BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGIA 60 ARTICULATING MED/THICK SULU

    MDR report key: 3192521 · Received June 19, 2013

    Report

    Report Number
    1219930-2013-00452
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LUNG RESECTION. ACCORDING TO THE REPORTER: WHEN INSERTING THE IDRVULTRA HANDLE WITH THE EGIA60AMT SULU IN THE INTERCOSTAL AREA AND MAKING AN APPROXIMATION IN ORDER TO CATCH LUNG TISSUE BETWEEN THE JAWS, THE SYSTEM CREAKED. THE SURGEON REMOVED IT OUT OF THE PT TO CHECK AND THEY SAW THAT THE SULU WAS SLIGHTLY BENT IN THE AREA THAT CONNECTS WITH THE ADAPTER. THE DEVICE HAD NOT BEEN STAPLED BEFORE. IN ORDER TO GO ON WITH THE SURGERY, THEY USED ANOTHER SULU IN AN EGIAUSHORT, WHICH WORKED CORRECTLY. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS. NO REINFORCEMENT MATERIAL USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278869 EGIA 60 ARTICULATING MED/THICK SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N3C03748LX

    Patients

    Seq Age Sex Outcome Treatment
    1 EXP DATE 03/31/2018, PMA/510K K083519| LOT # C2012K049, MFR DATE 03/2013,| ENDO GIA ADAPTER STANDARD, CAT # EGIAADAPT,