BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 6979875 · Received October 26, 2017

    Report

    Report Number
    1219930-2017-08279
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Date of Event
    October 2, 2017
    Report Date
    December 14, 2017
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    20884523003151
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. VISUAL AND FUNCTIONAL EVALUATION OF THE RELOAD FOUND NO ABNORMALITIES. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL MANUFACTURING QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: OCCURRED DURING A THORACO/LOBECTOMY. THE FIRST FOUR FIRINGS OF THE STAPLER WERE SUCCESSFUL, HOWEVER, ON THE FIFTH FIRING THE JAWS WOULD NOT CLOSE. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. THE PRODUCT WAS NOT USED ON THE PATIENT. PATIENT STATUS IS ALIVE, NO INJURY.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: OCCURRED DURING A THORACO/LOBECTOMY. THE FIRST FOUR FIRINGS OF THE STAPLER WERE SUCCESSFUL. HOWEVER, ON THE FIFTH FIRING, THE JAWS WOULD NOT CLOSE. THE HANDLE WAS ABLE TO BE SQUEEZED. SOMETIMES THE JAWS CLOSED BUT SOMETIMES THE JAWS DID NOT CLOSE. THE NURSE DID NOT PRESS GREEN BUTTON. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND RELOAD. THE PRODUCT WAS NOT USED ON THE PATIENT. PATIENT STATUS IS ALIVE, NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758910 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA45AMT N7F1139KX 20884523003151

    Patients

    Seq Age Sex Outcome Treatment
    1