BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEICA MICROSYSTEMS

    MDR report key: 2923390 · Received October 11, 2006

    Report

    Report Number
    1423337-2006-00001
    Event Type
    Other
    Date Received
    October 11, 2006
    Date of Event
    July 3, 2006
    Report Date
    October 11, 2006
    Manufacturer
    LEICA MICROSYSTEMS, INC.
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON SITE LAMP TEST PROCEDURE COMPLETED WITH THE FOLLOWING FINDINGS: THE HEAT READING ON THIS UNIT WAS 652KL WHICH IS WITHIN ACCEPTABLE TOLERANCE. THERE WERE NO VISIBLE SIGNS OF DAMAGE OR DISCOLORATION ON THE UNIT. BLACK METAL TEST WAS CONDUCTED AT WD 275MM; A SENSING METER PLACED 12 INCHES FROM THE BOTTOM OF OPTICS CARRIER; TESTING TIME WAS FOR ONE CONTINUOUS HOUR. RESULTS WERE THAT THE METAL WAS NOT EVEN WARM WHEN TOUCHED. ON SITE INTERVIEW OF OPERATING ROOM PERSONNEL AND USE OF INSTRUMENT WAS CONDUCTED. STAFF WAS AWARE OF THE WARNING LABELS ON THE INSTRUMENT. STAFF IS AWARE OF THE CORRELATION BETWEEN WORKING DISTANCE AND HEAT. AGREEMENT WAS RECEIVED FROM STAFF THAT MICROSCOPE WORKED WITHIN ACCEPTABLE PERFORMANCE SPECIFICATIONS. PROPER ADHERENCE TO SAFETY WARNINGS WOULD ELIMINATE BURN POSSIBILITIES.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A RHIZOTOMY WHEN IT WAS NOTED SHE SUSTAINED A HEAT BURN FROM THE LEICA MICROSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEICA MICROSYSTEMS SURGICAL MICROSCOPE IEO LEICA MICROSYSTEMS, INC. MS3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention