BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA UNIVERSAL

    MDR report key: 3800312 · Received May 2, 2014

    Report

    Report Number
    1219930-2014-00344
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 9, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K900129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOBECTOMY. ACCORDING TO THE REPORTER: WHEN THE MECHANISM WAS TO BE REOPENED WITH THE PATHOLOGY PIECE INSIDE, THE MECHANISM DID NOT OPEN TO RELEASE THE PATHOLOGY PIECE. THE CARTRIDGE WAS STUCK ON TISSUE AND DID NOT OPEN. USED ANOTHER DEVICE WITHOUT FURTHER CONSEQUENCE. MEDICAL INTERVENTION REQUIRED: FIRED A SECOND LOAD NEXT TO THE FIRST, TAKING MORE LUNG. UNANTICIPATED TISSUE LOSS: 12MM EXTRA TISSUE. NO REINFORCEMENT MATERIAL USED. NOTHING FELL IN THE SURGICAL CAVITY. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. PATIENT CURRENT STATUS REPORTED AS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263793 GIA UNIVERSAL DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N3M0859X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EGIA60AXT, LOT #N3L1146GX, K093410| MANUFACTURING DATE:11/2013, EXP DATE: 11/30/2018| EGIA 60 ARTICULATING XTRA THICK SULU