BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 2763858 · Received September 28, 2012

    Report

    Report Number
    3005075853-2012-04423
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    August 24, 2012
    Report Date
    September 5, 2012
    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
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ADDED ADDITIONAL INFORMATION. THE ANALYSIS RESULTS CONFIRMED THAT THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND NOT PRESENT. THE REMAINING BLADE PORTION WAS NOT RETURNED. THE DEVICE WAS ACTIVATED WITH THE GENERATOR AND AN ERROR CODE 5 WAS DISPLAYED. 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 AN ERROR CODE 5 OR BLADE 'LOCKOUT' LATER IN THE PROCEDURE, AND CONTINUED USAGE CAN RESULT IN A BROKEN BLADE.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. 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, THE SURGEON WAS USING THE FOCUS. HE ACTIVATED THE DEVICE FOR SEVERAL TIMES AND IT WORKED JUST FINE. SUDDENLY THE GEN04 STARTED TO MAKE A VERY LOUD AND SOLID NOISE AND THE DEVICE DIDN´T CUT OR COAGULATE. THE BIOMED GUY TURNED OFF THE GENERATOR, UNPLUGGED THE HANDPIECE AND RECONNECTED THE FOCUS DEVICE. IT STARTED TO WORK AGAIN AND THEN IT BEGAN TO MAKE THE SAME NOISE AND STOP CUTTING AND COAGULATING. THIS HAPPENED ONE MORE TIME AND THEN THE ACTIVATED TIP BROKE AND FELL INTO THE PATIENT. THE SURGEON TOOK OUT THE TIP AND HAD TO OPEN A NEW FOCUS DEVICE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK J4A248

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE