BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER

    MDR report key: 3852014 · Received June 5, 2014

    Report

    Report Number
    3005075853-2014-03813
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE CS40G DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH ONE RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY LOADED WITH STAPLES, WITH THE WASHER UNCUT AND WITH THE DRIVERS AND KNIFE RECESSED BELOW THE CARTRIDGE DECK. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED RELOAD AND IT 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 CARTRIDGE LOCKOUT WERE FUNCTIONAL, AND THE DEVICE FIRED WITHOUT ANY DIFFICULTIES. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WERE MALFORMED STAPLES DEPLOYED AND THE LEGS WERE IRREGULAR. CHANGED TO HAND SEWING TO COMPLETE THE PROCEDURE. NO REPORTED ADVERSE EVENT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328634 CONTOUR CURVED CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DC3F

    Patients

    Seq Age Sex Outcome Treatment
    1