BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON ENDO LINEAR CUTTERS

    MDR report key: 5211354 · Received November 9, 2015

    Report

    Report Number
    3005075853-2015-07168
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 15, 2015
    Report Date
    October 16, 2015
    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
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # M5516V. MANUFACTURE DATE: 8/25/2105. EXPIRATION DATE: 07/25/2020. THE ANALYSIS FOUND THAT ONE EC60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE ECR60G CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITION. IN ADDITION THE KNIFE WAS NOTED TO BE PARTIALLY ADVANCED INTO THE LOCKOUT REGION, THUS THE DEVICE WOULD NOT OPEN. THE KNIFE WAS RETURNED TO ITS HOME POSITION AND 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 MANUAL SWITCH WORKED AS INTENDED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THORACOTOMY PROCEDURE, IT IS ALLEGED THAT ON THE THIRD FIRING THE DEVICE LOCKED ON THE TISSUE AND COULD NOT BE OPENED. ALL THREE FIRINGS WERE WITH GREEN RELOADS. THE CARTRIDGE WAS LOADED CORRECTLY IN THE DEVICE AND IS STILL IN PLACE. THE SURGEON TRIED TO USE THE KNIFE REVERSE SWITCH BUT THIS DID NOT WORK. THE CONSULTANT CUT EITHER SIDE OF THE DEVICE WITH A KNIFE AND THEN OPENED A NEW DEVICE AND FIRED THE GUN WITHOUT ANY ISSUE THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740073 ECHELON ENDO LINEAR CUTTERS STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA M92K4J

    Patients

    Seq Age Sex Outcome Treatment
    1