BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL SHORT STAPLER

    MDR report key: 3011031 · Received March 11, 2013

    Report

    Report Number
    1219930-2013-00184
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 15, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    GDW
    PMA / PMN Number
    K083519
    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 TYPE: LUNG RESECTION. ACCORDING TO THE REPORTER: NEOVEIL, THE REINFORCEMENT MATERIAL WAS ATTACHED TO PURPLE CARTRIDGE TO PERFORM FIRING. AT THE 2ND FIRING, THE DEVICE MADE A LOUD CRACK AND THE HANDLE COULD NOT BE SQUEEZED AFTER THE DEVICE WAS FIRED ABOUT 1 CM. THE SURGEON OPENED A NEW STAPLER AND A BLACK CARTRIDGE AND TRIED FIRING WITHOUT THE REINFORCEMENT MATERIAL, BUT STILL THE HANDLE STOPPED AT THE SAME POINT. THIRD STAPLER AND THIRD CARTRIDGE WERE OPENED, BUT THE RESULT WAS THE SAME. THE SURGEON OPENED ANOTHER NEW DEVICE AND GRASPED THE TISSUE FROM THE OPPOSITE SIDE. FIRING WAS COMPLETED WITHOUT PROBLEM AFTER THAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102597 EGIA ULTRA UNIVERSAL SHORT STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SUR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EGIA 60 ARTICULATING MED/THICK SULU: (B)(4)| LOT #UNK, K083519