BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG 45 ENDOCUTTER

    MDR report key: 2182928 · Received July 28, 2011

    Report

    Report Number
    3005075853-2011-03067
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 ANALYSIS RESULTS FOUND THAT THE ETS45 DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROBOTIC CYSTECTOMY PROCEDURE, ON THE FIRST FIRING WITH A WHITE CARTRIDGE THE DEVICE WAS DIFFICULT TO CLOSE AND THE STAPLES DID NOT FULLY FORM. ON THE SECOND FIRING THE SURGEON WAITED FIFTEEN SECOND BEFORE FIRING AND THE DEVICE FIRED BETTER BUT THERE WAS SOME BLEEDING. FOR THE THIRD FIRING THE SURGEON WAITED FIFTEEN SECONDS AND THEN FIRED. AGAIN THERE WAS SOME BLEEDING. THE BLEEDING WAS CONTROLLED BY SUTURE. THE DEVICE WAS FIRED A FOURTH TIME AND THE STAPLES WERE TWISTED AND MANGLED. A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG 45 ENDOCUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 TR45W