BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3910869 · Received July 2, 2014

    Report

    Report Number
    3005075853-2014-04616
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 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
    CH
    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). ADDITIONAL INFORMATION: DEVICE WAS REPROCESSED. THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND NOT RETURNED. THE REMAINING BLADE PORTION WAS SCRATCHED, EVIDENCE OF CONTACT WITH METAL IN OR OUT OF THE OPERATIVE FIELD. THE DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR. DURING FUNCTIONAL TESTING ON GEN04 AN ERROR CODE 5 WAS DISPLAYED. A PROBABLE CAUSE OF THE DEVICE STOP ACTIVATING AND DISPLAY AN ERROR CODE 5 IS BLADE DAMAGE. IN ADDITION, THE MIN HAND CONTROL BUTTON WAS NOT FUNCTIONAL. THE DEVICE WAS DISASSEMBLED TO INSPECT INTERNAL COMPONENTS. CORROSION WAS FOUND AT THE MIN HAND ACTIVATION DOMES. DUE TO THE CORROSION MOISTURE DISCOVERED ON THE INSTRUMENT WHICH IS EVIDENCE OF POSSIBLE REUSE/REPROCESSING, WE ARE UNABLE TO DETERMINE HOW THIS CONDITION IMPACTED THE PERFORMANCE OF THE DEVICE AND THEREFORE CANNOT CONCLUDE ROOT CAUSE. OUR MANUFACTURING, STERILIZATION, PACKAGING, AND SHIPMENT PROCESSES DO NOT INTRODUCE CORROSION TO THE DEVICE. DEVICE WAS REPROCESSED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS A SOLID TONE WITH ERROR CODE '5'. REINSTALLED THE TITANIUM TIP BROKE DURING THE PRE-RUN TEST. THE BROKEN PIECE DIDN'T FALL INTO THE PATIENT'S BODY. CHANGED 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
    388252 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE