BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 22366852 · Received June 30, 2025

    Report

    Report Number
    3005075853-2025-04911
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    April 15, 2023
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 6/30/2025 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. 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

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: LAPAROSCOPIC AND OPEN LIVER RESECTION FOR HEPATOCELLULAR CARCINOMA WITH TYPE 2 DIABETES MELLITUS: MULTICENTER PROPENSITY SCORE-MATCHED STUDY. AUTHORS: SHI-YE YANG1 · JIN-KAI FENG1 · MAO-LIN YAN2 · LEI GUO1 · YUN-FEI DUAN3 · JIA-ZHOU YE4 · ZONG-HAN LIU1 · YAN-JUN XIANG1 · LI XU5 · JIE XUE1 · JIE SHI1 · WAN YEE LAU6 · SHU-QUN CHENG1 · WEI-XING GUO1. CITATION: HEPATOLOGY INTERNATIONAL (2023) 17:1251¿1264. HTTPS://DOI.ORG/10.1007/S12072-023-10492-2. THIS MULTICENTER STUDY AIMED AT ANALYZING AND COMPARING THE PERIOPERATIVE RESULTS AND LONG-TERM ONCOLOGICAL OUTCOMES OF HEPATOCELLULAR CARCINOMA (HCC) PATIENTS WITH TYPE 2 DIABETES MELLITUS (T2DM) TREATED WITH LAPAROSCOPIC (LLR) VERSUS OPEN LIVER RESECTION (OLR). BETWEEN JANUARY 2014 TO DECEMBER 2017, A TOTAL OF 230 PATIENTS WERE INCLUDED IN THIS STUDY, WITH 101 PATIENTS IN THE LLR GROUP AND 129 PATIENTS IN THE OLR GROUP. AMONG THE 230 PARTICIPANTS, 84.8% WERE MALES, AND MEDIAN PATIENT AGE WAS 65 (INTERQUARTILE RANGE [IQR] 57¿71, RANGE 24¿84) YEARS. DURING THE LAPAROSCOPIC LIVER RESECTION, A HARMONIC SCALPEL (ETHICON, SOMERVILLE, NJ, USA) AND LIGASURE (VALLEYLAB, INC.) WERE USED TO TRANSECT THE LIVER PARENCHYMA, AND ENDOCLIPS OR HEM-O-LOK CLIPS WERE USED TO SECURE SMALL HEPATIC VESSELS. THE MEDIAN FOLLOW-UP TIME OF THE WHOLE COHORT WAS 55.0 MONTHS (95% CI 48.2¿61.9 MONTHS). REPORTED COMPLICATIONS INCLUDE BILE FISTULA (N=?), ABDOMINAL INFECTION (N=?), AND INCISION ABSCESS (N=?). IN CONCLUSION, LAPAROSCOPIC LIVER RESECTION FOR HCC PATIENTS WITH T2DM CAN BE SAFELY PERFORMED WITH FAVORABLE PERIOPERATIVE AND LONG-TERM ONCOLOGICAL OUTCOMES AT HIGH-VOLUME LIVER CANCER CENTERS, REGARDLESS OF THE COURSE OF T2DM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315050 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention