BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 2982160 · Received February 28, 2013

    Report

    Report Number
    3005075853-2013-00882
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 12, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K063192
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ADDED ADDITIONAL INFORMATION DEVICE A WAS RETURNED IN GOOD PHYSICAL CONDITION BUT THE DEVICE'S SHELF LIFE HAD EXPIRED. THE EXPIRATION DATE WAS NOVEMBER, 12, 2012. THE TISSUE PAD WAS INSPECTED AND IT WAS FOUND CONFORMING. THE DEVICE WAS TESTED WITH A GENERATOR AND WAS FUNCTIONAL, ACTIVATING WHEN EACH OF THE MAX AND MIN ACTIVATION BUTTONS WERE DEPRESSED. THE DEVICE WAS DISASSEMBLED AND NO ANOMALIES WERE FOUND. THE BUTTON ASSEMBLY WAS DISASSEMBLED AND INSPECTED FOR EVIDENCE ASSOCIATED WITH ACTIVATION ISSUES. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE INCIDENTS REPORTED. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. DEVICE B WAS RECEIVED IN GOOD PHYSICAL CONDITION. THE TISSUE PAD WAS INSPECTED AND IT WAS FOUND CONFORMING. THE DEVICE WAS TESTED ON THE GENERATOR AND IT WAS FOUND THAT THE MIN HAND CONTROL SWITCH ASSEMBLY BUTTON WAS NOT FUNCTIONAL. HOWEVER, IT WORKED PROPERLY WITH FOOT SWITCH ASSEMBLY. THE INSTRUMENT WAS DISASSEMBLED AND DAMAGED WAS FOUND TO THE FLEXIBLE CIRCUIT, IN THE FORM OF CORROSION UNDER THE SWITCH DOME ASSEMBLY OF THE MIN BUTTON. THIS CAUSED THE NON-ACTIVATION OF THE MIN BUTTON. AS THE MANUFACTURING PROCESS WOULD NOT HAVE CAUSED CORROSION, IT IS PROBABLE THAT THE DEVICE WAS PRE-CLEANED BEFORE BEING SENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE, THERE WAS A PROBLEM WITH TWO DEVICES. THE FIRST DEVICE DEFAULTED ON THE MIN SETTING, BUT SOMEHOW THE MAX SETTING WAS WORKING. UNFORTUNATELY, THEY ONLY USE THE MIN SETTING FOR ALL OUR CASES. THE HAND PIECE WAS CHANGED AND THE SAME THING HAPPENS. A NEW DEVICE WAS OPENED AND WORKED. THE SECOND DEVICE WAS OPERATING EFFICIENTLY WHEN THE INACTIVE TISSUE PAD WAS SLIDING DOWN AND DISLODGED. THEY REPLACED ANOTHER SHEAR AND FINISHED THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86455 HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK J4CG0U

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE