BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3802266 · Received May 9, 2014

    Report

    Report Number
    3005075853-2014-03146
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    April 14, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE EC60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE ECR60W 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 BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE COULD NOT BE OPENED AFTER INSERTING THROUGH A TROCAR. NO FURTHER INFORMATION IS AVAILABLE. NO PATIENT CONSEQUENCES REPORTED. PROCEDURE WAS COMPLETED WITH SAME LIKE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280312 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DT91

    Patients

    Seq Age Sex Outcome Treatment
    1