BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL STAPLER

    MDR report key: 6017498 · Received October 11, 2016

    Report

    Report Number
    2647580-2016-00814
    Event Type
    Injury
    Date Received
    October 11, 2016
    Date of Event
    September 15, 2016
    Report Date
    September 16, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GDW
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE STAPLER AND ONE SINGLE USE LOADING UNIT BOTH OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A MEDICAL AND TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, ENGINEERING REVIEW OF THE PRODUCT AND AN EVALUATION OF THE RETURNED DEVICES. THE INSTRUMENT WAS RECEIVED ENGAGED WITH THE LOADING UNIT. VISUAL INSPECTION OF THE CARTRIDGE REVEALED THAT THE LOADING UNIT WAS PARTIALLY FIRED TO JUST PAST THE 2CM CUT LINE. THE LOADING UNIT WAS UNLOADED FROM THE INSTRUMENT WITHOUT DIFFICULT. ENGINEERING EVALUATED THE LOADING UNIT AND CONFIRMED THE PRESENCE OF STAPLE STRIKES ON BOTH THE LEFT AND THE RIGHT SIDE OF THE ANVIL. THE PRESENCE OF THESE STAPLE STRIKES IS INDICATIVE OF THE CARTRIDGE ASSEMBLY HAVING BEEN LOADED WITH A FULL COMPLEMENT OF STAPLES. FUNCTIONALLY, THE INSTRUMENT WAS LOADED WITH AN SINGLE USE LOADING UNIT. DURING TESTING OF THE INSTRUMENT A SKIP WAS NOTED IN THE FIRING STROKE AFTER CLOSURE OF THE LOADING UNIT JAWS. AN ACCESS HOLE WAS CUT INTO THE INSTRUMENT BODY FOR VISUALIZATION OF THE FIRING RACK. THIS EXAMINATION NOTED SHEARED TEETH ON THE ANTERIOR FIRING RACK. DURING FUNCTIONAL TESTING, THE LOADING UNIT WAS LOADED INTO A POST MARKET VIGILANCE INSTRUMENT. THE INTERLOCK WAS OVERRIDDEN AND THE LOADING UNIT WAS APPLIED TO TEST MEDIA, AND FOUND TO FUNCTION PROPERLY. ALL REMAINING STAPLES WERE PLACED AND TEST MEDIA WAS CLEANLY TRANSECTED. FUNCTIONAL TESTING CONFIRMED THE SAFETY INTERLOCK FEATURE SUCCESSFULLY PREVENTED THE LOADING UNIT FROM CYCLING AGAIN. DURING THIS INVESTIGATION, A SECONDARY CONDITION WAS IDENTIFIED AS FOLLOWS; THERE WERE SHEARED TEETH OBSERVED ON THE INSTRUMENT FIRING RACK. A REVIEW OF THE INSTRUMENT DEVICE HISTORY RECORDS INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. A REVIEW OF THE RELOAD DEVICE HISTORY RECORDS COULD NOT BE PERFORMED BECAUSE THE LOT NUMBERS WERE 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. REPLICATION OF THE SHEARED TEETH ON THE FIRING RACK MAY OCCUR IN ANY OF THE FOLLOWING CIRCUMSTANCES: 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. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING A HEPATOBILIARY PROCEDURE, THE STAPLER DID NOT FIRE CORRECTLY. IT DID NOT PLACE THE STAPLES, ONLY THE KNIFE BLADE IN THE RELOAD FIRED. RESULTED IN CUTTING WITHOUT STAPLING. BLEEDING OCCURRED IN ONGOING LIVER SURGERY. THE ISSUE WAS CORRECTED WITH SUTURES AND HEMOSTATIC PRODUCTS. THE PATIENT IS DOING ALRIGHT AND NO PERMANENT DAMAGE WAS DONE. NO REINFORCEMENT MATERIAL WAS USED IN CONJUNCTION WITH THE STAPLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668911 EGIA ULTRA UNIVERSAL STAPLER STAPLE, IMPLANTABLE GDW COVIDIEN, FORMERLY USSC PUERTO RICO INC EGIAUSTND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention