BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2220390 · Received August 23, 2011

    Report

    Report Number
    3005075853-2011-03457
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 23, 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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE PIECE SLED. THE ECR60B 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BARIATRIC PROCEDURE, THE STAPLES WERE NOT VISIBLE. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION: BASED ON THE INFORMATION FROM OPERATION THEATRE THE DEVICE WAS NOT FIRED BECAUSE THE FIRING TRIGGER WAS NOT ADVANCING DOCTOR NOTICED SOME PROBLEM IN THE CARTRIDGE AND REPLACED WITH THE NEW ONE. THE O.T STAFF IS NOT AWARE ABOUT THE MISSING STAPLERS AND GUN USED FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1