BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA UNIVERSAL

    MDR report key: 3042007 · Received April 2, 2013

    Report

    Report Number
    1219930-2013-00217
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 6, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LUNG RESECTION. ACCORDING TO THE REPORTER: WHEN THE SURGEON WANTED TO USE THE DEVICE ON THE LUNG, IT WOULD NOT CUT AND STAYED SHUT ON TISSUE. THE SURGEON HAD TO CUT THE TISSUE WITH A COLD BISTOURY TO REMOVE THE DEVICE. THE DEVICE WAS USED WITH A SEAMGUARD HANDLE SIZE 45.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134912 GIA UNIVERSAL DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N2J0439X

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability