BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 COMPACT

    MDR report key: 4140876 · Received October 3, 2014

    Report

    Report Number
    3005075853-2014-06826
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    August 5, 2014
    Report Date
    September 2, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE CONTACT. THE ANALYSIS FOUND THAT ONE SC60A DEVICE WAS RETURNED WITH THE KNIFE ADVANCED INTO THE LOCKOUT REGION AND WITH ONE ECR60D CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITION. 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 IT 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. PLEASE NOTE THAT THE DEVICE IS DESIGNED WITH A LOCKOUT SYSTEM TO AVOID FIRE A SPENT CARTRIDGE. THE DEVICE RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THORACOTOMY PROCEDURE WHEN THE DEVICE COULD NOT BE FIRED IT KEPT LOCKING OUT. THE RELOAD WAS REMOVED AND REPLACED WITH ANOTHER GOLD RELOAD AND THE SAME THING HAPPENED AGAIN. THIS RESULTED IN HAVING TO OPEN A NEW DEVICE WHICH WORKED OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619723 ECHELON*FLEX60 COMPACT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1