BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA RM2125

    MDR report key: 2281602 · Received September 30, 2011

    Report

    Report Number
    8010478-2011-00009
    Event Type
    Malfunction
    Date Received
    September 30, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 8, 2011
    Manufacturer
    LEICA BIOSYSTEMS, GMBH.
    Product Code
    IDL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INDICATED THE CAUSE FOR THE MALFUNCTION WAS DUE TO THE INCORRECT FUNCTIONING OF THE UNIVERSAL CASSETTE CLAMP. THE CASSETTES WHICH WERE USED WERE NOT PROPERLY HELD BY THE CLAMP. THE ANALYSIS OF THE AFFECTED CLAMP HAS BEEN SHOWN THAT ONE OF THE TWO SPRINGS IS BROKEN. THEREBY A STABLE TERMINAL OF THE CLAMP IS NO LONGER POSSIBLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHILE CUTTING WITH THE MICROTOME, THE UNIVERSAL CASSETTE CLAMP DID NOT HOLD THE BLOCKS TIGHTLY. THE TISSUE SAMPLES WERE PULLED OUT FROM THE EMBEDDING MATERIAL, HOWEVER, THEY WERE NOT DESTROYED AND COULD BE FURTHER PROCESSED AND WERE ABLE TO BE DIAGNOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEICA RM2125 MICROTOME IDL LEICA BIOSYSTEMS, GMBH. RM2125

    Patients

    Seq Age Sex Outcome Treatment
    1