BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 1841200 · Received August 31, 2010

    Report

    Report Number
    8020030-2010-00019
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 31, 2010
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: LEICA'S INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    LEICA MICROSYSTEMS RECEIVED A COMPLAINT FROM THE CUSTOMER OF SUBOPTIMALLY PROCESSED TISSUE FROM A PELORIS TISSUE PROCESSOR. THE CUSTOMER ADVISED THAT THE AFFECTED TISSUE SAMPLES WOULD BE REPROCESSED.

    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