BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA OH5

    MDR report key: 3269174 · Received August 1, 2013

    Report

    Report Number
    MW5031284
    Event Type
    Injury
    Date Received
    August 1, 2013
    Date of Event
    July 16, 2013
    Report Date
    August 1, 2013
    Manufacturer
    LEICA MICROSYSTEMS INC.
    Product Code
    EPT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING RIGHT TYMPANOPLASTY SURGERY WITH THE AID OF A LEICA MICROSCOPE. AT THE COMPLETION OF THE PROCEDURE, IT WAS NOTED THAT THE SKIN ON THE UPPER PORTION OF THE EAR WAS SLIGHTLY DENUDED AND THERE WAS A SLIGHT BURN BEHIND THE EAR. THIS BURN WAS FELT TO BE DUE TO THE HEAT PRODUCED BY THE MICROSCOPE LIGHT. THE MICROSCOPE WAS INSPECTED BY THE MFR AND CONFIRMED A SOFTWARE FAILURE. PT WAS SENT TO A PLASTIC SURGEON FOR EVAL AND TREATMENT. INITIAL IMPRESSION IS THAT NO PERMANENT HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359808 LEICA OH5 MICROSCOPE EPT LEICA MICROSYSTEMS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other