BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3790161 · Received May 5, 2014

    Report

    Report Number
    3005075853-2014-03031
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 5, 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

    RESULTS: INTERFERENCE BETWEEN YOKE AND SHROUD. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION WITH THE TORQUE WRENCH STUCK ON THE SHAFT AT THE ROTATION KNOB AREA. THE DEVICE WAS TESTED WITH A GENERATOR AND WAS FUNCTIONAL; HOWEVER THE CLAMP WAS DIFFICULT TO OPEN. THE TORQUE WRENCH WAS REMOVED AND THE CLAMP COULD BE CLOSED AND OPENED AS INTENDED. THE TORQUE WRENCH WAS FOUND DAMAGED AT THE INTERFACE AREA CAUSING THE STUCK CONDITION AND THE CLAMP FAILURE. POSSIBLE CAUSE IS FORCING THE TORQUE WRENCH INTO THE SHAFT. THE DEVICE WAS DISASSEMBLED TO INSPECT INTERNAL COMPONENTS. CORROSION WAS FOUND AT THE HAND ACTIVATION FLEX CIRCUIT. THE CORROSION IS POSSIBLY CAUSED WHEN THE DEVICE WAS SOAKED FOR RE-USE OR THE DEVICE BEING SOAKED FOR CLEANING BEFORE SHIPMENT FOR ANALYSIS. THE REPORTED FAILURE WAS CONFIRMED BUT THE ROOT CAUSE CANNOT BE IDENTIFIED BECAUSE IT IS UNKNOWN WHEN THE CORROSION OCCURRED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLAMP COULD NOT OPENED AS USUAL. CHANGED TO ANOTHER PRODUCT TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266675 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE