BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDO GIA ROTICULATOR 45-2.5 SULU

    MDR report key: 2123012 · Received June 7, 2011

    Report

    Report Number
    1219930-2011-00450
    Event Type
    Death
    Date Received
    June 7, 2011
    Date of Event
    March 18, 2011
    Report Date
    May 25, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: PNEUMONECTOMY. ACCORDING TO THE REPORTER: FOLLOWING A POST LEFT SIDE PNEUMONECTOMY VIA THORACOTOMY APPROACH, EPIDERMAL WAS BEING RE-SITED WHEN LOSS OF BLOOD PRESSURE AND CARDIAC OUTPUT WAS NOTED. RESUSCITATION WAS ATTEMPTED BEFORE THE SURGEON RE-OPENED THE CHEST. PARTIAL STAPLE LINE DEHISCENCE WAS OBSERVED A SHORT TIME AFTER FIRING. WHEN THE VASCULAR CARTRIDGE IS FIRED FLUSH WITH THE PERICARDIUM, AS IN THIS CASE, THERE MAY HAVE BEEN EXCESS TENSION ON THE STAPLE LINE. THE EVENT WAS CLASSIFIED AS AN UNAVOIDABLE DEATH. DEHISCENCE OF THE STAPLE LINE MAY HAVE BEEN A CONTRIBUTORY FACTOR, BUT NOT NECESSARILY THE DIRECT CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 45-2.5 SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Death