BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 4130040 · Received September 30, 2014

    Report

    Report Number
    3005075853-2014-06762
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 19, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. RELEASE BUTTON THE ANALYSIS FOUND THAT ONE PLE60A DEVICE WAS RECEIVED FOR ANALYSIS WITHOUT CARTRIDGE RELOAD. THE MANUAL OVERRIDE DOOR WAS NOTED TO BE OUT OF POSITION AND MISSING; THE OVERRIDE LEVER WAS UP WHICH DENOTES THAT THE KNIFE WAS MANUALLY RETURNED TO HOME POSITION. PLEASE NOTE IF THE INSTRUMENT IS PARTIALLY FIRED, SLIDE THE KNIFE REVERSE SWITCH FORWARD TO RETURN THE KNIFE TO HOME POSITION. IT SHOULD BE NOTED AFTER THE MANUAL OVERRIDE SYSTEM IS USED THE INSTRUMENT IS DISABLED AND CANNOT BE USED FOR ANY SUBSEQUENCE FIRINGS. FURTHERMORE, THE DEVICE WAS FOUND TO HAVE THE CLAMPING MECHANISM DAMAGED. DUE TO THE WEAR AND DAMAGE TO THE CLAMP RELEASE, IT APPEARS THAT THE DEVICE WAS FORCED OPEN WITH THE KNIFE NOT AT THE HOME POSITION. THE DEVICE WAS DISASSEMBLED TO RESET THE BAILOUT SYSTEM AND THEN, THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE DEVICE CLOSED, CYCLED AND OPENED 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 AN UNKNOWN PROCEDURE, THE DEVICE DID NOT FIRE AT THE FIRST FIRING. IT IS UNKNOWN WHAT COLOR CARTRIDGE WAS BEING USED. A SECOND DEVICE WAS PULLED AND THE SAME THING OCCURRED. A THIRD DEVICE WAS PULLED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608800 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK L4EY7Y

    Patients

    Seq Age Sex Outcome Treatment
    1 ASKU