BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA M820 F2C

    MDR report key: 2231633 · Received August 24, 2011

    Report

    Report Number
    3003974370-2011-00018
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 23, 2011
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4). WHEN THE SURGEON STARTED THE SURGICAL PROCEDURE, THE LIGHT OF THE MICROSCOPE BEGAN BLINKING AND THE FOCUS WAS GOING IN AND OUT. THE SURGEON MOVED THE MICROSCOPE UP AND DOWN TO RESET AND BEGAN AGAIN WITH THE SAME RESULT WITHIN 30 SECONDS OF STARTING. THE LIGHT GOES OFF/ON AND THE MICROSCOPE LOSES FOCUS. THE MICROSCOPE WAS POWERED ON AND OFF TO RESET AGAIN. HOWEVER, THE SAME RESULT WAS OBTAINED (LIGHT GOES OFF/ON AND THE MICROSCOPE LOSES FOCUS). AN ALTERNATE MICROSCOPE WAS BROUGHT IN TO FINISH THE PROCEDURE. NO PATIENT ADVERSE EVENT OCCURRED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP MICROSCOPE. THE NURSE INFORMED THE MANUFACTURER'S REPRESENTATIVE ABOUT THE MALFUNCTION AND ACCORDING TO THE NURSE, THE MICROSCOPE HAS "FOCUS AND CALIBRATION TROUBLE SINCE IT WAS DELIVERED." ON (B)(6) 2011, THE FIELD SERVICE ENGINEER REPAIRED THE MICROSCOPE. ACCORDING TO THE SERVICE REPORT, THE RESET SWITCH AND CONTROL UNIT WERE DEFECTIVE. THE DEFECTIVE PARTS WERE REPLACED AND THE SYSTEM WAS TESTED, CALIBRATED AND PASSED ALL PRIMARY TESTING. THE DEFECTIVE PARTS HAVE BEEN REQUESTED TO BE RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. ONCE THE RESULTS ARE OBTAINED, A FOLLOW-UP FORM FDA 3500A WILL BE SUBMITTED TO PROVIDE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, LEICA MICROSYSTEMS RECEIVED A COMPLAINT STATING THAT THE SURGICAL MICROSCOPE'S LAMP INTERMITTENTLY SHUTS OFF AS WELL AS FOCUS RESETS TO ITS HOME POSITION WHILE THE MICROSCOPE IS IN NORMAL PATIENT WORKING POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEICA M820 F2C SURGICAL MICROSCOPE EPT LEICA MICROSYSTEMS (SCHWEIZ) AG M820 F2C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other