BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 COMPACT

    MDR report key: 2140710 · Received June 27, 2011

    Report

    Report Number
    3005075853-2011-02598
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 2, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE SC60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE ECR60D CARTRIDGE RELOAD LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED. 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. EVENT COULD NOT BE CONFIRMED AS THE DEVICE WAS RECEIVED IN THE OPENED POSITION AND THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPY-ASSISTED DISTAL GASTRECTOMY PROCEDURE, THE JAW COULD NOT BE OPENED IN CLAMPING THE GASTRIC BODY AFTER THE SECOND FIRING. ALTHOUGH THE MANUAL KNIFE REVERSE SWITCH WAS USED AND THE STROKE COUNT INDICATOR SHOWED "0", THE JAW COULD NOT BE OPENED. EVENTUALLY, THE PROCEDURE WAS COMPLETED BY USING A COMPETITOR'S TO CUT THE PATIENT'S SIDE AND THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. WHEN THE SALES REP TRIED TO OPEN THE JAW AFTER THE OPERATION, THE JAW WAS OPENED AS USUAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60D