BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORY CONTROL DISP. HAND CONTROL PENCIL

    MDR report key: 27258 · Received August 8, 1995

    Report

    Report Number
    27258
    Event Type
    Malfunction
    Date Received
    August 8, 1995
    Date of Event
    March 9, 1995
    Report Date
    April 26, 1995
    Manufacturer
    BIRTCHER MEDICAL SYSTEMS, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY THE PENCIL WOULD CUT BUT NOT CAUTERIZE. THE UINT SETTINGS WERE INCREASED BUT TO NO AVAIL. A NEW PENCIL WAS USED WITH THE SAME RESULT. THE MACHINE WAS CHANGED & A 3RD PENCIL WAS USED ALONG WITH NEW GROUNDING PADS. THE UNIT FUNCTIONED PROPERLY WITH THE 3RD PENCIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORY CONTROL DISP. HAND CONTROL PENCIL HAND CONTROL PENCIL WITH PUSH BUTTON SWITCH GEI BIRTCHER MEDICAL SYSTEMS, INC. J84373

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other