BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 6999090 · Received November 3, 2017

    Report

    Report Number
    2647580-2017-07559
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    September 27, 2017
    Report Date
    January 9, 2018
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. VISUAL INSPECTION NOTED THAT THE RELOAD WAS PRE-FIRED AND ENGAGED IN INTERLOCK WITH THE JAWS OPEN. FUNCTIONAL TESTING OF THE RELOAD FOUND NO ABNORMALITIES, ALL STAPLES WERE PLACED AND THE TEST MEDIA WAS CLEANLY TRANSACTED. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE PRE-FIRE CONDITION WITH INTERLOCK ENGAGEMENT MAY OCCUR IF THE INSTRUMENT FIRING HANDLE HAD BEEN PARTIALLY COMPRESSED AND RELEASED AFTER PRESSING THE GREEN FIRING BUTTON. IN THIS SITUATION, THE SAFETY INTERLOCK FEATURE WILL ENGAGE AND PREVENT THE RELOAD FROM FIRING A SECOND TIME BY CEASING THE PLACEMENT OF STAPLES AND TISSUE TRANSECTION, AND PREVENT PATIENT HARM.THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: OCCURRED DURING A THORACO/LOBECTOMY. THE HANDLE AND RELOAD WERE ABLE TO BE SUCCESSFULLY CONNECTED AND THE RELOAD TEST WAS PREFORMED SUCCESSFULLY. WHEN THE SURGEON CLAMPED THE TISSUE AND TRIED TO FIRE THE DEVICE HE COULD NOT SQUEEZE THE HANDLE. HE TRIED AGAIN AND THE SAME ISSUE OCCURRED. THE CASE WAS COMPLETED USING A NEW DEVICE. PATIENT STATUS IS ALIVE, NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780868 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA60AMT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1