BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3930244 · Received July 11, 2014

    Report

    Report Number
    3005075853-2014-04888
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 6, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. DEVICE EVALUATION - 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 RECEIVED WITH THE BLADE DISCOLORED (BLUE) DUE TO HEAT GENERATED FROM CONTACT BETWEEN THE BLADE AND TISSUE PAD. 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. THE BLADE WAS FOUND TO BE BROKEN AT THE DISCOLORED (BLUE). PROBABLE CAUSE OF BLADE DISCOLORATION IS APPLYING PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. 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 LAP HYSTERECTOMY, ¿RELAX PRESSURE ON BLADE¿ WAS DISPLAYED WHEN THE DEVICE WAS USED FOR A LIGAMENT. THE BLADE WAS BROKEN OFF INSIDE THE PATIENT WHEN THE DEVICE CLAMPED THE LIGAMENT AGAIN AND WAS REACTIVATED. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT WITH A FORCEPS VIA A TROCAR. THERE WAS NO BLEEDING DUE TO THE EVENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406430 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA L90L41

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE