BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 7140978 · Received December 21, 2017

    Report

    Report Number
    1219930-2017-10354
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    December 6, 2017
    Report Date
    January 26, 2018
    Manufacturer
    COVIDIEN NORTH HAVEN-MFG
    Product Code
    GDW
    UDI-DI
    10884521543720
    PMA / PMN Number
    K160176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE IMAGE AND FOUR DEVICES. THE VISUAL INSPECTION AND FUNCTIONAL EVALUATION OF THE DEVICE HAD ACCEPTABLE RESULTS. THE IMAGE NOTED A SECTION OF THE STAPLE LINE, THREE STAPLES WERE VISIBLE. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. 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 LEFT THORACOTOMY AND LOBECTOMY. DURING THE SECOND FIRING ON THE VESSEL, THE DEVICE HAD POOR STAPLE FORMATION. THE PHYSICIAN FELT THAT SOME STAPLES WERE NOT FORMED PROPERLY. THERE WAS NOTHING ADDITIONAL NEEDED TO COMPLETE THE CASE. THE SURGEON PROCEEDED THE CASE AS NORMAL. HE JUST NOTICED A FEW STAPLES THAT DIDN'T LOOK FORMED CORRECTLY. THERE WAS NO LEAK OR ANYTHING LIKE THAT OR DELAY IN TIME. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920138 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN NORTH HAVEN-MFG SIG45CTAVM N7D0786X 10884521543720

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR