BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 60-4.8 SULU

    MDR report key: 3170095 · Received June 4, 2013

    Report

    Report Number
    2647580-2013-00313
    Event Type
    Injury
    Date Received
    June 4, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 27, 2013
    Manufacturer
    COVIDIEN
    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: LOBECTOMY. ACCORDING TO THE REPORTER: THE STAPLES ARE UNABLE TO FIRE. THE SURGEON TRIED SEVERAL TIMES UNTIL STAPLES DID FIRE HALF WAY. DAMAGED TISSUE WAS RESECTED WITH ANOTHER RELOAD. SURGERY TIME WAS EXTENDED BY MORE THAN 30 MINUTES WITHOUT ADVERSE EFFECT TO THE PATIENT. NO REINFORCEMENT MATERIAL WAS USED IN CONJUNCTION WITH THE STAPLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247593 ENDO GIA II 60-4.8 SULU NONE GDW COVIDIEN P0D0744

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Disability