BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 22952083 · Received September 3, 2025

    Report

    Report Number
    1717344-2025-01144
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    February 21, 2025
    Report Date
    September 3, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPARATIVE STUDY OF COMPLICATIONS AND SAFETY OF HEMORRHOIDECTOMY WITH LIGASURE AND HEMORRHOIDECTOMY WITH FERGUSON: A RANDOMIZED CONTROLLED CLINICAL TRIAL / GANGESH LAL DEO / INTERNATIONAL JOURNAL OF CURRENT PHARMACEUTICAL REVIEW AND RESEARCH 2025; 17(3); 2166-2170 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE PERFORMED BETWEEN FEBRUARY 2022 AND NOVEMBER 2023, A STUDY EVALUATED THE EFFECTIVENESS, COMPLICATIONS, AND SAFETY OF HEMORRHOIDECTOMY WITH LIGASURE COMPARED TO A CONVENTIONAL HEMORRHOIDECTOMY. THE STUDY INCLUDED 54 PATIENTS WHO WERE DIVIDED INTO TWO GROUPS OF LIGASURE AND F (NON-MEDTRONIC) SURGERY, WITH 27 PATIENTS IN EACH GROUP. THERE WERE SIX PATIENTS WITH COMPLICATIONS IN THE LIGASURE GROUP AND INCLUDED BURN WOUNDS, ANAL STENOSIS, AND FISSURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2322597 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Unknown Other