BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELECTROSURGICAL UNIT

    MDR report key: 11070 · Received January 26, 1994

    Report

    Report Number
    MW1000492
    Event Type
    Other
    Date Received
    January 26, 1994
    Date of Event
    January 13, 1994
    Report Date
    January 21, 1994
    Manufacturer
    ELMED, INC.
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ANALYZER USING THE 500 OHM LOAD; 190W OF POWER WAS MEASURED IN BLEND ONE AT ALL INTENSITY SETTINGS AND 106W OF POWER WAS MEASURED IN BLEND TWO AT ALL INTENSITY SETTINGS. THE OUTPUT DISPLAY DISPLAYED NORMAL EXPECTED OUTPUT POWER WHEREAS ACTUAL POWER DELIVERED WAS EXTREMELY HIGH. PURE CUT AND COAG MODES FUNCTIONED NORMALLY. A MODIFICATION HAD BEEN MADE TO THE UNIT BY THE FACTORY IN WHICH A CIRCUIT WAS ADDED TO INCREASE THE ACCURACY OF THE DISPLAY WHEN THE UNIT IS USED IN THE BLEND MODES OF OPERATION. THIS CIRCUIT WAS CONSTRUCTED ON PERFORATED BOARD USING POINT TO POINT WIRING. A WIRE WAS FOUND TO BE SEPARATED FROM PIN 3 OF THE MC1458 IC SOCKET. THIS CAUSED THE OUTPUT OF THE MODIFIED CIRCUIT TO BE DRIVEN TO MAXIMUM OUTPUT WHICH IN TURN CAUSED THE OUTPUT OF THE ESU TO BE DRIVEN HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSURGICAL UNIT GEI ELMED, INC. ESU 300 M/M DIGITAL

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other