BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 2170446 · Received July 21, 2011

    Report

    Report Number
    3005075853-2011-02914
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 28, 2011
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETAINING PIN NOT_CONNECTED. THE ANALYSIS RESULTS SHOWED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY LOADED WITH STAPLES, WITH THE WASHER UNCUT, WITH THE DRIVERS AND WITH THE KNIFE RECESS BELOW THE RELOAD DECK. THE RELOAD WAS NOT PROPERLY LOADED IN THE DEVICE, AS THE RETAINING PIN WAS NOT CONNECTED TO THE COUPLER AND PUSHROD. THESE FACTS INDICATE THAT THE RELOAD WAS REMOVED AND REINSERTED INCORRECTLY AND/OR INCOMPLETELY AFTER THE RETAINER WAS REMOVED. THE RETURNED RELOAD WAS PULLED OUT OF THE DEVICE AND PLACED BACK ON; THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES. 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 RELOAD LOCKOUT WERE FUNCTIONAL. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES. IT SHOULD BE NOTED THAT IF THE RELOAD IS REMOVED FROM THE DEVICE, WHETHER THE RELOAD IS SPENT OR NOT, AND IF THE STAPLE RETAINER HAS ALREADY BEEN REMOVED FROM THE RELOAD, THE RELOAD CANNOT BE RELOADED INTO THE DEVICE. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR THE COMPLETE GUIDE TO LOADING AND RELOADING THE INSTRUMENT. EVENT COULD NOT BE CONFIRMED AS THE RETAINING PIN WORKED AS INTENDED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN LOW ANTERIOR RESECTION PROCEDURE, THE DEVICE WAS FIRED ON THE RECTUM AT THE FIRST FIRING. THE STAPLES OF THE ANUS SIDE (PATIENT'S SIDE) WERE NOT DEPLOYED AND THE TARGET TISSUE WAS NOT STAPLED. THE OTHER SIDE WAS STAPLED PROPERLY. REINFORCEMENT MATERIAL WAS NOT USED. ANOTHER COMPETITIVE DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA H43F8Z

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE