BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3013107 · Received March 20, 2013

    Report

    Report Number
    3005075853-2013-01319
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 13, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND NOT RETURNED. THE REMAINING BLADE PORTION WAS SCRATCHED. THIS BLADE TIP PORTION MAY HAVE BROKEN OFF OF THE DEVICE DURING TRANSPORT TO OUR ANALYSIS SITE. THE REPORTED COMPLAINT WAS FOR THE 'TIGHTEN ASSEMBLY' CODE SHOWED UP ON THE SCREEN. THE DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR. DURING FUNCTIONAL TESTING ON GEN11 AND THE RELAX PRESSURE ON BLADE AND THE INSTRUMENT ERROR SCREENS WAS DISPLAYED.. THE TIGHTEN ASSEMBLY SCREEN WAS NOT DISPLAYED AS THE BLADE TIP WAS BROKEN OFF. PROBABLE CAUSES OF BLADE DAMAGE, INCLUDING BREAKAGE, ARE EXTERNAL CONTACT DURING PRE-OP OR GENERAL USE, BLADE CONTACT WITH OTHER DEVICES, STAPLES OR CLIPS DURING THE PROCEDURE OR USING ANY MEANS OTHER THAN THE BLADE WRENCH TO ATTACH OR DETACH THE BLADE. ONCE MINOR BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY INCREASE DAMAGE SEVERITY AND RESULT IN YELLOW ALERT SCREENS, SUCH AS 'TIGHTEN ASSEMBLY' OR 'BLADE ERROR DETECTED' FOLLOWED BY A 'REPLACE INSTRUMENT' SCREEN LATER IN THE PROCEDURE, AND CONTINUED USAGE CAN RESULT IN A BROKEN BLADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE 'TIGHTEN ASSEMBLY' CODE SHOWED UP ON THE SCREEN. TROUBLE SHOOTING STEPS TAKEN, STILL NOT WORKING. CHANGED HAND PIECE, STILL NOT WORKING. A NEW DEVICE WAS OPENED AND THE CASE WAS COMPLETED WITHOUT FURTHER PROBLEMS.THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115929 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK J92N5G

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE