BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 22361057 · Received June 30, 2025

    Report

    Report Number
    3005075853-2025-04816
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    January 1, 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
    EG
    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. 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 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: LASER HEMORRHOIDOPLASTY PROCEDURE VERSUS HARMONIC SCALPEL HEMORRHOIDECTOMY: A COMPARATIVE STUDY FOR THE TREATMENT OF GRADES III AND IV HEMORRHOIDS AUTHOR(S): LOUTFY, EHAB; ELGOHARY, HATEM; ELKASHLAN, MAHMOUD E.; ABDELRAHMAN, MOHAMED G.; OMAR, WAEL. CITATION: THE EGYPTIAN JOURNAL OF SURGERY. THIS STUDY AIMED TO EVALUATE AND COMPARE THE OUTCOMES OF LASER HEMORRHOIDOPLASTY (LHP) AND HARMONIC SCALPEL HEMORRHOIDECTOMY (HSH) IN THE MANAGEMENT OF GRADES III AND IV HEMORRHOIDS, FOCUSING ON SOME POSTOPERATIVE COMPLICATIONS. A RANDOMIZED, CONTROLLED, CLINICAL TRIAL INVOLVING 34 PATIENTS WITH GRADES III AND IV HEMORRHOIDS WAS CONDUCTED FROM (B)(6) 2022 TO (B)(6) 2023. REPORTED COMPLICATION: BLEEDING (N-?) SEROMUCOUS DISCHARGE (N-?) PAIN (N-?) STENOSIS (N-?) INCONTINENCE (N-?) RECURRENCE (N-?). CONCLUSION: BOTH HSH AND LHP TECHNIQUES WERE FOUND TO BE SAFE AND EFFECTIVE FOR MANAGING HEMORRHOIDS. LHP DEMONSTRATED ADVANTAGES, INCLUDING LOWER POSTOPERATIVE PAIN LEVELS, REDUCED SEROMUCOUS DISCHARGE, AND FASTER WOUND HEALING COMPARED WITH HSH. THESE FINDINGS PROVIDE VALUABLE INSIGHTS FOR CLINICIANS IN OPTIMIZING PATIENT CARE DURING THE MANAGEMENT OF HEMORRHOIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929158 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GENERATOR