BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE-TEK XPRESS(R) X120

    MDR report key: 12658050 · Received October 19, 2021

    Report

    Report Number
    2083544-2021-00002
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    September 21, 2021
    Report Date
    October 14, 2021
    Manufacturer
    SAKURA FINETEK USA, INC.
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD TECH. SERVICE (FTS) REPORTED THE REVIEW OF ERROR LOG FOR ANY RECENT ERRORS, TEST UNIT FUNCTION FOR ANY RECENT ERRORS THAT ARE IN LOG TO MAKE SURE THOSE FUNCTIONS ARE CURRENTLY OPERATING PROPERLY. IN OPERATOR MODE LOG ON AND ALLOW UNIT TO COMPLETE WARM-UP CYCLE, ENABLE "REAGENTS 3/4 " ICON WHEN READY. RUN TWO CONSECUTIVE BASKET HANDLES THROUGH UNIT IN OPERATOR PROGRAM, VERIFY PROGRAM COMPLETES WITHOUT ERROR IN APPROXIMATE COMPLETION TIME INDICATED ON SCREEN. IF UNIT DOES NOT COME OUT OF WARM UP CYCLE INSPECT HEATER FUNCTIONS IN SERVICE MODE OF ALL STATIONS TO SEE IF ANY HEATERS DO NOT REACH SET TEMPERATURE. FTS ADVISED THE CUSTOMER FROM HOLDING THESE BLOCKS IN A DRY EMBEDDING WELL. DRY HEAT WILL EXASPERATE ANY ARTIFACT THAT MAY COME FROM PROCESSOR MALFUNCTION. THE CUSTOMER PUT IN PLACE A POLICY TO NOT HAND DIP SPECIMENS ON THE X120. IN ADDITION, PREVENTIVE MAINTENANCE WAS DUE IN OCT. 2021 AND IT WAS PERFORMED; REFER TO PM (B)(4).

    Description of Event or Problem · 0

    SAKURA FINETEK WAS NOTIFIED OF AN INCIDENT ON 09/30/2021 WHICH OCCURRED ON (B)(6) 2021 WITH THE X120 INSTRUMENT, SERIAL NO. (B)(4). USER STATED THAT TWO BASKETS OF 40 BLOCKS OF PATIENT SPECIMENS (CONSISTS OF DERMATOLOGY BIOPSIES AND GI BIOPSIES) WERE LOADED ON THE INSTRUMENT AND IT WAS OBSERVED AFTER 30 MINUTES THAT UNIT STOPPED MOVEMENT. THE USER DECIDED TO REMOVE THE BASKETS TO MANUALLY PROCESS THEM BY USING THE RETORTS AND REAGENTS IN THE UNIT ACCORDING TO STATION TIMES OF 15 MINS EACH. THIS ELIMINATED THE BENEFIT OF MICROWAVE AND VACUUM IN THE RETORTS. ONCE THEY WERE COMPLETED BY HAND THE UNIT WAS SHUT DOWN MANUALLY LEFT TO REST FOR A FEW MINUTES THEN RESTARTED. AS A RESULT OF THIS, THE CELLULAR STRUCTURE OF ONE (1) SPECIMEN WAS NOT DISTINGUISHABLE AND TISSUE WAS UNDIAGNOSABLE AND A RE-BIOPSY WAS PERFORMED. THE DAMAGE WAS CAUSED BY USER NOT USING THE X120 PER THE MANUFACTURER'S INTENDED USE. THE X120 USES VACUUM AND MICROWAVE TECHNOLOGY FOR RAPID TISSUE PROCESSING. WHEN THE MECHANICAL ARM DID NOT MOVE, USER DECIDED TO MANUALLY HAND-PROCESS THE SPECIMENS BY TRANSFERRING THE BASKETS OF TISSUE CASSETTES FROM ONE REAGENT TO ANOTHER, WITH NO VACUUM/MICROWAVE CAUSING SUBOPTIMAL PROCESSING RESULTING IN TISSUE MORPHOLOGY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554680 TISSUE-TEK XPRESS(R) X120 X120 IEO SAKURA FINETEK USA, INC. 7720

    Patients

    Seq Age Sex Outcome Treatment
    1 Other