BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 1063457 · Received June 20, 2008

    Report

    Report Number
    8020030-2008-00007
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 19, 2008
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION FROM INVESTIGATION: MOST LIKELY CAUSE OF TISSUE BEING COMPROMISED IS BELIEVED TO BE DUE TO; SMALL PARTICULATE CONTAMINATION: SMALL PARTICULATE CONTAMINATION IS HARD TO DETECT AND CAN OCCUR DUE TO A NUMBER OF REASONS, SOME BEING; WHEN FILLING THE INSTRUMENT WITH WAX OR CHEMICALS PARTICULATE CONTAMINATION CAN BE INTRODUCED. CONTAMINANTS CAN ORIGINATE FROM THE CHEMICALS OR BE INTRODUCED TO THE CHEMICALS DURING FILLING. RETORT CLEANING - IF ADEQUATE CARE IS NOT TAKEN WHEN REMOVING THE FILTERS TO CLEAN THE RETORTS, PARTICLES FROM THE RETORT CAN FALL INTO THE SYSTEM. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SOME OF THE TISSUE SAMPLES PROCESSED IN 2008 WERE ADVERSELY AFFECTED BY THE INSTRUMENT RENDERING IT UNDIAGNOSABLE AND REQUIRING 3 TO 4 PTS TO BE DIAGNOSED BY ALTERNATE METHODS. ONCE ON SITE CUSTOMER ALSO RECALLED THAT ONE PT SAMPLE IN 2007 WAS POORLY PROCESSED AND WAS UNABLE TO BE USED FOR DIAGNOSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other