BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 45-2.0 SULU

    MDR report key: 1822815 · Received August 30, 2010

    Report

    Report Number
    1219930-2010-00680
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 24, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: LOBECTOMY. ACCORDING TO THE REPORTER: THE PULMONARY ARTERY "GOT LOOSEN" AT THE EXTUBATION OF THE PATIENT. THE PATIENT RETURNED TO THE OPERATING ROOM. THE THORAX WAS OPENED AND THE SURGEON NOTED THAT THE STAPLE LINE DID NOT HOLD. FOUR LITERS OF BLOOD WERE TRANSFUSED AND THE VESSEL WAS SECURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 45-2.0 SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N9D0316

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention 030449, ENDO GIA UNIVERSAL 12MM SINGLE USE INST