BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_ULTRACISION HARMONIC FOCUS

    MDR report key: 22378409 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-05032
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    January 1, 2012
    Report Date
    July 1, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/1/2025 B3: PUBLICATION YEAR OF 2012 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: EVALUATION OF THE HARMONIC SCALPEL IN BREAST CONSERVING AND AXILLARY STAGING SURGERY AUTHOR : SHUO-HUI HUNG A,B, DACHEN CHU B,C, FOR-MOON CHEN B, TOM CHEN D, RAN-CHOU CHEN CITATION: JOURNAL OF THE CHINESE MEDICAL ASSOCIATION 75 (2012) 519-523; DOI: HTTP://DX.DOI.ORG/10.1016/J.JCMA.2012.07.006. THIS RETROSPECTIVE STUDY AIMED TO COMPARE THE RESULTS BETWEEN USING THE HARMONIC FOCUS (HF) DEVICE IN BREAST-CONSERVING SURGERY (BSC) AND AXILLARY STAGING SURGERY OR PROCEEDING USING CONVENTIONAL METHOD (CMS). FOR A PERIOD OF 2 YEARS FROM JAN2009 TO DEC2010, 89 FEMALE PATIENTS UNDERWENT BSC AND WERE ALLOCATED INTO TWO GROUPS BASED ON THE DEVICE USED IN SURGERY: HF GROUP (N=41; MEAN AGE OF 55.3±12.3 YEARS) AND CM GROUP (N=48; MEAN AGE OF 50.9±9.4 YEARS). THE PATIENTS WERE FURTHER DIVIDED INTO THE SENTINEL LYMPH NODE BIOPSY (SLNB) SUBGROUP (N=13 HF GROUP; N=21 CM GROUP) AND THE AXILLARY LYMPH NODE DISSECTION (ALND) SUBGROUP (28 HF GROUP; N=27 CM GROUP). IN THE HF GROUP, THE HF SCALPEL WAS USED EXCLUSIVELY FOR ALL DISSECTION, CUTTING, AND HEMOSTASIS, WITHOUT THE USE OF THE CLAMP-AND-TIE TECHNIQUE. POWER LEVEL 5 WAS APPLIED IN THE BREAST DISSECTION AND POWER LEVEL 3 WAS USED IN THE AXILLARY DISSECTION, CLOSE TO THE NERVE TO MAXIMIZE SAFETY. IN HF GROUP, POSTOPERATIVE COMPLICATIONS INCLUDED SEROMA (N=6) REQUIRING ASPIRATION FOLLOWING DRAIN REMOVAL (N=3); AND NUMBNESS (N=8; N=7 ALND AND N=1 SLNB). SEROMA FORMATION IS THE MOST COMMONLY EARLY SEQUELA TO BREAST CANCER SURGERY. PREVIOUS LITERATURE HAS SUGGESTED THAT THE INCREASED INCIDENCE OF SEROMA FORMATION WAS ATTRIBUTABLE TO THE THERMAL TRAUMA FROM ELECTROCAUTERY DISSECTION. HF MAY BE SAFER THAN ELECTROCAUTERY FOR DISSECTION NEAR THE NERVES. IN OUR STUDY, THE NUMBER OF PATIENTS WITH AXILLARY NUMBNESS AFTER THEIR ALND WAS SIGNIFICANTLY REDUCED IN THE HF GROUPS. THIS MAY BE ATTRIBUTABLE TO THE LOWER HEAT SPREAD AND THE LACK OF RISK OF ELECTRICAL INJURY FROM THE HF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142941 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