BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 4091582 · Received September 16, 2014

    Report

    Report Number
    3005075853-2014-06435
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 8, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE PLE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH AN ECR60G LOADED IN THE DEVICE. ADDITIONALLY, THE RELOAD WAS RECEIVED WITH THE RIGHT SIDE FULLY FIRED, LEFT SIDE OUTER ROW FULLY FIRED AND THE LEFT TWO INNER ROWS PARTIALLY FIRED 1/6. UPON EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED. NO OBVIOUS DAMAGE TO THE CARTRIDGE DECK WAS NOTED, WHICH SUGGESTS THE CARTRIDGE, MAY NOT HAVE BEEN FIRED OVER A HARD OBJECT. AS ADDITIONAL TESTING, THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. HOWEVER, THE CUT WAS NOTED TO BE JAGGED DUE TO A DAMAGED KNIFE. ONE POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE TO THE KNIFE IS WHEN THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE, HARD OBJECT OR THICKER TISSUE THAN INDICATED. REPEATEDLY FIRING ACROSS EXISTING STAPLE LINES CAN ALSO REDUCE THE ABILITY TO CUT CLEANLY. TO MITIGATE THE POTENTIAL FOR STAPLES GETTING INTO THE CARTRIDGE AND INTERFERING WITH THE KNIFE PATH DURING DEVICE FIRING, PRIOR TO RELOADING THE DEVICE, RINSE THE ANVIL AND CARTRIDGE JAW IN STERILE SOLUTION AND THEN WIPE THE ANVIL AND CARTRIDGE JAW TO CLEAN ANY FORMED BUT UNUSED STAPLES FROM THE DEVICE. ADDITIONALLY, PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED, TO ENSURE THAT NO HARD OBSTRUCTION SUCH AS A CLIP IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, THE GUN LOCKED ON THE SECOND FIRING, GREEN RELOAD. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH ANOTHER RELOAD OF THE SAME PRODUCT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571264 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK L4EW8W

    Patients

    Seq Age Sex Outcome Treatment
    1