BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CUTTER STAPLER

    MDR report key: 3973284 · Received August 1, 2014

    Report

    Report Number
    3005075853-2014-05404
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE CS40G DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH NO RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH AN ENGINEERING SAMPLE RELOAD AND THE DEVICE FIRED, FORMING ALL STAPLES AND CUTTING AS INTENDED. THE CUT LINE WAS COMPLETE, THE STAPLE LINE WAS COMPLETE, AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE DEVICE LOCKOUT AND THE RELOAD LOCKOUT WERE FUNCTIONAL. EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RECEIVED FOR ANALYSIS. A BATCH RECORD REVIEW WAS PERFORMED AND THE BATCH HAD NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY PROCEDURE, THE STAPLER WAS CLAMPED ON THE TISSUE OF THE SIGMOID RECTUM AND FIRED. ONCE RELEASED, THERE WAS NO TRANSECTION LINE AND THE STAPLES HAD COME OUT AND FORMED; HOWEVER; HAD NOT FORMED ON THE TISSUE BUT RATHER JUST OUTSIDE THE CARTRIDGE. THIS HAPPENED ON THE FIRST FIRING. THE SURGEON THEN HAD TO RESORT TO USING ANOTHER STAPLER. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450355 CONTOUR CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EM28

    Patients

    Seq Age Sex Outcome Treatment
    1