BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3955910 · Received July 24, 2014

    Report

    Report Number
    3005075853-2014-05201
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND NOT RETURNED. THE REMAINING BLADE PORTION WAS SCRATCHED. THIS BLADE TIP PORTION MAY HAVE BROKEN OFF OF THE DEVICE DURING TRANSPORT TO OUR ANALYSIS SITE. THE REPORTED COMPLAINT WAS FOR ACTIVATION BUTTON DID NOT WORK PROPERLY THE DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR. DURING FUNCTIONAL TESTING ON GEN11 AN ALERT SCREEN WAS DISPLAYED. A PROBABLE CAUSE OF 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. THE DEVICE WAS DISASSEMBLED TO EXAMINE THE CONDITION OF THE INTERNAL HAND ACTIVATION COMPONENTS AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE, DURING TESTING, THE ACTIVATION BUTTON DID NOT WORK PROPERLY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433820 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE