BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD RELOAD

    MDR report key: 2173045 · Received July 23, 2011

    Report

    Report Number
    3005075853-2011-02950
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE PIECE SLED. THE ECR60D RELOAD WAS RECEIVED FOR ANALYSIS WITH THE ONE-PIECE SLED DAMAGED AND FULLY LOADED WITH STAPLES. IMPROPER LOADING OF THE RELOAD MAY DAMAGE THE SLED. IF THE RELOAD IS NOT FULLY SEATED WHEN THE DEVICE IS CLOSED, THE SLED WILL BREAK. WHEN INSERTING THE RELOAD, SLIDE IT AGAINST THE BOTTOM OF THE RELOAD JAW UNTIL THE RELOAD ALIGNMENT TAB STOPS IN THE RELOAD ALIGNMENT SLOT. SNAP THE RELOAD SECURELY IN PLACE. THE INSTRUMENT IS NOW LOADED AND READY FOR USE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR THE COMPLETE GUIDE TO LOADING AND RELOADING THE INSTRUMENT. DUE TO THE CONDITION OF THE RELOAD, NO FUNCTIONAL TEST COULD BE PERFORMED. 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 LAP GASTRIC BYPASS REVISION PROCEDURE, THE GREEN RELOAD WAS OPENED AND IMMEDIATELY AND THE SCRUB NOTICED THAT THERE WAS A PROBLEM WITH THE RELOADS AS SOME OF THE STAPLE DRIVERS WERE DISLODGED IN THE CARTRIDGE. THE NURSE ALSO OPENED THE GOLD RELOAD AND NOTICED A SIMILAR PROBLEM. BOTH RELOADS WERE NOT USED AND REPLACEMENTS WERE OPENED. SURGERY WAS PROLONGED FIVE MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLD RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1