BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA M525 F40

    MDR report key: 1945265 · Received December 21, 2010

    Report

    Report Number
    3003974370-2010-00008
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON HAD PLANNED TO USE HIS NORMAL MICROSCOPE BUT THAT INSTRUMENT WAS NOT WORKING, SO THE LEICA M525 F40 WAS BROUGHT INTO THE ROOM. HE WAS UNFAMILIAR WITH THE INSTRUMENT. THE INSTRUMENT WAS USED WITH THE 300 WATT XENON LIGHT AT FULL POWER AND AT A SHORT DISTANCE. LOBAN TYPE COVERING WAS NOT USED. ONCE THE MICROSCOPE CAME OUT OF THE FIELD, THE DOCTOR NOTICED A BLISTER ON THE PT'S EAR. A PERFORMANCE TEST WAS CONDUCTED BY THE MFR. ACCORDING TO THE RESULTS, THE 2.5 YEAR OLD INSTRUMENT IS FUNCTIONING PROPERLY, APPEARS TO BE WELL MAINTAINED AND NO EXTERNAL DAMAGE WAS OBSERVED. AN OUTPUT OF 74% OF THE XENON LIGHT'S MAXIMUM OUTPUT AT 207 MM WAS MEASURED. THE HALOGEN LAMP WAS MEASURED AND IS WITHIN SPECIFICATIONS. THE LEICA M525 F40 IS SUBJECT TO SPECIAL PRECAUTIONARY MEASURES AS DESCRIBED IN THE USER MANUAL. BEFORE USING THE PRODUCT, THE USER MUST CAREFULLY AND THOROUGHLY READ THE USER MANUAL. THE USER MANUAL ALSO CONTAINS IMPORTANT INFO ON ILLUMINATION (PAGE 8), SAFETY NOTES, WARNINGS, AS WELL AS INFORMATION ON USING THE INSTRUMENT. A WARNING ON TISSUE HEATING HAS BEEN INCLUDED IN THE USER MANUAL (PAGE 8) AS A SAFETY PRECAUTION FOR THE USER AND PT. IN ADDITION, A WARNING LABEL IS ALSO ATTACHED ON THE DEVICE AND WAS VERIFIED AS BEING IN PLACE AND CLEARLY VISIBLE ON THE DEVICE. AS OF (B)(6) 2010, THE PT IS DOING FINE, WILL NOT REQUIRE FURTHER MEDICAL INTERVENTION AND IS EXPECTED TO FULLY RECOVER FROM THE MINOR INJURY. THE INSTRUMENT REMAINS IN ROUTINE USE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, LEICA MICROSYSTEMS RECEIVED A COMPLAINT FROM A CUSTOMER STATING THAT DURING A SURGICAL PROCEDURE, A (B)(6) PT RECEIVED A BURN BLISTER ON THE PINNA AREA OF THE EAR AFTER THE PT HAD UNDERGONE A PRESSURE EQUALIZING TUBE INSERTION. THE TUBE INSERTION TOOK APPROX 10 MINS AND WAS PERFORMED WITH A LEICA M525 F40 MICROSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEICA M525 F40 SURGICAL MICROSCOPE EPT LEICA MICROSYSTEMS (SCHWEIZ) AG M525 F40

    Patients

    Seq Age Sex Outcome Treatment
    1 19 MO