BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 20042613 · Received August 22, 2024

    Report

    Report Number
    3005075853-2024-06210
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    January 1, 2024
    Report Date
    August 22, 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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 8/22/2024 B3: PUBLICATION YEAR OF 2024 D4 BATCH #: UNKNOWN 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. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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: ASSESSMENT OF HARMONIC SCALPEL VERSUS MONOPOLAR ELECTROCAUTERIZATION IN CHOLECYSTECTOMY AUTHORS: RAVI RANJAN, ET AL. CITATION: INTERNATIONAL JOURNAL OF LIFE SCIENCES, BIOTECHNOLOGY AND PHARMA RESEARCH VOL 13, NO 6. 2024 THE PRESENT STUDY WAS CONDUCTED TO COMPARE HARMONIC SCALPEL VERSUS MONOPOLAR ELECTROCAUTERIZATION IN CHOLECYSTECTOMY. BETWEEN AUGUST 2021 TO AUGUST 2023, 70 PATIENTS AGED 20 ¿70 YEARS; PHYSICAL STATUS CLASS I OR II, ACCORDING TO AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) DIAGNOSED WITH SIMPLE ACUTE OR CHRONIC CHOLECYSTITIS, CHOLELITHIASIS, SCHEDULED FOR LC WERE DIVIDED INTO 2 GROUPS OF 35 EACH. GROUP I PATIENTS UNDERWENT HARMONIC SCALPEL AND GROUP II CONVENTIONAL MONOPOLAR ELECTROCAUTERY. PARAMETERS SUCH AS OPERATIVE TIME, BLOOD LOSS, CONVERSION TO LAPAROTOMY, POSTOPERATIVE HOSPITAL STAY, POST-LC PAIN ETC. WERE RECORDED. REPORTED COMPLICATIONS INCLUDE UNKNOWN EVENT (N=2) REQUIRING CONVERSIONS TO LAPAROTOMY. IN CONCLUSION, FOR THE TREATMENT OF SIMPLE CHOLECYSTITIS AND CHOLELITHIASIS, LAPAROSCOPIC CHOLECYSTECTOMY UTILIZING TRADITIONAL MONOPOLAR ELECTROCAUTERY IS EQUALLY SAFE AND EFFECTIVE AS USING THE HARMONIC SCALPEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257616 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention