BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45

    MDR report key: 1902360 · Received November 18, 2010

    Report

    Report Number
    3005075853-2010-06580
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE EC45AL DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH A BLUE CARTRIDGE RELOAD PRESENT. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED 1/10. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE CARTRIDGE WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD AND LOCKING THE CARTRIDGE. THE RETURNED CARTRIDGE RELOAD WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION BY RESETTING AND RELOADING IT INTO THE DEVICE. THE DEVICE ACHIEVED ITS COMPLETE STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE DEVICE OPENED AND CLOSED AS INTENDED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP WOULD NOT CLOSE OR SOMETIMES THERE WAS A TEAR DROP SHAPED CLIP FIRE. NO FURTHER DETAILS ARE AVAILABLE AND THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ROUX-EN-Y, THE TECH LOADED THE DEVICE AND COULD NOT GET IT TO CLOSE. THE CARTRIDGE WAS SEATED PROPERLY. THEY THEN REMOVED THE CARTRIDGE AND TRIED TO CLOSE THE DEVICE AND IT MADE A LOUD CLICK AND THEN THEY COULD NOT GET IT BACK OPEN. AT THIS TIME THERE WAS NO RELOAD PRESENT IN THE DEVICE. THEY COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. G4TG3L

    Patients

    Seq Age Sex Outcome Treatment
    1