BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTO-SURGE

    MDR report key: 520420 · Received March 26, 2004

    Report

    Report Number
    MW1031685
    Event Type
    Injury
    Date Received
    March 26, 2004
    Date of Event
    March 16, 2004
    Report Date
    March 18, 2004
    Manufacturer
    ELLMAN INTERNATIONAL INC.
    Product Code
    EKZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WHILE CALIBRATING THE DENTO-SURGE, RECEIVED AN ELECTRIC SHOCK/BURN. RPTR REMOVED THE OUTPUT POWER CONTROL KNOB TO ATTEMPT TO RE-ALIGN THE KNOB WITH THE PROPER CORRESPONDING EXPECTED OUTPUT. THE KNOB IS ATTACHED TO A PLASTIC STEM WHICH IS HELD IN PLACE BY A METAL SLEEVE CONNECTED TO THE PLASTIC STEM. RPTR RECEIVED A SHOCK/BURN ON THEIR RIGHT THUMB. UPON INSPECTING THE UNIT IN QUESTION RPTR NOTICED THAT THE METAL SLEEVE ON THE OUTPUT CONTROL KNOB IS DIRECTLY CONNECTED TO A POTENTIOMETER "VARI-CAPICITOR AS NOTED IN THE SERVICE MANUAL." THIS DESIGN IS VERY DANGEROUS AND CAN PRESENT AN UN-WANTED SHOCK TO THE OPERATOR WHILE TURNING THE KNOB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENTO-SURGE HYFRECATOR EKZ ELLMAN INTERNATIONAL INC. DENTO-SURGE F.F.P *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention