BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 1932136 · Received December 7, 2010

    Report

    Report Number
    8020030-2010-00057
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 18, 2010
    Manufacturer
    VISION BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, METHOD: INVESTIGATION OF THIS PROCESSING EVENT BY LEICA MICROSYSTEMS IS CONTINUING.

    Description of Event or Problem · 1

    ON (B)(6) 2010, LEICA MICROSYSTEMS RECEIVED A COMPLAINT REGARDING UNDER-PROCESSED AND MUSHY TISSUE FROM A PROCESSING PROTOCOL(S) RUN ON PELORIS TISSUE PROCESSOR SERIAL NUMBER (B)(4), WHICH COMPLETED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELORIS RAPID TISSUE PROCESSOR TISSUE PROCESSOR IEO VISION BIOSYSTEMS MELBOURNE 26.0005

    Patients

    Seq Age Sex Outcome Treatment
    1