BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 22373724 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-04984
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    January 1, 2014
    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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/1/2025. B3: PUBLICATION YEAR OF 2014. D4: BATCH # UNK. 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS 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: TLH MADE MORE SAFE BY TACKLING UTERINE ARTERY AT ORIGIN. AUTHOR: TRIVEDI, PH. CITATION: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY 21 (2014) S178. THIS COMPARATIVE EVALUATION STUDY AIMED TO EVALUATE BLEEDING, POSSIBILITY IN DIFFICULT PATHOLOGY & SPECIALLY URETERIC OR VESICAL INJURY FROM SKELETONIZATION OF UTERINES FOLLOWED BY BIPOLAR OR SUTURING, VESSEL SEALING DEVICES & TACKLING UTERINE ARTERY AT THE ORIGIN FROM INTERNAL ILIAC ARTERY. FROM FEBRUARY 1994 TO MARCH 2014, A TOTAL OF 2373 LAPAROSCOPIC HYSTERECTOMY WERE INCLUDED IN THIS STUDY. OUT OF THESE SURGERIES, 603 CASES USED A VESSEL SEALING DEVICES INCLUDING THE HARMONIC ACE (ETHICON). COMPLAINT INCLUDED URETERIC INJURY (N=3) IN CASES WHERE HARMONIC ACE WAS USED. THE RESULTS OF THIS STUDY SHOWED THAT TACKLING UTERINE ARTERY DIRECTLY AT THE ORIGIN SHOULD BE DONE DURING TLH ON REGULAR BASIS TO REDUCE OR AVOID URETERIC INJURY WHICH WAS HIGHEST IN VESSEL SEALING DEVICE OR HARMONIC ACE DUE TO LATERAL SPREAD OF HEAT OR DIRECT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430163 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