BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_ULTRACISION HARMONIC FOCUS

    MDR report key: 22375631 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-05027
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    April 1, 2013
    Report Date
    July 1, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/1/2025. B3: PUBLICATION YEAR OF 2013. D4: BATCH # UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. 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: THE EFFICACY OF THE HARMONIC SCALPEL IN NECK DISSECTION: A PROSPECTIVE RANDOMIZED STUDY. AUTHOR/S: YOO SEOB SHIN, MD; YOON WOO KOH, MD, PHD; SE-HEON KIM, MD, PHD; EUN CHANG CHOI, MD, PHD. CITATION: LARYNGOSCOPE, 123:904¿909, 2013; DOI: 10.1002/LARY.23704. THIS PROSPECTIVE STUDY AIMED TO INVESTIGATE THE SAFETY AND EFFICACY OF THE HARMONIC SCALPEL (HS) IN NECK DISSECTION (ND), WHILE USING CONVENTIONAL HAND-TIED LIGATION TO A MINIMUM. BETWEEN JANUARY 2010 AND DECEMBER 2010, FIFTY-NINE PATIENTS UNDERWENT ND WITH PRIMARY HEAD AND NECK CANCER RESECTION WERE ENROLLED IN THIS STUDY. THE GROUP USING HS CONSISTED OF 29 PATIENTS (MALE=20, FEMALE=9; MEAN AGE=58.5 YEARS, AGE RANGE=32 ¿ 83 YEARS), AND THE CONVENTIONAL HAND-TIED LIGATION TECHNIQUE (CT) GROUP COMPRISED OF 30 PATIENTS (MALE=20, FEMALE=10; MEAN AGE=59.9 YEARS, AGE RANGE=38 ¿ 89 YEARS). DURING THE PROCEDURE, IN THE HS GROUP, THE HARMONIC FOCUS CURVED SHEARS (ETHICON) WAS USED FOR VASCULAR CONTROL OF THE SURGERY, REGARDLESS OF VESSEL DIAMETER. REPORTED COMPLICATION INCLUDED SEROMA FORMATION (N=2) WHICH WERE RESOLVED AFTER SIMPLE ASPIRATION AND COMPRESSIVE DRESSING. IN CONCLUSION, THE HS IS A RELATIVELY SAFE AND EFFECTIVE ALTERNATIVE METHOD FOR HAND-TIE LIGATION IN ND. MOREOVER, THE HS SIGNIFICANTLY REDUCED THE OPERATING TIME AND AMOUNT OF BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206509 UNK_ULTRACISION HARMONIC FOCUS INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GENERATOR AND HANDPIECE