BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 3090602 · Received May 2, 2013

    Report

    Report Number
    3005075853-2013-02116
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 5, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. IT SHOULD BE NOTICE THAT TO FIRE THE DEVICE, DRAW THE RED SAFETY BACK TOWARD THE ADJUSTING KNOB UNTIL IT SEATS INTO THE BODY OF THE DEVICE. IF THE SAFETY CANNOT BE RELEASED, THE DEVICE IS NOT IN THE SAFE FIRING RANGE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN SIGMOIDECTOMY, THE SAFETY COULD NOT REMOVED BEFORE FIRING, BUT IT WAS REMOVED WITH FORCE. THE DEVICE WAS FIRED WHERE THE INDICATOR SHOWED WITHIN 1/3 GREEN SCALE. THE SAME DEVICE WAS USED AS IS TO COMPLETE THE CASE. ON THE SAME DAY AFTER THE OPERATION, LEAK WAS CONFIRMED. THE PATIENT HAD IN A STATE OF SHOCK A FEW DAYS AFTER LEAK. THE REOPERATION WAS PERFORMED ON (B)(6). AFTER ABOUT 1MM HOLE WAS CONFIRMED AND THE TARGET TISSUE WAS CUT, REANASTOMOSIS WAS PERFORMED WITH CDH. DAMAGE DEPENDING ON A DRAIN (MEDICON) WAS IDENTIFIED AS THE CAUSE OF LEAK. THERE WERE NO OTHER ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192343 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CK0A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention