BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA M720 OH5 SAI

    MDR report key: 2024271 · Received March 10, 2011

    Report

    Report Number
    3003974370-2011-00008
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    July 3, 2010
    Report Date
    July 4, 2010
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2010, A HIGH-GRADE BRAIN STEM GLIOMA WAS CONDUCTED USING LEICA M720 OH5 SAI. THE SURGICAL PROCEDURE WENT WELL UNTIL THE VERY END, WHEN THE SURGEON REDUCED THE MICROSCOPE'S IRIS TO ITS SMALLEST DIAMETER. HE ATTEMPTED TO RE-OPEN THE IRIS WHEN IT REMAINED STUCK IN THAT POSITION. AFTER SEVERAL FAILED ATTEMPTS TO OPEN THE IRIS, THE SURGEON REMOVED THE SCOPE FROM THE FIELD, FINISHING THE CASE WITHOUT INCIDENT. A PERFORMANCE TEST WAS PERFORMED ON SITE BY THE DISTRIBUTOR'S REP. THE MICROSCOPE WAS UNDRAPED AND WAS RE-BOOTED TWICE WITHOUT CORRECTING THE PROBLEM. A COUPLE OF HOURS LATER, THE MICROSCOPE WAS RESTARTED AGAIN AND THE IRIS IMMEDIATELY RE-SET TO ITS FULL OPEN POSITION. THE IRIS WAS OPENED AND CLOSED SEVERAL TIMES AND REVEALED A DISTINCTIVE MECHANICAL SQUEAK/NOISE (METAL AGAINST METAL). THE OPTICS CARRIER WAS REPLACED AND THE AFFECTED OPTICS CARRIER WAS SENT TO THE MANUFACTURER. PERFORMANCE TEST WAS CONDUCTED BY THE MANUFACTURER. RESULTS SHOWED THAT THE IRIS WAS NOT ADJUSTED CORRECTLY. THE IRIS CAN CLOSE TOO MUCH, WHICH CAN CAUSE DAMAGE TO THE IRIS ITSELF. VISUAL EXAMINATION ALSO REVEALED THAT THE BLADES OF THE IRIS WERE DEFORMED. IN THE COMBINATION WITH HEAT, THEY CAN BLOCK THE OPENING OF THE IRIS. THIS MALFUNCTION IS CONSIDERED AS A SINGLE CASE, CAUSED BY WRONG ADJUSTMENT IN THE ASSEMBLY LINE. FROM JULY 2010 TO PRESENT, SIMILAR COMPLAINTS HAVE NOT BEEN REPORTED TO THE MANUFACTURER. THE INSTRUMENT IS IN ROUTINE USE.

    Description of Event or Problem · 1

    ON (B)(4) 2010, LEICA REC'D A COMPLAINT FROM AN INDEPENDENT MANUFACTURING REP STATING THAT DURING A SURGICAL PROCEDURE, THE IRIS OF LEICA M720 OH5 SAI REMAINED STUCK IN THE SMALLEST DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEICA M720 OH5 SAI SURGICAL MICROSCOPE EPT LEICA MICROSYSTEMS (SCHWEIZ) AG M720 OH5 SAI

    Patients

    Seq Age Sex Outcome Treatment
    1