BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*45 ENDOPATH**

    MDR report key: 2153737 · Received July 7, 2011

    Report

    Report Number
    3005075853-2011-02794
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 22, 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
    CH
    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 ECR45G CARTRIDGE RELOADS WERE RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND PARTIALLY FIRED. THE RETURNED CARTRIDGE RELOADS WERE TESTED FOR FUNCTIONALITY BY RESETTING AND LOADING THEM 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. EVENT COULD NOT BE CONFIRMED AS NO DEVICES WERE RETURNED FOR ANALYSIS. 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 AN UNKNOWN PROCEDURE, THE STAPLES WERE MALFORMED AFTER FIRING. THE SECOND ONE HAD THE SAME PROBLEM. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*45 ENDOPATH** STAPLES, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1