BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LINEAR CUTTER

    MDR report key: 3840903 · Received May 30, 2014

    Report

    Report Number
    3005075853-2014-03674
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 12, 2014
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IF THE DEVICE IS RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT ONE EC60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE ECR60B CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITION. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED 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. IT SHOULD BE NOTED THAT IN ORDER TO OPEN A DEVICE THAT HAS BEEN PARTIALLY FIRED OR FULLY FIRED A REVERSE STROKE NEEDS TO BE PERFORMED TRIGGER TO TRIGGER TO HANDLE IN ORDER TO RETURN THE KNIFE TO THE HOME POSITION (INDICATOR IN THE "0" POSITION) AND PRESS THE ANVIL RELEASE BUTTON TO OPEN. EVENT COULD NOT BE CONFIRMED AS THE DEVICE CLOSED AND OPENED WITHOUT ANY DIFFICULTIES NOTED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC-ASSISTED DISTAL GASTRECTOMY (LADG), THE JAWS DID NOT OPEN AFTER THE FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318140 ECHELON*FLEX60 LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E239

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60B(LOT#:L4E67E)X1