BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGI

    MDR report key: 14286017 · Received May 5, 2022

    Report

    Report Number
    9680952-2022-00035
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Date of Event
    April 28, 2022
    Report Date
    May 25, 2022
    Manufacturer
    SURGICAL INNOVATIONS LTD
    Product Code
    GEI
    PMA / PMN Number
    K063485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A LOGI INSERT CAUSED BURNS TO STRUCTURES THAT THE DEVICE WAS LEANING AGAINST WHILST COAGULATING.

    Description of Event or Problem · 0

    A LOGI INSERT CAUSED BURNS TO STRUCTURES THAT THE DEVICE WAS LEANING AGAINST WHILST COAGULATING - OUR INITIAL AWARENESS OF THE ISSUES. A DESCRIPTION FROM THE DISTRIBUTER REP WAS OBTAINED 24 MAY 2022 - 'OPERATING SURGEON WAS PERFORMING A CUT DOWN HERNIA PROCEDURE. DURING THE PROCEDURE HE USED THE ECOCUT SCISSORS TO COAGULATE TISSUING USING THE VALLEYLAB FT10 ENERGY GENERATOR. THE SURGEON SELECTED A SETTING OF 30 ON COAG FULGURATE ON THE GENERATOR. IT IS REPORTED THAT ADJACENT TISSUE TO THE SCISSORS, APPEARED TO DENATURE, POSSIBLY DUE TO HEAT. THE SURGEON SWITCHED TO ANOTHER BRAND OF SCISSORS TO COMPLETE THE PROCEDURE.' NO SIGNIFICANT PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749625 LOGI LOGI INSERT (ECOCUT) GEI SURGICAL INNOVATIONS LTD ECO-100 735475

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other