BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOS - REM - RAPID MICROWAVE HISTOPROCESSOR

    MDR report key: 2351579 · Received November 17, 2011

    Report

    Report Number
    1000391282-2010-00001
    Event Type
    Malfunction
    Date Received
    November 17, 2011
    Date of Event
    July 27, 2010
    Report Date
    August 23, 2010
    Manufacturer
    MILESTONE S.R.L.
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT RETURNED TO MFR, BUT THE MFR IS ABLE TO PERFORM TESTS IN THE SAME CONDITION USING THE OSMIUM COATED SPINDLE. THE TEST SHOWS THAT USING OSMIUM COATED SPINDLE THE ARCING CONTINUED TO OCCUR BUT NOT USING A NEW (NON-COATED OSMIUM) SPINDLE THE ARCING. THE UNIT ITSELF FUNCTIONED AS DESIGNED. EVALUATION RESULTS: THE COLUMN OF THE RACK SUPPORT WAS COVERED BY OSMIUM AND DURING THE EMISSION OF THE MICROWAVE ENERGY THERE ARE THE PRESENCE OF ARC DURING THE NON-POLAR TOLUENE REAGENT STEP. THE ARC AT HIGH ENERGY DAMAGED SPINDLE AND CASSETTE UNIT. MILESTONE HAS IDENTIFIED THE POTENTIAL ROOT CAUSE (ARCING OF MICROWAVE DURING NON-POLAR REAGENT STEP DUE TO OSMIUM BUILD-UP ON EXPOSED SPINDLE COMPONENT CREATING THE PRESENCE OF A REFLECTION ANGLE), BUT FURTHER TESTING IS REQUIRED TO CONFIRM ROOT CAUSE AND POTENTIAL CORRECTIVE ACTIONS. MILESTONE WILL SUBMIT A F/U REPORT, IF REQUIRED, ONCE ADD'L DATA IS AVAILABLE.

    Description of Event or Problem · 1

    THE HISTOS REM UNIT (MICROWAVE HISTOPROCESSOR) WAS PROCESSING IN TOLUENE STEP. A LAB TECH DETECTED A BURNING PLASTIC ODOR COMING FROM THE PROCESSOR. HE IMMEDIATELY TERMINATED THE PROGRAMMED STEP AND TURNED OFF THE UNIT. THE PLASTIC VIAL (HOLDING THE SPECIMEN BASKETS) WAS PARTIALLY MELTED AND THE SOLVENT (TOLUENE) IN THE VIAL WAS DISCOLORED. SOME OF THE SOLVENT WAS FORCED OUT OF THE VIAL INTO THE SURROUNDING MICROWAVE CHAMBER. NORMALLY, TOLUENE WOULD REMAIN COLOURLESS AFTER THIS STEP. ALSO, THE SPECIMEN BASKETS CONTAINED WITHIN THE VIAL WERE PARTIALLY MELTED/DISTORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HISTOS - REM - RAPID MICROWAVE HISTOPROCESSOR TISSUE PROCESSOR IEO MILESTONE S.R.L. HISTOS-REM

    Patients

    Seq Age Sex Outcome Treatment
    1