BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 1882674 · Received October 15, 2010

    Report

    Report Number
    8020030-2010-00034
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 18, 2010
    Report Date
    September 22, 2010
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: LEICA'S ON SITE INVESTIGATION COULD NOT FIND ANY INSTRUMENT FAULT THAT COULD HAVE CONTRIBUTED TO THE EVENT. LEICA'S REVIEW OF THE INSTRUMENT LOGS INDICATES THAT THE USER RESET BOTTLE 11 AS PURE BUT THEY DID NOT CHANGE THE CONTENT OF THE BOTTLE. THE IPA CONCENTRATION IN THE BOTTLE WAS LESS THAN 92% AND THIS WOULD HAVE RE-INTRODUCED ETHANOL AND WATER BACK INTO THE PROCESSING AND DAMAGED THE TISSUE. THE CUSTOMER CONFIRMED THAT ALL TISSUE SAMPLES WERE DIAGNOSED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO LEICA MICROSYSTEMS OF BRITTLE AND BURNT TISSUE FOLLOWING PROCESSING ON A PELORIS TISSUE PROCESSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELORIS RAPID TISSUE PROCESSOR TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PELORIS NA

    Patients

    Seq Age Sex Outcome Treatment
    1