BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 2220134 · Received August 23, 2011

    Report

    Report Number
    3005075853-2011-03449
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANVIL, CLOSURE TRIGGER TOP. THE ANALYSIS RESULTS FOUND THAT ONE (B)(4) DEVICE WAS RETURNED WITH THE ANVIL BENT UPWARDS AND WITH A WHITE CARTRIDGE RELOAD PRESENT. THE RELOAD WAS RECEIVED FULLY FIRED. THE CLAMPING MECHANISM WAS NOTED TO BE DAMAGED; THEREFORE NO FUNCTIONAL TEST WAS PERFORMED. THE DAMAGE TO THE ANVIL IS CONSISTENT WITH THE DEVICE BEING CLAMPED OVER AN EXCESS OF TISSUE CAUSING THE ANVIL TO BENT UPWARDS AND FOR THE FIRING MECHANISM TO FAIL. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTERNAL COMPONENTS AND THE CLOSURE TRIGGER TOP WAS NOTED TO BE DAMAGE. ONE POSSIBLE SCENARIO FOR THE DESCRIBED EVENT IS DUE TO APPLYING A LARGE PRYING FORCE ON THE CLOSURE TRIGGER HANDLE IN THE OPENING DIRECTION. THIS WILL RESULT IN DAMAGE TO THE CLOSURE TRIGGER TOP COMPONENT IF THE APPLIED LOAD IS HIGH ENOUGH. IT SHOULD BE NOTED THAT 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 AN UNKNOWN PROCEDURE THE FIRST DEVICE JAMMED. A SECOND DEVICE WAS PULLED AND THE SAME THING OCCURRED. UNKNOWN HOW THE CASE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1