BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDO GIA* TRI-STAPLE RR 60MM ET RELOAD

    MDR report key: 5259528 · Received December 1, 2015

    Report

    Report Number
    1219930-2015-01034
    Event Type
    Death
    Date Received
    December 1, 2015
    Date of Event
    November 6, 2015
    Report Date
    December 10, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K133938
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER: (B)(4). EVALUATION SUMMARY POST MARKET VIGILANCE (PMV) CONCURRENTLY WITH ENGINEERING LED AN EVALUATION OF ONE RELOAD, ONE STAPLER AND ONE BAG. VISUAL INSPECTION OF THE BAG NOTED THAT IT APPEARED TO CONTAIN TWO BROKEN INSTRUMENT FIRING RACK TEETH. INITIAL VISUAL INSPECTION OF THE INSTRUMENT NOTED THAT THE ARTICULATION KNOB WAS IN NEUTRAL POSITION AND THE FIRING KNOBS WERE IN NEUTRAL POSITION. VISUAL INSPECTION OF THE CARTRIDGE REVEALED THAT THE RELOAD WAS FULLY FIRED. THE JAWS OF THE RELOAD WERE OPEN. NO BUTTRESS MATERIAL WAS RECEIVED. THE PROXIMAL ANVIL AND CARTRIDGE SIDE SUTURES WERE CUT. THE DISTAL ANVIL AND CARTRIDGE SIDE SUTURES WERE BOTH RELEASED. MICROSCOPIC EVALUATION NOTED THAT THE RELOAD HAD DAMAGE TO THE CUTTING EDGE OF THE KNIFE BLADE. FUNCTIONALLY, THE INSTRUMENT WAS LOADED WITH A POST MARKET VIGILANCE (PMV) REPRESENTATIVE RELOAD. DURING THE FIRING CYCLE, TWO SKIPS WERE AUDIBLE IN THE FIRING STROKE. THE INSTRUMENT WAS DISMANTLED FOR VISUALIZATION OF INTERNAL COMPONENTS, AND TWO SHEARED TEETH WERE OBSERVED ON THE FIRING RACK. THE RELOAD WAS LOADED INTO A POST MARKET VIGILANCE (PMV) INSTRUMENT FOR FUNCTIONAL TESTING. THE RELOAD WAS CYCLED WITHOUT HESITATION OR BINDING. FUNCTIONAL TESTING CONFIRMED THE SAFETY INTERLOCK FEATURE SUCCESSFULLY PREVENTED THE RELOAD FROM CYCLING AGAIN. A REVIEW OF THE INSTRUMENT DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. A REVIEW OF THE RELOAD DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL MEDTRONIC 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A WEDGE RESECTION, THE SURGEON FIRED A REINFORCED RELOAD. IN THE MIDDLE OF FIRING, THE GEAR OF THE HANDLE WAS BROKEN. THE DEVICE WAS RELEASED FROM THE TISSUE AFTER THE FIRING WAS DONE. A NEW HANDLE WAS OPENED TO CORRECT THE PROBLEM. THE TISSUE WAS THICK. ABOUT 2 OR 3 HOURS LATER, THE PATIENT CONDITION SUDDENLY CHANGED AND THE PATIENT DIED FROM AN UNKNOWN CAUSE. ON FURTHER DISCUSSIONS WITH THE SURGEON, HE INDICATED THAT THERE WAS NO DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787257 ENDO GIA* TRI-STAPLE RR 60MM ET RELOAD STAPLE, IMPLANTABLE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIATRS60AXT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death