BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS

    MDR report key: 5836205 · Received July 27, 2016

    Report

    Report Number
    MW5063749
    Event Type
    Malfunction
    Date Received
    July 27, 2016
    Date of Event
    July 11, 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

    THE UNIT DISPLACED ERROR CODE 1103- PRESSURE FAILURE DUE TO THE TISSUE PROCESSORS 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
    479975 PELORIS TISSUE PROCESSOR IEO LEICA MICROSYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other