BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_ULTRACISION HARMONIC FOCUS

    MDR report key: 15455348 · Received September 20, 2022

    Report

    Report Number
    3005075853-2022-06250
    Event Type
    Injury
    Date Received
    September 20, 2022
    Date of Event
    January 1, 2022
    Report Date
    September 20, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2022. BATCH # UNK. 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: A NOVEL TECHNIQUE USING ULTRASONIC SHEARS VERSUS TRADITIONAL METHODS OF REDUCTION OF BILATERAL LABIA MINORA HYPERTROPHY: A RETROSPECTIVE CASE-CONTROL STUDY AUTHORS: MAJ, THUAN H. LE, USAF, MC; COL(R), ERNEST G. LOCKROW, MC, USA; MAJ, SCOTT P. ENDICOTT, MC, USAMAJ, THUAN H. LE, USAF, MC; COL(R), ERNEST G. LOCKROW, MC, USA; MAJ, SCOTT P. ENDICOTT, MC, USA. CITATION: MILITARY MEDICINE, VOL. 00, MONTH/MONTH 2022. THIS PAPER INTENDS TO EVALUATE THE SURGICAL OUTCOMES OF USING ULTRASONIC TECHNOLOGY, THE HARMONIC FOCUS+ SHEARS, IN LABIAL HYPERTROPHY REDUCTION IN COMPARISON TO OTHER TRADITIONAL METHODS. IN THIS RETROSPECTIVE STUDY, WE EVALUATE THE SURGICAL OUTCOMES OF 11 WOMEN WHO UNDERWENT BILATERAL LABIA MINORA HYPERTROPHY REDUCTION USING ULTRASONIC SHEARS TO 14 WOMEN WHO UNDERWENT THE SAME PROCEDURE USING VARIOUS TRADITIONAL METHODS BETWEEN JANUARY 1, 2015 AND FEBRUARY 29, 2020. IMPLANTS USED FOR THE ULTRANSONIC SHEARS WAS THE HARMONIC FOCUS+SHEARS (ETHICON, CINCINNATI, OHIO). A 5 MM SEPARATION OF THE TISSUE EDGES OCCURRED IN ONE CASE ON POSTOPERATIVE DAY FOUR WHICH REQUIRED A SINGLE INTERRUPTED SUTURE REPAIR. ULTRASONIC SHEARS SIGNIFICANTLY REDUCE THE TIME NEEDED FOR THE REDUCTION OF BILATERAL LABIA MINORA HYPERTROPHY AND THEREFORE SHOULD BE CONSIDERED BY SURGEONS AS A USEFUL TOOL IN INCREASING THE EFFICIENCY OF THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2484024 UNK_ULTRACISION HARMONIC FOCUS SOFT-TISSUE ULTRASONIC SURGICAL SYSTEM HANDPIECE TIP, SINGLE-USE LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention