BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO-GIA

    MDR report key: 1113084 · Received July 30, 2008

    Report

    Report Number
    1113084
    Event Type
    Malfunction
    Date Received
    July 30, 2008
    Date of Event
    September 26, 2007
    Report Date
    July 30, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN FOR SCHEDULED SURGERY , FOR LAPAROSCOPY DUE TO COMPLAINT OF PAIN. ACCORDING TO THE SURGERY DICTATION, THERE WAS A MISFIRING OF A STAPLER DEVICE. THIS WAS NOTED DURING A RANDOM AUDIT. I SPOKE WITH THE STAFF INVOLVED, THEY DO NOT REMEMBER THE EVENTS OF THIS CASE. ACCORDING TO THE OPERATIVE REPORT A "VASCULAR-ENDO-GIA WAS USED TO TRANSECT THE MESOAPPENDIX. THIS WAS DONE WITH TWO STAPLERS. A THIRD WAS USED BECAUSE THE SECOND MISFIRED, SPILLING A FEW UNFIRED STAPLES INTO THE ABDOMEN. SUCTION IRRIGATION WAS USED. THERE WAS NOTED SOME FREE STAPLES WERE SPILLED IN THE ABDOMEN. IN CHECKING TO SEE WHAT STAPLE DEVICE WAS USED I WAS TOLD THAT THREE ETHICON ETS-45-2.5 STAPLERS WERE USED. THIS IS A VAGUE REFERENCE NUMBER, WHICH COULD BE ONE OF THREE PRODUCTS ON OUR SHELVES: ATW45, OR TSW45, OR SCW45. MOSTLY LIKELY, IT WOULD BE THE FIRST, ALTHOUGH THERE IS NO WAY TO KNOW FOR SURE AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO-GIA STAPLER, SURGICAL GDW ETHICON, INC. ATW45 *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR