BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 1932166 · Received December 7, 2010

    Report

    Report Number
    8020030-2010-00054
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Report Date
    November 11, 2010
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ADD'L DEVICE MANUFACTURE DATE: 09/01/2009. EVAL, METHOD: INVESTIGATION OF THIS COMPLAINT BY LEICA MICROSYSTEMS IS CONTINUING.

    Description of Event or Problem · 1

    ON (B)(6) 2010, LEICA MICROSYSTEMS RECEIVED A COMPLAINT FROM (B)(6) MEDICAL CENTER REGARDING TISSUE THAT WAS DIFFICULT TO CUT OVER A THREE WEEK PERIOD, FOLLOWING PROCESSING USING THREE (3) PELORIS TISSUE PROCESSORS (B)(4). SPECIFIC DATE ON WHICH THE SUB-OPTIMAL PROCESSING OCCURRED WERE NOT PROVIDED.

    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