BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 20481102 · Received October 18, 2024

    Report

    Report Number
    3005075853-2024-07855
    Event Type
    Injury
    Date Received
    October 18, 2024
    Date of Event
    January 1, 2024
    Report Date
    October 18, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 10/18/2024 B3: PUBLICATION YEAR OF 2024 D4: BATCH # UNK . 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. ATTEMPTS ARE BEING 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.

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 7/3/2025. CORRECTED DATA: H6 HEALTH EFFECT - IMPACT CODE. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204.

    Description of Event or Problem · 0

    TITLE: LAPAROSCOPIC VERSUS OPEN LIVER RESECTION FOR MULTIPLE HEPATOCELLULAR CARCINOMA WITHIN AND BEYOND THE MILAN CRITERIA: AN EASTERN-WESTERN PROPENSITY SCORE-MATCHED ANALYSIS AUTHORS: GIANLUCA CASSESE I HO-SEONG HAN I EUNHYE LEE I BORAM LEE I HAE WON LEE I JAI YOUNG CHO I ROBERTO MONTALTI I ROBERTO IVAN TROISI CITATION: J HEPACOBILIARY PANCREAT SCI. 2024;31:2-11. DOI: 10.1002/JHBP.1384. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO ASSESS THE SHORT- AND LONG- TERM OUTCOMES OF LAPAROSCOPIC LIVER RESECTION (LLR) VERSUS OPEN LIVER RESECTION (OLR) FOR PATIENTS WITH MULTIPLE HEPATOCELLULAR CARCINOMAS (HCC) WITHIN AND BEYOND THE MILAN CRITERIA, AND IN BOTH BCLC-A AND -B STAGE. A TOTAL OF 218 PATIENTS UNDERWENT MULTIPLE LIVER RESECTION BETWEEN JANUARY 2010 TO JUNE 2022 AT TWO TERTIARY REFERRAL HPB CENTERS (SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL, SOUTH KOREA AND FEDERICO II UNIVERSITY HOSPITAL NAPLES, ITALY). AFTER APPLYING THE STUDY EXCLUSION CRITERIA, 203 PATIENTS WERE INITIALLY ENROLLED: 92 PATIENTS UNDERWENT OLR AND 111 UNDERWENT LLR. MEAN AGE WAS 62.4YEARS (±10.9), WITH 32 FEMALE PATIENTS (15.7%). THE LIVER PARENCHYMA WAS TRANSECTED BY A COMBINATION OF A HARMONIC SCALPEL (ETHICON, ENDO-SURGERY, USA) AND A LAPAROSCOPIC CAVITRON ULTRASONIC SURGICAL ASPIRATOR (CUSA, INTEGRA-FRANCE) OR LIGASURE (MEDTRONIC, USA). REPORTED COMPLICATIONS INCLUDE POSTOPERATIVE COMPLICATIONS (N=81) AND BILE LEAK (N=2). IN CONCLUSION, LLR FOR MULTIPLE HCC CAN BE SAFE AND EFFECTIVE IN SELECTED CASES AND IS ABLE TO SHORTEN MEDIAN HOSPITAL STAY WITHOUT AFFECTING PERIOPERATIVE AND LONG-TERM ONCOLOGICAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2209049 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention