BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-Z CLEAN

    MDR report key: 6935099 · Received October 10, 2017

    Report

    Report Number
    6935099
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    August 25, 2017
    Report Date
    September 18, 2017
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BOVIE TIP SPARKED AND THE BOVIE TIP MELTED. THERE WAS APPARENTLY AN ARCHING FROM THE BOVIE TIP TO OTHER PARTS OF THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718113 E-Z CLEAN ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEGADYNE MEDICAL PRODUCTS, INC. 0012AMD

    Patients

    Seq Age Sex Outcome Treatment
    1 ELECTROSURGICAL GENERATOR