BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3961939 · Received July 28, 2014

    Report

    Report Number
    3005075853-2014-05281
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 17, 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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND NOT RETURNED. THE REMAINING BLADE PORTION WAS SCRATCHED, EVIDENCE OF CONTACT WITH METAL IN OR OUT OF THE OPERATIVE FIELD. IN ADDITION, THE CLAMP ARM WAS FOUND TO BE DETACHED FROM THE INNER TUBE, BUT FIRMLY FIXED TO THE OUTER TUBE AT THE CLAMP ARM WELD. THE DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR. DURING FUNCTIONAL TESTING ON GEN11 AN ALERT SCREEN WAS DISPLAYED. A PROBABLE CAUSE OF THE DEVICE STOP ACTIVATING AND DISPLAY AN ALERT SCREEN IS BLADE DAMAGE. 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. POSSIBLE CAUSES OF THE CLAMP ARM DETACHMENT ARE NOT CLOSING THE TRIGGER WHEN SLIDING THE TORQUE WRENCH ON AND OFF; NOT CLOSING THE TRIGGER WHEN INTRODUCING OR REMOVING THROUGH THE TROCAR; OR POSSIBLE ENTANGLEMENT IN FIBROUS TISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, BLADE BROKE DURING FIRST USE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438134 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK K91E22

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE