BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON

    MDR report key: 2253296 · Received September 19, 2011

    Report

    Report Number
    3005075853-2011-03856
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    August 30, 2011
    Report Date
    August 30, 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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). INCOMPLETE/INTERRUPTED FIRING. THE ECR45M CARTRIDGE RELOAD WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND PARTIALLY FIRED. A PARTIAL FIRE CAN OCCUR IF THE FIRING SEQUENCE IS INTERRUPTED, THE DEVICE IS OPENED, THEN CLOSED AND FIRING IS RESUMED, CAUSING THE INSTRUMENT TO LOCK OUT. THE RETURNED CARTRIDGE RELOAD WAS TESTED FOR FUNCTIONALITY BY RESETTING AND LOADING IT INTO A TEST DEVICE. THE FUNCTIONAL TEST DEMONSTRATED THAT THE REMAINING STAPLES IN THE CARTRIDGE RELOAD FORMED PROPERLY AND THE INSTRUMENT ACHIEVED ITS COMPLETE 3-STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, NOT WELL FORMED B SHAPE STAPLES. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1