BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 3962235 · Received July 28, 2014

    Report

    Report Number
    3005075853-2014-05285
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 17, 2014
    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
    IN
    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. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: DEVICE WAS REPROCESSED THE DEVICE WAS RECEIVED WITH THE SHROUDS SLIGHTLY SEPARATED, THE KNIFE WAS OUT OF PLACE AND LOOSE. DUE TO THE RETURNED CONDITION OF THE DEVICE NO FUNCTIONAL TESTING COULD BE PERFORMED AS THE INSTRUMENT COULD NOT BE ATTACHED TO A TEST HAND PIECE. UPON VISUAL INSPECTION UNDER MAGNIFICATION IT WAS NOTED THAT THE BLADE HAD HORIZONTAL SCRATCHES TYPICAL OF METAL SCRUBBING. DUE TO THE BLADE DAMAGE 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 BLADE DAMAGE OF THIS TYPE TO THE DEVICE. THE DEVICE HAS BEEN REPROCESSED

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT DURING A THYROIDECTOMY PROCEDURE, THERE WAS BLADE BREAKAGE DURING FIRST USE. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439468 HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE