BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE-TEK AUTOSECTION(R) AUTOMATED MICROTOME

    MDR report key: 17390475 · Received July 25, 2023

    Report

    Report Number
    2083544-2023-00004
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    April 3, 2023
    Report Date
    July 19, 2023
    Manufacturer
    SAKURA FINETEK USA, INC.
    Product Code
    IDO
    UDI-DI
    00615233079350
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE PM BY THIRD PARTY SERVICE PROVIDER, THE ONLY ISSUE ENCOUNTERED IS THE TOUCHSCREEN OFTEN REGISTERS EACH TOUCH TWICE. IT IS UNKNOWN IF THIS COULD RESULT IN THE HEAD MOVING IF ACCIDENTALLY BRUSHED AGAINST, BUT DID NOT FIND ANY OTHER ISSUES WITH THE UNIT.

    Description of Event or Problem · 0

    SAKURA FINETEK THIRD PARTY SERVICE PROVIDER WAS DISPATCHED TO A CUSTOMER SITE ON 7/12/2023 TO PERFORM THE PREVENTIVE MAINTENANCE ON TISSUE-TEK AUTOSECTION SERIAL# (B)(6). THE CUSTOMER INFORMED THEM THAT APPROXIMATELY 3-4 MONTHS AGO, WHILE WORKING WITH THE BLADE HOLDER OF TISSUE-TEK AUTOSECTION, THE MICROTOME ACTIVATED AND THE HEAD DROPPED, RESULTING IN CUSTOMER RECEIVING 5 STITCHES ON THUMB. THE INCIDENT OCCURRED ON (B)(6) 2023 BUT WAS REPORTED TO SAKURA FINETEK ON 07/13/2023 BY THE THIRD PARTY SERVICE PROVIDER. THE CUSTOMER DID NOT CONSIDER REPORTING THIS TO SAKURA AT THE TIME AND CONTINUED USING THE INSTRUMENT WITHOUT FURTHER INCIDENT AND NO CAUSE WAS DETERMINED OF HOW THIS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335570 TISSUE-TEK AUTOSECTION(R) AUTOMATED MICROTOME AUTOSECTION IDO SAKURA FINETEK USA, INC. 5010 00615233079350

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other