BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED STAPLER

    MDR report key: 2142514 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02648
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 2, 2011
    Report Date
    June 9, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THERE WAS A PACKAGING LOT OR BATCH NUMBER PROVIDED BY THE USER FACILITY. WITH THIS INFORMATION, THE MANUFACTURING RELATED RECORDS WERE REVIEWED AND WE WERE UNABLE TO CONFIRM THE COMPLAINT NOR DETERMINE A MANUFACTURING OR DESIGN RELATED CAUSE FOR THE REPORTED EVENT. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Additional Manufacturer Narrative · 1

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

    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 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 DURING A RECTOSIGMOIDECTOMY PROCEDURE, THE SURGEON REPORTED THAT THE STAPLER PRESENTED PROBLEMS. IT CUT BUT DIDN'T STAPLE. THERE WASN'T ANY DAMAGE TO THE PATIENT BECAUSE THE SURGEON REPLACED THIS STAPLER BY ANOTHER ONE WHEN HE NOTICED THE PROBLEM DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4UF2Y

    Patients

    Seq Age Sex Outcome Treatment
    1