BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3885292 · Received June 19, 2014

    Report

    Report Number
    3005075853-2014-04169
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE ANALYSIS FOUND THAT ONE PLE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH AN ECR60G RELOAD PRESENT. 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 1/4. 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. FURTHERMORE, THE CARTRIDGE PAN WAS NOTED TO BE DETACHED AT RIGHT PROXIMAL SIDE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE THE FIRST FIRING WAS WITH A BLACK RELOAD. ON THE SECOND FIRING WITH A GREEN RELOAD, THE STAPLER COMPLETED THE CYCLE. ON RELEASE IT WAS FOUND THAT THE CUTLINE WAS COMPLETE, BUT THE STAPLES ON THE PATIENT SIDE WERE NOT FORMED. IN THE FIRST ROW ALL OF THE STAPLES WERE ALL OK. IN THE SECOND ROW ABOUT HALF OF THE STAPLES WERE STILL STANDING UP (DID NOT FORM INTO BS). IN THE THIRD ROW ABOUT ¾ OF THE STAPLES WERE STILL STANDING UP (DID NOT FORM INTO BS). THE STAPLE LINE WAS OVER-SEWN WITH VICRYL SUTURE. ANOTHER GREEN RELOAD WAS USED TO COMPLETE THE CASE WITH THIS SAME STAPLER. SEAMGUARD WAS USED ON ALL FIRINGS. THE CASE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ONE DEVICE AND ONE RELOAD WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361149 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60G