BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL STAPLER

    MDR report key: 5270611 · Received December 7, 2015

    Report

    Report Number
    2647580-2015-00866
    Event Type
    Injury
    Date Received
    December 7, 2015
    Date of Event
    November 16, 2015
    Report Date
    February 8, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE INSTRUMENT AND ONE LOADING UNIT BOTH OPENED BY THE ACCOUNT. MICROSCOPIC INSPECTION OF THE INSTRUMENT NOTED EVIDENCE ON THE FIRING ROD THAT THE LOADING UNIT WAS NOT ENGAGED PROPERLY WHEN LOADED. VISUAL EXAMINATION OF THE LOADING UNIT NOTED THAT IT WAS FULLY FIRED WITH THE JAWS CLAMPED AND THE KNIFE BAR ASSEMBLY ADVANCED TO THE EXTREME DISTAL END. THIS INDICATED THAT THE JAWS DID NOT OPEN WHEN THE INSTRUMENT RETURN KNOBS WERE RETRACTED. THIS PROVIDED FURTHER EVIDENCE THAT THE LOADING UNIT WAS NOT ENGAGED PROPERLY DURING LOADING. FUNCTIONALLY, THE INSTRUMENT WAS LOADED WITH PMV REPRESENTATIVE LOADING UNITS. THE INSTRUMENT SUCCESSFULLY, CLAMPED, CYCLED FULLY, OPENED AND UNLOADED REPEATEDLY WITHOUT DIFFICULTY. DURING FUNCTIONAL TESTING, THE LOADING UNIT WAS LOADED INTO THE SUBJECT AFTER MANUALLY OPENING THE JAWS. THE LOADING UNIT JAWS CLAMPED AND UNCLAMPED REPEATEDLY WITHOUT DIFFICULTY. THE INTERLOCK WAS OVERRIDDEN AND THE INSTRUMENT AND LOADING UNIT WERE CYCLED WITHOUT HESITATION OR BINDING. THE JAWS OPENED AFTER THE INSTRUMENT RETURN KNOBS WERE RETRACTED. FUNCTIONAL TESTING CONFIRMED THE SAFETY INTERLOCK FEATURE SUCCESSFULLY PREVENTED THE LOADING UNIT 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 LOADING UNIT 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). RESULTS PENDING COMPLETION OF EVALUATION.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A LOBECTOMY, THE STAPLER WAS FIRED, BUT WHEN ATTEMPTING TO OPEN BY PULLING BACK ON THE BLACK KNOBS, IT WOULD NOT OPEN AND REMAINED STUCK ON LUNG. ANOTHER DEVICE WAS APPLIED NEXT TO STUCK RELOAD AND FIRED SUCCESSFULLY TO RESOLVE THE SITUATION. NO ADVERSE EVENTS HAVE BEEN REPORTED. PATIENT IS CURRENTLY RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800136 EGIA ULTRA UNIVERSAL STAPLER STAPLE, IMPLANTABLE GDW COVIDIEN, FORMERLY USSC PUERTO RICO INC EGIAUSTND P5A0359X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention