BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 22365710 · Received June 30, 2025

    Report

    Report Number
    3005075853-2025-04913
    Event Type
    Injury
    Date Received
    June 30, 2025
    Report Date
    June 30, 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: 6/3/2025 D4: BATCH # UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY 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. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY 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 WITH LYMPHADENECTOMY IN CERVICAL CANCER: OUR TECHNIQUE AND EXPERIENCE. AUTHOR/S: D. LIMBACHIYA, P. GANDHI, M. KENKRE, S. SHAH, H. CHAWLA, G. AGRAWAL,S. SORANA. WEB ADDRESS: CITATION: EUROPEAN JOURNAL OF GYNAECOLOGICAL ONCOLOGY XI.,N.3,2019, 394-401; DOI:10.12892/EJGO4660.2019. THIS RETROSPECTIVE STUDY AIMED TO DESCRIBE THE TECHNIQUE OF TOTAL LAPAROSCOPIC RADICAL HYSTERECTOMY (LRH) IN CERVICAL CANCER. BETWEEN FEBRUARY 2009 AND JUNE 2017, A TOTAL OF 53 PATIENTS (MEDIAN AGE: 47 YEARS, AGE RANGE: 28-70 YEARS, MEDIAN BMI: 25.7 KG/M2, BMI RANGE: 16-32 KG/M2) DIAGNOSED WITH CERVICAL CANCER UNDERWENT LRH WITH BILATERAL LYMPHADENECTOMY. THE HARMONIC SHEARS (ETHICON) WAS USED TO INCISE UTEROVESICAL FOLD, CUT LOOSE CONNECTIVE TISSUE LATERAL TO THE BLADDER PILLAR, CUT LEFT ROUND LIGAMENT, INCISE PERITONEUM BETWEEN TWO-UTEROSACRAL LIGAMENTS, DISSECT ALL FIBRO-FATTY TISSUE AROUND UTERINE ARTERY, COAGULATE AND CUT INFUNDIBULOPELVIC LIGAMENT, COAGULATED AND CUT UTERINE ARTERY, TRANSECT PARAMETRIUM, PARACERVICAL, AND PARACOLPUS TISSUES, CUT OPEN THE FORNIX FROM THE LEFT LATERAL ASPECT, RESECTION OF VAGINAL CUFF, AND REMOVAL OF LYMPHATIC TISSUES. THE VAGINAL CUFF WAS CLOSED LAPAROSCOPICALLY USING VICRYL NO. 1 (ETHICON) IN A CONTINUOUS FASHION FROM LEFT VAGINAL ANGLE TO THE RIGHT (NON-LOCKING). COMPLAINTS INCLUDED VESICOVAGINAL FISTULA (N=1), AND LYMPHOEDEMA (N=3). THE FISTULA WAS TREATED WITH THE INDWELLING CATHETER FOR SIX WEEKS AND THE FISTULA HEALED SPONTANEOUSLY. IN CONCLUSION, THE PRESENT TECHNIQUE OF LRH IS SAFE, FEASIBLE, AND ASSOCIATED WITH LESS MORBIDITY. IT IS ASSOCIATED WITH MINIMAL INTRAOPERATIVE COMPLICATIONS, BLOOD LOSS, SHORTER OPERATIVE TIME, AND OUTCOMES COMPARABLE TO OTHER STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327731 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention