BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 45-2.5 DLU

    MDR report key: 2821361 · Received October 25, 2012

    Report

    Report Number
    2647580-2012-00687
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 3, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: VIDEO-ASSISTED THORACOSCOPIC LEFT UPPER LOBECTOMY. ACCORDING TO THE REPORTER: WHEN THE SURGEON CUT THE PULMONARY VEIN, IT FAILED TO CLOSE. IT WAS FOUND THAT THE I-BEAM METAL PLATE WAS NOT PRESENT. NEW DEVICE OF SAME KIND WAS REPLACED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA II 45-2.5 DLU NONE GDW COVIDIEN, FORMERLY USSC PUERTO RICO P1E1345X

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other