BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3232495 · Received July 18, 2013

    Report

    Report Number
    3005075853-2013-03604
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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). THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND NOT RETURNED. THE REMAINING BLADE PORTION WAS SCRATCHED. THE DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR USING THE FOOTSWITCH BECAUSE THE HAND CONTROL BUTTONS WERE NONFUNCTIONAL. DURING FUNCTIONAL TESTING ON GEN11 AN INSTRUMENT ERROR WAS DISPLAYED. BECAUSE THE HAND CONTROL BUTTONS WERE NON-FUNCTIONAL THE DEVICE WAS DISASSEMBLED TO INSPECT INTERNAL COMPONENTS. CORROSION WAS FOUND AT THE HAND ACTIVATION DOMES. THE CORROSION IN THE DOMES IS POSSIBLY CAUSED WHEN THE DEVICE WAS SOAKED FOR RE-USE; THE INTRODUCTION OF SALINE OR BLOOD GETTING UP INTO THE DEVICE DURING THE PROCEDURE, OR THE DEVICE BEING SOAKED FOR CLEANING BEFORE SHIPMENT FOR ANALYSIS. IT IS PROBABLE THAT THIS MAY HAVE AFFECTED THE FUNCTIONALITY OF THE HAND CONTROL ACTIVATION BUTTONS. A PROBABLE CAUSE OF THE DEVICE STOP ACTIVATING AND DISPLAY AN INSTRUMENT ERROR 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 YELLOW ALERT SCREENS, SUCH AS ¿TIGHTEN ASSEMBLY¿ OR ¿BLADE ERROR DETECTED¿ FOLLOWED BY A ¿REPLACE INSTRUMENT¿ SCREEN LATER IN THE PROCEDURE, AND CONTINUED USAGE CAN RESULT IN A BROKEN BLADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE, THE BLADE OF THE DEVICE BROKE DURING THE USAGE, OUTSIDE OF THE PATIENT'S BODY. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334875 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK J92R84

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE