BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3042880 · Received April 9, 2013

    Report

    Report Number
    3005075853-2013-01660
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND ONE RELOAD LOADED IN THE DEVICE AND THE OTHER ONE RECEIVED IN A SEPARATE BAG. THE RELOADS WERE RECEIVED FULLY FIRED. 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. THE EVENT COULD NOT BE CONFIRMED AS NO MALFORMED STAPLES WERE NOTED DURING FUNCTIONAL TESTING. IN ADDITION THE RETURNED RELOADS WERE DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND NO ANOMALIES WERE NOTED. A VIDEO OF THE PROCEDURE WAS ALSO RECEIVED FOR REVIEW. BASED ON THE OBSERVATIONS, THERE MAY HAVE BEEN SOME TISSUE SQUEEZE OUT / TISSUE MOVEMENT AS THE THREE POINT GAP CONTROL WAS BRING THE TISSUE INTO THICKNESS COMPLIANCE, RESULTING IN THE TWO STRAIGHT LEG STAPLES. HOWEVER THIS COULD NOT BE CONFIRMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INTRA OPERATIVE VIDEO WAS RECEIVED. UPON REVIEW OF THE VIDEO, A POTENTIAL CAUSE OF THE REPORTED EVENT IS THE TISSUE MAY HAVE PUSHED OUT OR MOVED FROM THE JAWS OF THE DEVICE RESULTING IN THE TWO UNFORMED STAPLES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, THE FIRST FIRING ON THE STOMACH WAS DONE WITH A BLACK CARTRIDGE. FOLLOWING RECOMMENDED FIRING STEPS TO HELP IN THICK TISSUE AND UNFORTUNATELY SEVERAL STRAIGHT LEGGED STAPLES WERE STILL REMOVED FROM THIS STAPLE LINE ON INTERIOR LINE PATIENT SIDE. THE REMAINDER OF THE CASE WAS COMPLETED WITH THE SAME STAPLER AND GREEN RELOADS WHICH WERE FINE. THE AREA THAT HAD MALFORMED STAPLES WAS OVER SEWN AND THE OMENTUM WAS BROUGHT OVER AS PATCH AS WELL TO THE BUTTRESS AREA THAT STRAIGHT LEGGED STAPLES WERE FOUND IN. THIS ADDED TIME TO THE CASE AND EXTRA ANESTHESIA FOR THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146076 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-ECR60T