BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 15455220 · Received September 20, 2022

    Report

    Report Number
    3005075853-2022-06249
    Event Type
    Injury
    Date Received
    September 20, 2022
    Date of Event
    November 25, 2020
    Report Date
    September 20, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: (B)(6) 2022. PUBLICATION YEAR OF 2021. 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: 7/7/2025. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CORRECTED DATA: D1, D4, H6. 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: COMPARISON OF NEW VERSUS REUSED HARMONIC SCALPEL PERFORMANCE IN LAPAROSCOPIC APPENDECTOMY IN PATIENTS WITH ACUTE APPENDICITIS¿A RANDOMIZED CLINICAL TRIAL AUTHORS: JAKOV MIHANOVIC, NATA¿A LISICA ¿IKIC, IVANA MRKLIC, ZVONIMIR KATU¿IC, ROBERT KARLO, MIRO JUKIC, ANA JERONCIC, ZENON POGORELIC CITATION: LANGENBECK'S ARCHIVES OF SURGERY (2021) 406:153¿162, HTTPS://DOI.ORG/10.1007/S00423-020-02039-Y THE AIM OF THIS STUDY WAS TO COMPARE LATERAL THERMAL DAMAGE OF THE APPENDIX AND CLINICAL OUTCOMES AFTER LAPAROSCOPIC APPENDECTOMY USING NEW VERSUS REUSED HARMONIC SCALPELS. BETWEEN MAY 2019 AND APRIL 2020, 100 PATIENTS (56% MALE) WHO UNDERWENT LAPAROSCOPIC APPENDECTOMY BECAUSE OF ACUTE APPENDICITIS WERE INCLUDED IN THE STUDY. ALL PATIENTS UNDERWENT LAPAROSCOPIC APPENDECTOMY USING THE HARMONIC SCALPEL (HARMONIC ACE® + SHEARS, ETHICON ENDO-SURGERY). USING A COMPUTER RANDOM NUMBER GENERATOR, THE PATIENTS WERE ASSIGNED TO 1 OF 2 GROUPS: NEW DEVICE GROUP AND REUSED DEVICE GROUP. IN THE NEW DEVICE GROUP, THERE WERE 49 PATIENTS WITH 29 MALES AND FEMALES WITH A MEAN AGE OF 13 YEARS AND A MEAN BMI OF 20.1 KG/M2. IN THE REUSED DEVICE GROUP, THERE WERE 51 PATIENTS WITH 27 MALES AND 24 FEMALES WITH A MEAN AGE OF 15 YEARS AND A MEAN BMI OF 19.8 KG/M2. PATIENTS WERE FOLLOWED UP DURING THE 30-DAY PERIOD FOR DETECTION OF POSSIBLE LATE COMPLICATIONS OR READMISSIONS. THE REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE ABSCESS WITH FEVER (N=2), REUSE OF A SINGLE-USE DEVICE (N=51), UNACCEPTABLE HEMOSTASIS OF A REUSED DEVICE (N=1), UNACCEPTABLE CUTTING EFFICIENCY OF A REUSED DEVICE (N=1), AND UNACCEPTABLE FORCE APPLIED FOR DISSECTION OF A REUSED DEVICE (N=1). IN CONCLUSION, THE RESULTS OF OUR STUDY SUPPORT THE REUSE OF HARMONIC SCALPELS ESPECIALLY IN THE SETTINGS WHERE ECONOMIC CONSTRAINTS MIGHT HAMPER ACCESS TO MINIMALLY INVASIVE SURGERY TO A LARGER NUMBER OF PATIENTS. THE RESULTS OBTAINED ON LAPAROSCOPIC APPENDECTOMY MIGHT NOT BE REPRODUCIBLE TO OTHER MORE DEMANDING SURGICAL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2551148 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention