BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTON SWITCH PENCIL

    MDR report key: 2132506 · Received June 10, 2011

    Report

    Report Number
    2132506
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 10, 2011
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    THE OR STAFF WAS PREPARING FOR A PROCEDURE. THE ELECTROSURGICAL UNIT (ESU) WAS TURNED ON AND SET TO CUT "30", COAG COAGULATION "30". THE ESU ACTIVATED AND WOULD NOT STOP. NO ONE WAS TOUCHING THE UNIT OR SWITCHES. THE STAFF TURNED THE ESU OFF, REMOVED THE PENCIL, RE-INSERTED THE PENCIL AND TURNED THE UNIT BACK ON. WHEN THE UNIT TURNED ON THE SETTINGS READ CUT "194", COAG "0". THE UNIT WAS TURNED OFF THEN ON AGAIN AND THE SETTINGS WERE CHANGES TO THE ORIGINAL SETTINGS. USING THE SAME PENCIL, THE UNIT WORKED TEMPORARILY THEN CUT ACTIVATED AND WOULD NOT STOP. THE ESU SYSTEM WAS REPLACED WITH ANOTHER SYSTEM AND BIOMED BIOMEDICAL ENGINEERING WAS NOTIFIED. DURING BIOMEDICAL TESTING THE PROBE WAS CONSTANTLY ACTIVE AND EVENTUALLY FAILED. THE ESU TESTED FINE WITH ANOTHER PROBE AND WAS RETURNED TO SERVICE. THE DEFECTIVE PROBE IS BEING HELD IN BIOMED FOR FURTHER OBSERVATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUTTON SWITCH PENCIL ELECTROSURGICAL PENCIL GEI MEGADYNE MEDICAL PRODUCTS, INC * 2016-02 10388

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES