BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_HARMONIC FCS+

    MDR report key: 22359779 · Received June 30, 2025

    Report

    Report Number
    3005075853-2025-04812
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    March 22, 2024
    Report Date
    June 30, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K132612
    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. 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.

    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): EHAB LOUTFY, HATEM ELGOHARY, MAHMOUD E. ELKASHLAN, MOHAMED G. ABDELRAHMAN, WAEL OMAR CITATION: THE EGYPTIAN JOURNAL OF SURGERY 2024, 43:572¿578; DOI: 10.4103/EJS.EJS_325_23. THIS STUDY AIMED TO EVALUATE AND COMPARE THE OUTCOMES OF LASER HEMORRHOIDOPLASTY AND HARMONIC SCALPEL HEMORRHOIDECTOMY IN THE MANAGEMENT OF GRADES III AND IV HEMORRHOIDS, FOCUSING ON SOME POSTOPERATIVE COMPLICATIONS. THE STUDY SPANNED FROM JUNE 2022 TO MARCH 2023. 34 PATIENTS WITH GRADES III AND IV HEMORRHOIDS WERE INCLUDED IN THE STUDY. PATIENTS WERE RANDOMLY ALLOCATED INTO ONE OF TWO GROUPS, GROUP A (LASER HEMORRHOIDOPLASTY) COMPRISING 17 PATIENTS AND GROUP B (HARMONIC SCALPEL HEMORRHOIDECTOMY) WITH 17 PATIENTS. GROUP A WAS COMPOSED OF 12 MALES AND 5 FEMALES WITH A MEAN AGE OF 36.0±10.85 YEARS. GROUP B WAS COMPOSED OF 9 MALES AND 8 FEMALES WITH A MEAN AGE OF 41.65±8.83 YEARS. IN GROUP A, A COMPETITOR¿S LASER WAS USED (MANUFACTURER: GIGAALASER GROUP). IN GROUP B, THE HARMONIC SCALPEL (HARMONIC FOCUS+SHEARS, WITH A GEN11 GENERATOR BY ETHICON) WAS USED. REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE BLEEDING 24 HOURS POSTOPERATIVE (N=3), POSTOPERATIVE BLEEDING AT1 WEEK POSTOPERATIVE (N=2), POSTOPERATIVE DISCHARGE 24 HOURS POSTOPERATIVE (N=7), POSTOPERATIVE DISCHARGE AT 1 WEEK POSTOPERATIVE (N=8), AND POSTOPERATIVE PAIN UNTIL 3 WEEKS POSTOPERATIVE (N=?). IN CONCLUSION, BOTH HARMONIC SCALPEL HEMORRHOIDECTOMY AND LASER HEMORRHOIDOPLASTY TECHNIQUES WERE FOUND TO BE SAFE AND EFFECTIVE FOR MANAGING HEMORRHOIDS. LASER HEMORRHOIDOPLASTY DEMONSTRATED ADVANTAGES, INCLUDING LOWER POSTOPERATIVE PAIN LEVELS, REDUCED SEROMUCOUS DISCHARGE, AND FASTER WOUND HEALING COMPARED WITH HARMONIC SCALPEL HEMORRHOIDECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234719 UNK_HARMONIC FCS+ SOFT-TISSUE ULTRASONIC SURGICAL SYSTEM HANDPIECE TIP, SINGLE-USE LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention