BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 22375268 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-05005
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    January 1, 2013
    Report Date
    July 1, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    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 : LAPAROSCOPIC RADICAL HYSTERECTOMY FOR CERVICAL CANCER-EXPERIENCE OF PRIVATE ONCOLOGIC CLINIC IN UKRAINE. AUTHOR : BAYDO S.V.; VINNYTSKA A.B.; GOLUB D.A.; SILVESTROV M.A.; PRYNDYUK S.I. CITATION: INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER. CONFERENCE: 18TH INTERNATIONAL MEETING OF THE EUROPEAN SOCIETY OF GYNAECOLOGICAL ONCOLOGY, ESGO 2013. LIVERPOOL UNITED KINGDOM. CONFERENCE PUBLICATION: (VAR.PAGINGS). 23 (8 SUPPL. 1) (PP 277), 2013 THE AIM OF THIS STUDY IS TO REPRESENT THE EXPERIENCE IN PERFORMING TOTALLY LAPAROSCOPIC RADICAL HYSTERECTOMY (TLRH) WITH PELVIC LYMPHODISSECTION (PLND) IN PATIENTS WITH CERVICAL CANCER SHOWING ANALYSIS OF MORBIDITY AND SHORT-TERM POSTOPERATIVE RESULTS. FROM 2010 TO 2013, A TOTAL OF 50 TLRH (PIVER III-IV) (MEAN AGE: 41.5 YEARS, RANGE: 30-62 YEARS) WITH PLND WERE PERFORMED FOR CERVICAL CANCER. FOR PERFORMING PLND HARMONIC SCALPEL (ETHICON) WAS APPLIED. COMPLAINTS INCLUDED SEROMA (N=1), AND LYMPHORRHEA (N=3). THE DATA IN THIS STUDY SHOWED THAT THE BENEFITS OF TLRH FOR CERVICAL CANCER ARE LOWER POSTOPERATIVE PAIN, SHORT HOSPITAL STAY, BETTER COSMETIC RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206477 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

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