BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IP ROUTINE VI, TAPED WHITE 1000

    MDR report key: 4597772 · Received March 6, 2015

    Report

    Report Number
    1419341-2015-00001
    Event Type
    Malfunction
    Date Received
    March 6, 2015
    Date of Event
    February 4, 2015
    Report Date
    February 4, 2015
    Manufacturer
    LEICA BIOSYSTEM SRICHMOND, INC.
    Product Code
    IEO
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER HAS REQUESTED PRODUCT SAMPLES FROM CUSTOMER FOR EVALUATION. FOLLOW UP REPORT WILL BE SENT ONCE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO LEICA ON 02/0/2015 THAT DURING PROCESSING, THERE WERE CASSETTES THAT OPENED AND TISSUE WAS LOST WITHIN THE PROCESSOR. CUSTOMER WAS ABLE TO PROCEED DUE TO HAVING SUFFICIENT TISSUE SAMPLES THAT WERE SUCCESSFULLY PROCESSED DURING THE RUN FOR EACH PT. NO PT RE-BIOPSY WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156502 IP ROUTINE VI, TAPED WHITE 1000 TISSUE PROCESSING CASSETTES IEO LEICA BIOSYSTEM SRICHMOND, INC. 39LC-550-1-L A20140920C11, 917C11

    Patients

    Seq Age Sex Outcome Treatment
    1 Other