BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 2070572 · Received March 30, 2011

    Report

    Report Number
    8020030-2011-00020
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS COMPLAINT BY LEICA MICROSYSTEMS IS CONTINUING.

    Description of Event or Problem · 1

    ON (B)(6) 2011, LEICA MICROSYSTEMS RECEIVED A COMPLAINT FROM (B)(6) CENTER REGARDING SUB-OPTIMAL TISSUE PROCESSING FROM A PROTOCOL(S) RUN USING A PELORIS TISSUE PROCESSOR SERIAL NUMBER (B)(4). ON (B)(6) 2011, LEICA MICROSYSTEMS RECEIVED INFORMATION THAT ALL THE TISSUE SAMPLES FROM THE PROTOCOL(S) EXHIBITING SUB-OPTIMAL PROCESSING WERE ABLE TO BE REPORTED. PATIENT RE-BIOPSY WAS NOT REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1