BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGADYNE E-Z CLEAN

    MDR report key: 8806880 · Received July 19, 2019

    Report

    Report Number
    8806880
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Date of Event
    June 17, 2019
    Report Date
    July 15, 2019
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MALFUNCTION OF MEGADYNE ULTRA VAC SURGICAL PENCIL TIP. AT THE BEGINNING OF SURGICAL PROCEDURE SURGEON NOTICED A SPARKING AT THE TIP OF SMOKE PENCIL TOWARDS THE SUCTION OF THE MEGADYNE ULTA VAC, WITH A QUICK FLARE-FLAME WHICH SURGEON IMMEDIATELY STOPPED USING. NO HARM TO PATIENT OR SURGICAL TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599873 MEGADYNE E-Z CLEAN ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI MEGADYNE MEDICAL PRODUCTS, INC. 0012AM 191998

    Patients

    Seq Age Sex Outcome Treatment
    1 20805 DA