BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 22383158 · Received July 2, 2025

    Report

    Report Number
    3005075853-2025-05075
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    June 29, 2023
    Report Date
    July 2, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/2/2025. B3: PUBLICATION YEAR OF 2023. 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 BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA: 014204. 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. ATTEMPTS WERE MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE, NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. 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: IMPACT OF CURRENT TECHNOLOGY IN LAPAROSCOPIC ADRENALECTOMY: 20 YEARS OF EXPERIENCE IN THE TREATMENT OF 254 CONSECUTIVE CLINICAL CASES. AUTHORS: GIOVANNI CONZO 1, RENATO PATRONE 2,3, LUIGI FLAGIELLO 1, ANTONIO CATAURO 1, ALESSANDRA CONZO 1, CHIARA CACCIATORE 1, FEDERICO MARIA MONGARDINI 1, GIOVANNI COZZOLINO 1, ROSETTA ESPOSITO 1, DANIELA PASQUALI 4, GIUSEPPE BELLASTELLA 5, KATHERINE ESPOSITO 6 AND LUDOVICO DOCIMO 1. CITATION: J. CLIN. MED. 2023;12(4384):1-11. HTTPS://DOI.ORG/10.3390/JCM12134384. THE AIM OF THIS RETROSPECTIVE STUDY IS TO ASSESS TECHNIQUE SAFETY, PATIENT OUTCOMES AND THE IMPACT OF NEW SURGICAL TOOLS. BETWEEN JANUARY 2003 AND DECEMBER 2022, A TOTAL OF 254 PATIENTS [103 MALE AND 151 FEMALE; AVERAGE AGE WAS 53.2 YEARS (RANGE 22¿79)] WHO UNDERWENT LAPAROSCOPIC ADRENALECTOMY (LA) IN THE TREATMENT OF ADRENAL NEOPLASM WERE INCLUDED IN THE STUDY. DURING THE FIRST YEARS OF EXPERIENCE, A MONOPOLAR HOOK WAS UTILIZED. SUCCESSIVELY, A HARMONIC SCALPEL (HS) (ETHICON ENDOSURGERY, INC., CINCINNATI, OH, USA), LIGASURE VESSEL SEALING SYSTEM (LS) (TYCO VALLEYLAB, BOULDER, 20052 MONZA, ITALY) AND THUNDERBEAT (TB) (OLYMPUS EUROPA SE & CO., HAMBURG, GERMANY) WERE UTILIZED AS ADVANCED HEMOSTASIS DEVICES, ABLE TO SEAL AND CUT VESSELS WITH THE APPLICATION OF DIFFERENT MODALITIES OF ENERGY (RADIOFREQUENCY, ULTRASOUND OR BOTH). FIBRIN SEALENT TISSUCOL¿TESSEEL (BAXTER, DEERFIELD, IL, USA), FLOSEAL HEMOSTATIC MATRIX (BAXTER), HEMOPATCH® (BAXTER) AND TABOTAMP® WERE ALSO SELECTIVELY UTILIZED TO ACHIEVE A BETTER HEMOSTATIC CONTROL. THE MEAN FOLLOW-UP PERIOD WAS 43.52 MONTHS (4¿150). REPORTED COMPLICATIONS INCLUDE ABDOMINAL WALL HEMATOMAS (N=?) AND INFECTION OF THE SURGICAL SITE (N=?). IN CONCLUSION, LA IS A SAFE PROCEDURE, EVEN FOR MASSES LARGER THAN 6 CM AND PCCS. UNDOUBTEDLY, THE DEVELOPMENT OF SURGICAL TECHNOLOGY HAS MADE IT POSSIBLE REDUCING OPERATIVE TIMES, PERFORMING A ¿CLIPLESS¿ ADRENALECTOMY AND EXTENDING THE INDICATIONS IN THE TREATMENT OF MORE COMPLEX PATIENTS. A MULTIDISCIPLINARY TEAM, IN REFERRAL HIGH-VOLUME CENTERS, IS RECOMMENDED IN THE MANAGEMENT OF ADRENAL PATHOLOGY. A 30-PROCEDURE LEARNING CURVE IS NECESSARY TO IMPROVE SURGICAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2218 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention