BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 60-2.5 SULU

    MDR report key: 1221923 · Received November 4, 2008

    Report

    Report Number
    1219930-2008-00805
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 23, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LOBECTOMY. ACCORDING TO THE REPORTER: STAPLES DID NOT FORM PROPERLY. BLOOD LOSS WAS REPORTED AS ONE LITER. THE PROCEDURE WAS CONTINUED WITH ANOTHER INSTRUMENT, AND SURGERY TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 60-2.5 SULU DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS N7L98

    Patients

    Seq Age Sex Outcome Treatment
    1 Other