BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 22384283 · Received July 2, 2025

    Report

    Report Number
    3005075853-2025-05107
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    June 7, 2022
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/2/2025. B3: PUBLICATION YEAR OF 2022. D4: BATCH # UNK. 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

    TITLE: LAPAROSCOPIC LIVER RESECTION WITH ¿ULTRASONIC SCALPEL MIMIC CUSA" TECHNIQUE AUTHORS: YUBO YANG1 · YUFU PENG1 · KEFEI CHEN1 · YONGGANG WEI1 · BO LI1 · FEI LIU1 CITATION: SURGICAL ENDOSCOPY (2022), HTTPS://DOI.ORG/10.1007/S00464-022-09341-4. THE AIM OF THIS RETROSPECTIVE STUDY IS TO INTRODUCE A NOVEL TECHNIQUE FOR PARENCHYMAL TRANSECTION IN LLR USING THE HARMONIC SCALPEL, THE SO CALLED ¿HARMONIC MIMIC CUSA¿ TECHNIQUE. ADDITIONALLY, THIS STUDY WAS ALSO PERFORMED TO EVALUATE THE SAFETY AND EFFICACY OF THE ¿HARMONIC MIMIC CUSA¿ TECHNIQUE BY COMPARING WITH THE CUSA TECHNIQUE FOR LLR USING THE PROPENSITY SCORE MATCHING (PSM) METHOD. A TOTAL OF 298 PATIENTS WHO UNDERWENT LAPAROSCOPIC LIVER RESECTION (LLR) USING CUSA OR THE ¿HARMONIC MIMIC CUSA¿ FOR PARENCHYMAL TRANSECTION BETWEEN JULY 2018 AND OCTOBER 2020 WERE INCLUDED. CAVITRON ULTRASONIC SURGICAL ASPIRATOR (CUSA EXCEL, VALLEYLAB, CO, USA) WAS USED IN 106 PATIENTS (CUSA GROUP; 65 MALE AND 41 FEMALE; MEAN AGE OF 49 YEARS), WHILE THE ULTRASONIC SCALPEL (HARMONIC) WAS USED IN 192 PATIENTS (120 MALE AND 72 FEMALE; MEAN AGE OF 52.5 YEARS) USING THE ¿HARMONIC MIMIC CUSA¿ TECHNIQUE (HARMONIC GROUP). REPORTED COMPLICATIONS INCLUDE LIVER FAILURE (N=2), ASCITES (N=2), BILIARY LEAKAGE (N=1). IN CONCLUSION, THE ¿HARMONIC MIMIC CUSA¿ TECHNIQUE IS SAFE, SIMPLE AND FEASIBLE FOR LLR, WHICH MAY BE AN ALTERNATIVE TO CUSA FOR LLR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9003 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention