BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER

    MDR report key: 4202547 · Received October 27, 2014

    Report

    Report Number
    3005075853-2014-07372
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Report Date
    September 29, 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
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: DID THE DEVICE CUT? IF THE DEVICE CUT WAS THE CUT LINE COMPLETE? WHAT TYPE OF PROCEDURE WAS THE DEVICE USED IN? HOW WAS THE CASE COMPLETED? THE ANALYSIS RESULTS SHOWED THAT THE CS40B 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. 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 DID NOT DEPLOY STAPLES. UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684579 CONTOUR CURVED CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1