BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 4180427 · Received October 17, 2014

    Report

    Report Number
    3005075853-2014-07170
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 3, 2014
    Report Date
    October 3, 2014
    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
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND IT WAS RETURNED WITH THE DEVICE. THE REMAINING BLADE PORTION WAS SCRATCHED, EVIDENCE OF CONTACT WITH METAL IN OR OUT OF THE OPERATIVE FIELD. UPON FUNCTIONAL TESTING IT WAS NOTED THAT THE HAND ACTIVATION CONTACTS WERE DAMAGED. THEREFORE, FUNCTIONAL TESTING COULD NOT BE PERFORMED, AS IT DID NOT ENGAGE WITH THE HAND PIECE. IT WAS DIFFICULT TO ROTATE THE SHAFT WHEN THE INSTRUMENT WAS ATTACHED TO THE HAND PIECE. IT IS POSSIBLE THAT THE DAMAGE TO THE HAND ACTIVATION CONTACTS DID NOT ALLOW THE DEVICE TO BE TORQUE PROPERLY. THIS COULD HAVE RESULTED IN AN ALERT SCREEN OR ACTIVATION ISSUES. TO AVOID DAMAGING THE CONTACTS, IT IS RECOMMENDED TO ASSEMBLE THE DEVICE VERTICALLY. 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 ALERT SCREENS, SUCH AS ¿TIGHTEN ASSEMBLY¿, ¿BLADE ERROR DETECTED¿ OR "RELAXED PRESSURE ON BLADE" FOLLOWED BY A ¿REPLACE INSTRUMENT¿ SCREEN LATER IN THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HYSTERECTOMY PROCEDURE, THE HARMONIC ACE SHEARS WHEN BEING USED TO COAGULATE AND CUT TISSUE PRESENTS A BREAK IN THE BLADE. THE FRAGMENT THAT WAS LEFT IN THE CAVITY WAS RESCUED. THE SURGERY ENDED WITHOUT A PROBLEM. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662820 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE