BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_ULTRACISION HARMONIC FOCUS

    MDR report key: 9383466 · Received November 27, 2019

    Report

    Report Number
    3005075853-2019-23792
    Event Type
    Injury
    Date Received
    November 27, 2019
    Report Date
    October 31, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2009. MEDICAL DEVICE: BATCH # UNK. (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: IMPLEMENTING THE GENERAL USE OF DISSECTION DEVICES IN THYROID SURGERY FROM PROSPECTIVE RANDOMIZED TRIAL TO DAILY USE. AUTHOR: PETER E. GORETZKI, MD; KATHARINA SCHWARZ, MD; BERHARD J. LAMMERS, MD CITATION: SURGICAL TECHNOLOGY INTERNATIONAL XVIII P86-92. THIS PROSPECTIVE STUDY DISCUSSED ABOUT IMPLEMENTING THE GENERAL USE OF DISSECTION DEVICE IN THYROID SURGERY. BETWEEN 01JAN2003 AND 31DEC2007, SURGEONS WERE FREE TO DECIDE WHETHER THEY WANTED TO USE ANY DISSECTION DEVICE IN THYROID SURGERY. DURING THIS TIME PERIOD, 2591 PATIENTS WERE OPERATED ON FOR DIFFERENT THYROID DISEASES, AND IN 1654 PATIENTS A DEVICE WAS USED. A TOTAL OF 96 PATIENTS WERE OPERATED WITH AN ULTRASONICALLY POWERED (FOCUS; ETHICON) GROUP 1 AND 100 PATIENTS OPERATED WITH HIGH-FREQUENCY ELECTROTHERMAL POWERED DEVICE AS GROUP 2. REPORTED COMPLICATIONS IN GROUP 1 INCLUDED BLEEDING (N=2); HEMATOMA (N=1); EARLY RECURRENT LARYNGEAL NERVE PARALYSIS (RLNP) (N=3); AND SEROMA (N=1). IN CONCLUSION, THE RESULTS PROVED SURGERY WITH SEALING DEVICES TO BE SAFE AND MORE COST EFFECTIVE THAN THE CONVENTIONAL THYROID SURGERY UNDER NON-STUDY CONDITIONS IN A HIGH THYROID VOLUME CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180269 UNK_ULTRACISION HARMONIC FOCUS INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1