BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 22376112 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-05039
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    February 7, 2000
    Report Date
    July 1, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 7/1/2025. B3: PUBLICATION YEAR OF 2000. 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: MODIFIED RADICAL MASTECTOMY USING HARMONIC SCALPEL. AUTHOR : S.V.S. DEO, MS AND N.K. SHUKLA, CITATION: J. SURG. ONCOL. 2000; 74:204¿207. THIS STUDY WAS PERFORMED TO EVALUATE THE FEASIBILITY OF USING ULTRASONIC ENERGY (HARMONIC SCALPEL) FOR MODIFIED RADICAL MASTECTOMY (MRM) AND TO STANDARDISE THE OPERATIVE TECHNIQUE OF HARMONIC SCALPEL MRM USING VARIOUS AVAILABLE ACCESSORIES OF THE HARMONIC SCALPEL. A TOTAL OF 14 PATIENTS WITH BREAST CANCER UNDERWENT MRM. IN THE PROCEDURE, THE SECOND-GENERATION HARMONIC SCALPEL (ULTRACISION) MANUFACTURED BY ETHICON ENDO SURGERY, INC. (USA) WAS USED TO PERFORM THE SURGERY. POSTOPERATIVELY, ONLY ONE PATIENT DEVELOPED A SEROMA THAT WAS MANAGED BY ASPIRATION. THERE WERE NO HEMATOMAS OR FLAP NECROSES. HARMONIC SCALPEL IS A MULTIFUNCTIONAL INSTRUMENT, AND A GOOD TISSUE DISSECTION AND HAEMOSTASIS COULD BE ACHIEVED WITH COAGULATING SHEARS (CS). IT DOES NOT PROLONG THE OPERATING TIME. EVEN THOUGH THE MORBIDITY DATA IN OUR STUDY IS ENCOURAGING, THE NUMBER OF THE PATIENTS IS TOO SMALL TO DRAW ANY DEFINITIVE CONCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381281 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

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