 1960037 · Received December 29, 2010

    Report

    Report Number
    1960037
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    November 24, 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

    VASCULAR RELOAD USED ON SEGMENTAL PULMONARY ARTERY DID NOT RELEASE. VESSEL HAD TO BE TIED OFF AND LIGATED ABOVE AND BELOW STAPLER BY SURGEON. ANOTHER STAPLER RELOAD WAS PLACED ON STAPLER AND WORKED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL ROTICULATOR STAPLER, RELOAD, SURGICAL GDW COVIDIEN * N0H0201

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR