BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3790243 · Received May 5, 2014

    Report

    Report Number
    3005075853-2014-03033
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    February 28, 2014
    Report Date
    March 7, 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). PIN HOLE THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION. THE DEVICE WAS FUNCTIONALLY TESTED ON THE GENERATOR AND THE MIN HAND ACTIVATION BUTTON WAS NOT FUNCTIONAL; WHEN TESTED WITH THE FOOTSWITCH AN ERROR CODE 5 SCREEN WAS DISPLAYED. THE DEVICE WAS DISASSEMBLED AND IT WAS FOUND THAT THE BLADE WAS CRACKED AT THE PIN HOLE UNDER THE SHROUD OF THE DEVICE; IN ADDITION, CORROSION WAS FOUND AT THE HAND ACTIVATION DOMES. IF THE HARMONIC SYSTEM SENSES AN INSTRUMENT FAULT DURING USE, AN AUDIBLE ALARM (TONE WITH LONG PULSES) WILL SOUND AND A VISUAL ALARM INDICATOR WILL APPEAR ON THE CONTROL PANEL. THE GENERATOR SYSTEM WILL REVERT TO STANDBY MODE, WHEN THE AUDIBLE ALARM (SOLID TONE) AND VISUAL ALARM INDICATOR APPEAR. ONCE MINOR BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY INCREASE DAMAGE SEVERITY AND RESULT IN AN ERROR CODE. THE CORROSION IN THE DOMES IS POSSIBLY CAUSED WHEN THE DEVICE WAS SOAKED FOR RE-USE OR THE DEVICE BEING SOAKED FOR CLEANING BEFORE SHIPMENT FOR ANALYSIS. THE ROOT CAUSE CANNOT BE IDENTIFIED BECAUSE IT IS UNKNOWN WHEN THE CORROSION OCCURRED. THE CORROSION WOULD HAVE INHIBITED ELECTRICAL CONTACT BETWEEN THE DOME AND THE CIRCUIT. OUR MANUFACTURING, STERILIZATION, PACKAGING AND SHIPMENT PROCESSES DO NOT INTRODUCE CORROSION TO THE DEVICE. IT IS PROBABLE THAT THIS MAY HAVE AFFECTED THE FUNCTIONALITY OF THE HAND ACTIVATION BUTTONS. WHEN THE BLADE IS DAMAGED AND PRIOR TO IT CRACKING, IT IS POSSIBLE TO FAIL PRE-RUN TEST, RESULTING IN AN ERROR CODE SCREEN. THIS WAS SEEN DURING OUR TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS A SOLID TONE WITH ERROR CODE '5' AND THE SCALPEL COULD NOT PASS THE PRE-RUN TEST AGAIN. CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266345 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE