BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 6958507 · Received October 18, 2017

    Report

    Report Number
    1219930-2017-08048
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    January 6, 2017
    Report Date
    October 18, 2017
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. VISUAL INSPECTION OF THE CARTRIDGE REVEALED THAT THE LOADING UNIT WAS PARTIALLY FIRED. THE ANVIL OF THE LOADING UNIT WAS SEVERELY BOWED AND THE KNIFE BAR ASSEMBLY WAS BUCKLED. DUE TO THE NOTED DAMAGE NO FUNCTIONAL TESTING WAS PERFORMED ON THE LOADING UNIT. 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 BOWED ANVIL, DEFORMED ANVIL CLAMPING MECHANISM, AND BUCKLED KNIFE-BAR ASSEMBLY MAY OCCUR UNDER THE FOLLOWING CONDITIONS: FIRING OVER TISSUE THAT IS BEYOND THE RECOMMENDED THICKNESS RANGE, FIRING WITH AN OBSTACLE INCORPORATED IN THE JAWS. IN EITHER OF THESE CIRCUMSTANCES, IT WILL BECOME INCREASINGLY DIFFICULT TO ACTUATE THE FIRING HANDLE AND THE INSTRUMENT RETURN KNOBS WILL BE DIFFICULT TO RETRACT. IN ADDITION, STAPLES MAY NOT FORM PROPERLY AND TISSUE MAY NOT BE FULLY TRANSECTED. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING THE PROCEDURE VATS LOBECTOMY. THE STAPLER CAN'T WORK WELL (WIDTH OF JAW OPENING IS SMALLER THAN USUAL) WHEN SURGEON RESECTION THE LOBE. SO THE SURGEON CHANGED TO A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737989 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN 030458

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR