BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3970422 · Received July 31, 2014

    Report

    Report Number
    3005075853-2014-05363
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 20, 2014
    Report Date
    July 22, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. 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). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE WAS RETURNED WITH THE BLADE TIP BROKE OFF AND NOT RETURNED. DURING FUNCTIONAL TESTING ON GEN11 AN ALERT SCREEN WAS DISPLAYED. THE DEVICE WILL STOP ACTIVATING WHEN THE BLADE BECOMES DAMAGED. THE DEVICE WAS VISUALLY INSPECTED AND DAMAGE ON THE BROKEN BLADE WAS LOCATED INSIDE THE TUBE PROXIMAL TO THE TISSUE PAD. 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 AND CONTINUED USAGE CAN RESULT IN A BROKEN BLADE. THE ANALYSIS CONCLUDED THAT THE BLADE CRACKED DUE TO CONTACT WITH THE INNER TUBE. THIS DAMAGE WAS MOST LIKELY DUE TO EXCESSIVE SIDE FORCES APPLIED TO THE BLADE WHILE ACTIVATING RESULTING IN BLADE CONTACT WITH THE INNER TUBE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TITANIUM TIP BROKE DURING THE PRE-RUN TEST. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448123 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE