BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETHICON HARMONIC FOCUS

    MDR report key: 4934837 · Received July 3, 2015

    Report

    Report Number
    4934837
    Event Type
    Death
    Date Received
    July 3, 2015
    Date of Event
    June 16, 2015
    Report Date
    July 3, 2015
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A NEAR TOTAL THYROIDECTOMY WITH RECURRENT LARYNGEAL MONITORING. AT THE END OF THE PROCEDURE, HEMOSTASIS WAS ACHIEVED USING A COMBINATION OF SURGICEL AND ELECTROCAUTERY. THERE WERE NO SIGNS OF BLEEDING. PROCEDURE ENDED AROUND 0835. HIS INITIAL RECOVERY WAS GOING SMOOTHLY UNTIL APPROXIMATELY 0400 THE FOLLOWING MORNING WHEN HE RAPIDLY DEVELOPED A HEMATOMA IN THE NECK AND DIFFICULTY BREATHING. HE RETURNED TO THE OR WHERE BLEEDING WAS IDENTIFIED FROM THE RIGHT SUPERIOR THYROID ARTERY. IT APPEARED THAT ALL BLEEDING VESSELS WERE PREVIOUSLY LIGATED WITH THE HARMONIC FOCUS HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434012 ETHICON HARMONIC FOCUS INSTRUMENT, ULTRASONIC SURGICAL NLQ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death