BEUDAMED
    FDA Adverse Event Death Summary report: N

    EGIA 60 ARTICULATING MED/THICK SULU

    MDR report key: 3775645 · Received April 15, 2014

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    Report

    Report Number
    1219930-2014-00305
    Event Type
    Death
    Date Received
    April 15, 2014
    Date of Event
    March 29, 2012
    Report Date
    March 28, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: THORACOSCOPY LEFT LUNGER UPPER LOBE WITH EXCISION MASS. ACCORDING TO THE REPORTER: WHILE PERFORMING A THORACOSCOPY TO REMOVE A PULMONARY NODULE IN THE LEFT UPPER LOBE OF THE LUNG, THE STAPLER PUNCTURED A BRANCH OF THE PULMONARY ARTERY. THIS LED TO BRISK BLEEDING AND THE LOSS OF UP TO 2 UNITS OF BLOOD ALMOST IMMEDIATELY. ANESTHESIA CONFIRMED MINIMAL INJECTION AND NO BLOOD PRESSURE. THE STAPLER HAD BEEN FIRED AT LEAST 7 TIMES BEFORE THE VASCULAR LACERATIONS WERE DISCOVERED. THE PT EXPIRED ON THE OPERATING ROOM TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230962 EGIA 60 ARTICULATING MED/THICK SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death