BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA M525 F20

    MDR report key: 3822903 · Received February 18, 2014

    Report

    Report Number
    3003974370-2014-00002
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    November 20, 2013
    Report Date
    November 20, 2013
    Manufacturer
    LEICA MICROSYSTEMS ( SCHWEIZ) AG
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFFECTED DEVICE IS IN EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    ON (B)(4) 2013, LEICA MICROSYSTEMS RECEIVED A COMPLAINT STATING THAT THE ILLUMINATION OF LEICA M525 F20 SURGICAL MICROSCOPE MALFUNCTIONED DURING A SURGICAL PROCEDURE (MASTOIDECTOMY SURGERY). BOTH LAMPS WERE NOT IN FULL INTENSITY AND THE FILTER WAS NOT IN THE CORRECT POSITION. THE ILLUMINATION (BOTH MODULES) SWITCHED ON AND OFF INTERMITTENTLY DURING THE MIDDLE OF THE SURGERY. THE MICROSCOPE WAS REPLACED DURING THE SURGERY TO CONTINUE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100865 LEICA M525 F20 MICROSCOPE, SURGICAL EPT LEICA MICROSYSTEMS ( SCHWEIZ) AG M525 F20

    Patients

    Seq Age Sex Outcome Treatment
    1