BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 1242764 · Received November 17, 2008

    Report

    Report Number
    1242764
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    October 2, 2008
    Report Date
    November 17, 2008
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A VIDEO ASSISTED THORACOSCOPY WITH LOWER LOBE RESECTION. THE DISPOSABLE, AUTOSUTURE STAPLER WAS BEING USED. THIS WAS APPROPRIATELY THE 9TH RELOAD FOR THE GUN. THE RESIDENT WAS APPROXIMATING THE TISSUE INTO THE JAWS OF THE RELOAD AND WHEN CLOSING THE STAPLER'S JAWS, THE CLOSURE WAS NOT COMPLETE IN APPEARANCE. THE RESIDENT WAS MANIPULATING THE GUN, MOVING IT UP AND DOWN, AND SIDE TO SIDE WHEN A "CRACK" SOUND WAS HEARD. HE THEN PROCEEDED TO FIRE THE STAPLER AND ANOTHER "CRACK" SOUND WAS HEARD, LOUDER THAN BEFORE. IT WAS NOTED THAT THE STAPLER RELOAD HAD BROKE AND THE DEVICE COULD NOT BE REMOVED FROM THE LUNG TISSUE THROUGH THE SMALL INCISION THAT THEY WERE WORKING THROUGH. THE CASE HAD TO PROGRESS TO AN OPEN THORACOTOMY TO REMOVE THE STAPLER RELOAD AND SEW THE RESECTED AREA OF THE LUNG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA STAPLER, SURGICAL GDW COVIDIEN UNITED STATES SURGICAL CORPORATION * N8F444

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR