BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 22365084 · Received June 30, 2025

    Report

    Report Number
    3005075853-2025-04902
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    April 19, 2024
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/30/2025. B3: PUBLICATION YEAR OF 2024. 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. ADDITIONAL INFORMATION: NO FURTHER INFORMATION WILL BE PROVIDED BECAUSE WE CAN¿T GET ANY ADDITIONAL INFORMATION FROM THE AUTHOR. 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 : COMPARISON OF LAPAROSCOPIC LIVER RESECTION FOR THE VENTRAL VERSUS THE DORSAL AREAS OF SEGMENT 8 AUTHOR : KENTARO OJI , MASAHIRO KIDO, SHOHEI KOMATSU, HIDETOSHI GON , NOBUAKI YAMASAKI, KENJI FUKUSHIMA , SHINICHI SO, TOSHIHIKO YOSHIDA , KEISUKE ARAI , MASAYUKI AKITA ,JUN ISHIDA YOSHIHIDE NANNO , DAISUKE TSUGAWA , SADAKI ASARI , HIROAKI YANAGIMOTO, HIROCHIKA TOYAMA, TAKUMI FUKUMOTO CITATIONS : LANGENBECK'S ARCHIVES OF SURGERY. PAGES,1-16. DOI HTTPS://DOI.ORG/10.21203/RS.3.RS-4209863/V1 THE AIM OF THIS STUDY WAS TO KNOW THE TECHNICAL DIFFICULTIES OF LAPAROSCOPIC LIVER RESECTION (LLR) ARE GREATLY ASSOCIATED WITH THE LOCATION OF LIVER TUMORS. SINCE SEGMENT 8 (S8) CONTAINS A WIDE AREA, THE DIFFICULTY OF LLR FOR S8 TUMORS MAY VARY DEPENDING ON THE LOCATION WITHIN THE SEGMENT, SUCH AS THE VENTRAL (S8V) AND DORSAL (S8D) AREA, BUT THE DIFFERENCE IS UNCLEAR. WE RETROSPECTIVELY INVESTIGATED 30 PATIENTS WHO UNDERWENT PRIMARY LAPAROSCOPIC PARTIAL LIVER RESECTION FOR LIVER TUMORS IN S8 AT KOBE UNIVERSITY HOSPITAL BETWEEN JANUARY 2018 AND JUNE 2023. LIVER PARENCHYMAL TRANSECTION WAS PERFORMED BY THE CLAMP CRUSHING METHOD USING AN ULTRASONIC VESSEL-SEALING SYSTEM (HARMONIC® HD1000I OR 1100; ETHICON ENDO-SURGERY INC., CINCINNATI, OH, USA) THE REPORTED COMPLICATIONS INCLUDED ABDOMINAL ABCESS (N=1) AND PROLONGED INFLAMMATION (N=4). IN CONCLUSION, THE SAFETY OF LLR FOR THE S8D WAS COMPARABLE TO THAT OF LLR FOR THE S8V, ALTHOUGH LLR FOR THE S8D RESULTED IN LONGER OPERATIVE TIME AND MORE BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2485134 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention