BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 22470062 · Received July 10, 2025

    Report

    Report Number
    3005075853-2025-05392
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    July 1, 2025
    Report Date
    July 10, 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: 7/10/2025 B3: PUBLICATION YEAR OF 2020 D4: BATCH # UNK D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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. 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: CLINICAL EFFECT OF AURICULAR ACUPUNCTURE COMBINED WITH MINIMALLY INVASIVE SURGERY IN TREATMENT OF HEPATOLITHIASIS. AUTHORS: LIYOU WANG. CITATION: DOI:10.13517/J.CNKI.CCM.2020.07.025. THIS STUDY AIMS TO INVESTIGATE AND ANALYZE THE CLINICAL EFFECT OF MINIMALLY INVASIVE SURGERY COMBINED WITH AURICULAR ACUPUNCTURE IN THE TREATMENT OF HEPATOLITHIASIS. BETWEEN MAY 2017 TO MAY 2018, 82 PATIENTS WITH HEPATOLITHIASIS WERE RANDOMLY DIVIDED INTO TEST CONTROL GROUP (N = 41) AND CONTROL GROUP (N = 41). THE CONTROL GROUP WAS TREATED WITH OPEN ANATOMICAL LEFT HEMIHEPATECTOMY, AND THE EXPERIMENTAL GROUP WAS TREATED WITH LAPAROSCOPIC ANATOMICAL LEFT HEMIHEPATECTOMY USING GENERAOR ULTRASOUND KNIFE PRODUCED BY JOHNSON & JOHNSON, COMBINED WITH AURICULAR ACUPUNCTURE AFTER SURGERY. REPORTED COMPLICATIONS ARE GENERAOR ULTRASOUND KNIFE PRODUCED BY JOHNSON & JOHNSON. N=1 BILE LEAKAGE TREATMENT: NOT REPORTED. N=1 CHOLANGITIS TREATMENT: NOT REPORTED. N=2 SUBPHRENIC ABSCESS TREATMENT: NOT REPORTED. N=1 ASCITES TREATMENT: NOT REPORTED. N=1 INFECTION TREATMENT: NOT REPORTED. IN CONCLUSION, LAPAROSCOPIC ANATOMICAL LEFT HEMIHEPATECTOMY COMBINED WITH AURICULAR ACUPUNCTURE FOR HEPATOLITHIASIS CAN ACHIEVE GOOD STONE CLEARANCE EFFECT WITH LESS SURGICAL TRAUMA AND COMPLICATIONS, WHICH IS BENEFICIAL TO THE RECOVERY OF PATIENTS AND REDUCES THE RECURRENCE OF STONES. IT IS WORTHY OF BEING WIDELY POPULARIZED IN THE CLINICAL APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774066 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other