BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_ULTRACISION HARMONIC FOCUS

    MDR report key: 22371556 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-04943
    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: EXPLORATION OF THE USE OF ULTRASOUND KNIVES IN RE-SURGERY FOR DIFFERENTIATED THYROID CANCER. AUTHOR: DING YONG, WU HAITAO, XIA CUNLIN, WANG JAILIANG. CITATION: BENGBU MEDICAL SCHOOL JOURNAL DECEMBER 2017 VOLUME 42, ISSUE 12 DOI:10. 13898/J.CNKI. ISSN. 1000-2200.2017. 12.015. THE AIM OF THIS STUDY IS TO EXPLORE THE EFFECTS OF THE APPLICATION OF THE ULTRASOUND KNIFE IN RE-SURGERY AFTER PARTIAL EXCISION OF DIFFERENTIATED THYROID CANCER. FIFTY-TWO (52) PATIENTS WITH DIFFERENTIATED THYROID CANCER WERE SELECTED, ALL OF WHICH WERE LOCAL RESECTION OF BENIGN TUMORS AT THE TIME OF THE PATIENT'S FIRST SURGERY. AFTER THE PROCEDURE, THE PATHOLOGY WAS CONFIRMED TO BE DIFFERENTIATED THYROID CANCER. ALL PATIENTS WERE DIVIDED INTO TWO GROUPS USING THE RANDOM NUMERICAL TABLE METHOD, WITH THE ULTRASOUND KNIFE SET (25 CASES) PERFORMING THE ENTIRE PROCEDURE USING THE ULTRASOUND KNIFE AND THE TRADITIONAL SET (27 CASES) PERFORMING THE PROCEDURE USING THE TRADITIONAL METHOD OF BINDING. BOTH GROUPS ARE OPERATED BY THE SAME SURGEON. ULTRASOUND BLADES USE FOCUS-TYPE BLADES AND ARE PURCHASED FROM JOHNSON & JOHNSON USA. REPORTED COMPLICATIONS INCLUDED BLEEDING (N=?), POST-OPERATIVE DRAINAGE (N=?) IN CONCLUSION THE USE OF ULTRASOUND KNIVES IN RE-SURGERY AFTER PARTIAL EXCISION OF PATIENTS WITH DIFFERENTIATED THYROID CANCER IS BETTER THAN THE METHOD OF CROSS-THREAD BINDING AND IS WORTH PROMOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261833 UNK_ULTRACISION HARMONIC FOCUS INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GENERATOR