BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_ULTRACISION HARMONIC FOCUS

    MDR report key: 22371698 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-04944
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    January 1, 2017
    Report Date
    July 1, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 7/1/2025 B3: PUBLICATION YEAR OF 2017. D4: BATCH # UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    TITLE: APPLICATION OF HARMONIC FOCUS SCALPEL IN LOW-COLLAR SMALL-INCISION RADICAL THYROIDECTOMY. AUTHOR: WANG XIAOLAN ZHANG DIANLONG, WU BIN LIU TAO WU XIAOFEI. CITATION: CHINESE MATERNAL AND CHILD HEALTH STUDY 2017 VOL. 28 1673-5293 (2017) 07-0027-01. THE AIM OF THIS STUDY IS TO EXPLORE THE APPLICATION AND SKILLS OF F0CUS ULTRASONIC KNIFE IN RADICAL THYROIDECTOMY WITH LOW COLLAR SMALL INCISION. 220 PATIENTS WITH THYROID CANCER SCHEDULED FOR RADICAL SURGERY IN THE DEPARTMENT OF BREAST AND THYROID SURGERY OF OUR HOSPITAL WERE RANDOMLY DIVIDED INTO F0CUS ULTRA-KNIFE GROUP (N = 112) AND CONVENTIONAL SURGERY GROUP (N = 108). HARMONIC FOCUS ULTRASOUND KNIFE WAS PRODUCED BY JOHNSON & JOHNSON, REPORTED COMPLICATIONS INCLUDED LYMPHATIC FISTULA (N=1), TEMPRARY VOICE CHANGE (N=8). IN CONCLUSION COMPARED WITH CONVENTIONAL GROUP, THE APPLICATION OF HARMONIC FOCUS IN THE FUNCTIONAL NECK DISSECTION HAS SIGNIFICANT ADVANTAGES OF LESSEN THE LENGTH OF INCISION, LESS OPERATION TIME, LESS INTRAOPERATIVE BLOOD LOSS AND EASY CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193714 UNK_ULTRACISION HARMONIC FOCUS INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GENERATOR