BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_ULTRACISION HARMONIC FOCUS

    MDR report key: 22372027 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-04949
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    November 1, 2020
    Report Date
    July 1, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/1/2025 B3: PUBLICATION YEAR OF 2020 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: EVALUATION OF ULTRASONIC AXILLARY DISSECTION IN PRESERVATION OF INTERCOSTOBRACHIAL NERVE AND LYMPHATIC SEALING IN BREAST CANCER PATIENTS: RANDOMIZED CONTROLLED TRIAL AUTHORS: AHMED M.F. SALAMA , AHMED M. NAWAR, MOHAMED E. ZAYED, MOHAMED S. ESSA CITATION CITE: ANNALS OF MEDICINE AND SURGERY 60 (2020) 255¿260 HTTPS://DOI.ORG/10.1016/J.AMSU.2020.10.059 THIS STUDY AIMS TO COMPARE THE MEAN AXILLARY DRAIN PRODUCTION AND THE AXILLARY NUMBNESS FREQUENCY IN AXILLARY LYMPH NODE DISSECTION (ANLD) DURING MODIFIED RADICAL MASTECTOMY (MRM) AND BREAST CONSERVATIVE SURGERY (BCS) BETWEEN THE USE OF HARMONICS SCALPEL AND ELECTROCAUTERY. THIS STUDY INCLUDES 40 PATIENTS PRESENTED WITH EARLY BREAST CANCER (T1 AND T2) UNDERWENT BCS OR MRM IN GENERAL SURGERY DEPARTMENT, FACULTY OF MEDICINE, BENHA UNIVERSITY HOSPITAL DURING THE PERIOD FROM JANUARY 2017 TO SEPTEMBER 2019. THE PATIENTS RANDOMLY ASSIGNED INTO 2 GROUPS; GROUP A: SUBJECTED TO ANLD USING HARMONIC FOCUS (ETHICON) TOOL AND GROUP B: SUBJECTED TO ANLD USING ELECTROCAUTERY. IN GROUP B PATIENTS THEY WERE LIGATED USING 3/0 VICRYL SUTURES (ETHICON). REPORTED COMPLICATIONS INCLUDED SEROMA (N=1), HEMATOMA (N=2), WOUND INFECTION (N=1) IN CONCLUSION COMPARED TO THE NORMAL ELECTROCAUTERY, THE HARMONIC FOCUS DISSECTION HAS MAJOR ADVANTAGES IN LOWERING POSTOPERATIVE DRAINAGE, BLOOD LOSS INTRA-OPERATIVE AND LOWER INCIDENCE OF AXILLARY NUMBNESS IN BREAST CANCER AXILLARY DISSECTION, WITHOUT AFFECTING OPERATING TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313397 UNK_ULTRACISION HARMONIC FOCUS INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GENERATOR