BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3915376 · Received July 7, 2014

    Report

    Report Number
    3005075853-2014-04668
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 28, 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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. 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. THE DEVICE WAS ASSEMBLED AND DISASSEMBLED TO A HANDPIECE WITHOUT ANY DIFFICULTY AND ROTATES FREELY. 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. 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 LOBECTOMY PROCEDURE THE SURGEON USED THE HARMONIC. THE INSTRUMENT AND HANDPIECE DIDN'T CONNECT WELL. THE SCRUB NURSE RECONNECTED INSTRUMENT AND THE HANDPIECE. THE INSTRUMENT'S TIP WAS BROKEN AT THE TESTING PROCESS. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394251 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNKI

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE