BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2973672 · Received February 22, 2013

    Report

    Report Number
    3005075853-2013-00794
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    December 4, 2012
    Report Date
    February 1, 2013
    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
    UT, US
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED WITH THE BLADE BROKEN OFF AND NOT RETURNED. DURING FUNCTIONAL TESTING ON A GENERATOR THE DEVICE GAVE AN ERROR CODE 5. IN ADDITION, THE HAND CONTROL SWITCH ASSEMBLY WAS NOT FUNCTIONAL. HOWEVER, THE DEVICE DID ACTIVATE WHEN TESTED WITH THE FOOT SWITCH. THE DEVICE WAS DISASSEMBLED TO INSPECT INTERNAL COMPONENTS. DRIED BODY FLUIDS WERE FOUND AT THE HAND ACTIVATION DOMES. IT IS PROBABLE THAT THIS MAY HAVE AFFECTED THE FUNCTIONALITY OF THE HAND ACTIVATION BUTTONS.THE DEVICE WILL STOP ACTIVATING, AND DISPLAY AN INSTRUMENT ERROR ON THE GENERATOR WHEN THE BLADE BECOMES DAMAGED. THE LOCATION OF THE BREAK IS INSIDE THE TUBE PROXIMAL TO THE TISSUE PAD. THE ANALYSIS CONCLUDED THAT THE BLADE BROKE OFF 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 TIP BROKE OFF IN THE PATIENT. THE TIP WAS REMOVED AND INCLUDED IN THE RED BAG. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77669 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE