BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 1822954 · Received September 1, 2010

    Report

    Report Number
    3005075853-2010-05023
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 12, 2010
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PUSH ROD. 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 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. 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. 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 THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. THE DEVICE LOCKED UP AND WOULD NOT OPEN. THE DEVICE WAS NOT ON TISSUE AT THE TIME OF THE INCIDENT. THE JAWS ARE STILL CLOSED IN THE BAG. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO 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 G4RT3H

    Patients

    Seq Age Sex Outcome Treatment
    1 BLUE RELOAD