BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA BIOSYSTEMS CYTOVISION GSL

    MDR report key: 18609706 · Received January 30, 2024

    Report

    Report Number
    1419341-2024-00001
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    January 4, 2024
    Report Date
    January 30, 2024
    Manufacturer
    LEICA BIOSYSTEMS
    Product Code
    NTH
    UDI-DI
    00849832003762
    PMA / PMN Number
    K042542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY REVIEW WAS COMPLETED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES ASSOCIATED WITH THIS SERIAL NUMBER. TRENDING ANALYSIS REPORTED NO (0) OTHER RELATED OCCURRENCES OF THIS ISSUE FOR THIS SERIAL NUMBER. THE CYTOVISION WAS CLEANED AND A NEW TRAY WAS LOADED INTO THE SYSTEM AND FUNCTIONED AS EXPECTED. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 04 JAN 2024 THE CUSTOMER HAS REPORTED THE GLUE FAILED ON THE MAGNENT IN THE TRAY, MATERIAL 23GSL902XXX001, WHICH RESULTED IN BREAKING FIVE (5) BONE MARROW SLIDES FOR ONE (1) PATIENT WHILE USING CYTOVISION, MATERIAL 23GSLXXXKFXUPG, SERIAL (B)(6). THERE WAS TISSUE LOSS. IT IS UNKNOWN IF RE-BIOPSY WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420010 LEICA BIOSYSTEMS CYTOVISION GSL CYTOVISION GSL NTH LEICA BIOSYSTEMS 00849832003762

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other