BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTAHLOOP ELECTROSURGICAL ELECTRODE GUIDE

    MDR report key: 11655391 · Received April 12, 2021

    Report

    Report Number
    MW5100723
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    April 7, 2021
    Report Date
    April 9, 2021
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UTAHLOOP ELECTROSURGICAL ELECTRODE GUIDE MELTED WHILE IN USE. NO HARM TO PATIENT. ELECTRODE AND GUIDE CHANGED, PROCEDURE COMPLETED WITHOUT INCIDENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551591 UTAHLOOP ELECTROSURGICAL ELECTRODE GUIDE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI UTAH MEDICAL PRODUCTS, INC. DLP-W11 1192469

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR