BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 10165930 · Received June 17, 2020

    Report

    Report Number
    1717344-2020-00640
    Event Type
    Injury
    Date Received
    June 17, 2020
    Report Date
    June 17, 2020
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE RADIOFREQUENCY HEMORRHOIDECTOMY: RESULTS OF A COMPARATIVE STUDY USING TWO DIFFERENT DEVICE FOR A COST EFFECTIVE PROCEDURE SOURCE THE ASSOCIATION OF COLOPROCTOLOGY OF GREAT BRITAIN AND IRELAND., VOLUME 21, 2019 (33¿128) ARTICLE NUMBER: 3 DATE OF PUBLICATION: 2019. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, A HEMORRHOIDECTOMY PROCEDURE USING THE DEVICE. BETWEEN JANUARY 2016 AND DECEMBER 2018, 200 CONSECUTIVE PATIENTS WITH SYMPTOMATIC GRADE III AND IV WERE SCHEDULED FOR SURGICAL TREATMENT. ALL PREOPERATIVE AND POSTOPERATIVE DATA WERE COLLECTED. POST-OPERATIVELY, IT WAS REPORTED ONE PATIENT IN THE DEVICE'S GROUP EXPERIENCED STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626639 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other