BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTIFIRE ENDO GIA 30-2.5 (V) DLU

    MDR report key: 1771048 · Received July 21, 2010

    Report

    Report Number
    2647580-2010-00626
    Event Type
    Death
    Date Received
    July 21, 2010
    Date of Event
    May 6, 2010
    Report Date
    July 2, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K900129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    PROCEDURE: VATS. ACCORDING TO THE REPORTER: A VATS SEGMENTAL RESECTION OF LUNG AND THORACOSCOPY WAS PERFORMED ON THE PT. TWO HOURS AFTER THE SURGERY WAS FINISHED, THE PT COUGHED, AND BLEEDING OF OVER 500CC OCCURRED IN THE CHEST CAVITY. THE REPORT STATED THAT THE INCIDENT WAS CAUSED BY THE STUMP OF THE DISSECTED BRONCHIOLE TOUCHING THE PULMONARY VEIN AT V6 (V6 REFERS TO THE PRECISE PART OF THE VEIN). THE BRONCHIOLE WAS STAPLED BY THE DEVICE. THE PT EXPIRED ON (B) (6)2010. THE AUTOPSY STATED THAT THE CAUSE OF DEATH WAS CYSTIC MEDIAL NECROSIS (ANEURYSM). THE SURGEON STATED THE INCIDENT WAS NOT CAUSED BY THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIFIRE ENDO GIA 30-2.5 (V) DLU DISPOSABLE STAPLER GDW USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death