BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA UNIVERSAL

    MDR report key: 2004423 · Received February 15, 2011

    Report

    Report Number
    2004423
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 15, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    WHEN THE PHYSICIAN FIRED THE FIRST LOAD, THE STAPLER FIRED SMOOTHLY. WHEN HE FIRED THE 2ND LOAD, IT WENT 3/4 OF THE WAY AND STOPPED. THERE WAS A LOUD CRACKING NOISE THAT SOUNDED LIKE THE STAPLER HANDLE BROKE. AT THAT POINT, PHYSICIAN COULD NOT ENGAGE THE HANDLE TO CONTINUE TO FIRE STAPLES. AFTER MANIPULATING THE HANDLE FOR AWHILE AND PROVIDING HEMOSTASIS TO THE STAPLE LINE, THE HANDLE WAS REMOVED FROM THE PATIENT. A SECOND STAPLER WAS OPENED TO FINISH PROCEDURE.MANUFACTURER RESPONSE FOR STAPLER, SURGICAL, ENDO GIA UNIVERSAL:MANUFACTURER PROVIDED RGA AND PACKING MATERIAL FOR PRODUCT RETURN EVALUATION.MANUFACTURER RESPONSE FOR STAPLER, RELOAD, SURGICAL, ENDO GIA ROTICULATOR: MANUFACTURER PROVIDED RGA AND PACKING MATERIAL FOR PRODUCT RETURN EVALUATION.MANUFACTURER RESPONSE FOR STAPLER, RELOAD, SURGICAL, ENDO GIA ROTICULATOR: MANUFACTURER PROVIDED RGA AND PACKING MATERIAL FOR PRODUCT RETURN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL STAPLER, SURGICAL GDW COVIDIEN EGIAUNIVXL N0G0032
    2 ENDO GIA ROTICULATOR STAPLER, RELOAD, SURGICAL GDW COVIDIEN 030454 N0J0239
    3 ENDO GIA ROTICULATOR STAPLER, RELOAD, SURGICAL GDW COVIDIEN 030454 N0G0313

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR