BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS II

    MDR report key: 5836206 · Received July 27, 2016

    Report

    Report Number
    MW5063750
    Event Type
    Malfunction
    Date Received
    July 27, 2016
    Date of Event
    July 18, 2016
    Report Date
    July 27, 2016
    Manufacturer
    LEICA MICROSYSTEMS INC
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DUE TO THE TISSUE PROCESSOR MALFUNCTION IN HISTOLOGY LAB, THE BIOPSY WAS NOT PROCESSED APPROPRIATELY AND REQUIRED ADD'L BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480052 PELORIS II TISSUE PROCESSOR IEO LEICA MICROSYSTEMS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other