BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 1930586 · Received December 1, 2010

    Report

    Report Number
    8020030-2010-00056
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 12, 2010
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE INSTRUMENT LOGS BY LEICA MICROSYSTEMS TO DETERMINE THE ROOT CAUSE OF THIS EVENT IS CONTINUING.

    Description of Event or Problem · 1

    ON (B)(6) 2010, LEICA MICROSYSTEMS REC'D A COMPLAINT FROM BAY AREA DERMATOPATHOLOGY OF VERY DRY AND BRITTLE TISSUE FROM A TISSUE PROCESSING PROTOCOL RUN ON (B)(6) 2010 USING PELORIS TISSUE PROCESSOR SERIAL NUMBER (B)(4), WHICH RESULTED IN THREE (3) PTS REQUIRING RE-BIOPSY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention