BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR.

    MDR report key: 3240882 · Received July 17, 2013

    Report

    Report Number
    8020030-2013-00047
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 20, 2013
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT REGARDING SUB-OPTIMAL PROCESSING OF TISSUE IN APPROXIMATELY 400 CASSETTES, USING PELORIS 11 TISSUE PROCESSOR. THE COMPLAINANT ADVISED THAT THE AFFECTED TISSUE SAMPLES, WHICH WERE UNDER-PROCESSED AND REQUIRED RE-PROCESSING, COMPRISED FATTY, DERMATOLOGICAL, LARGE (COLON, BREAST) AND BONE MARROW SAMPLES. ON (B)(6) 2013, LEICA BIOSYSTEMS RECEIVED INFORMATION THAT ALL TISSUE SAMPLES EXHIBITING SUB-OPTIMAL TISSUE PROCESSING WERE DIAGNOSABLE. INVESTIGATION OF THIS COMPLAINT BY LEICA BIOSYSTEMS IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332412 PELORIS RAPID TISSUE PROCESSOR. TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1