BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE-TEK AUTOSECTION(R) AUTOMATED MICROTOME

    MDR report key: 14988015 · Received July 12, 2022

    Report

    Report Number
    2083544-2022-00001
    Event Type
    Injury
    Date Received
    July 12, 2022
    Date of Event
    June 21, 2022
    Report Date
    June 21, 2022
    Manufacturer
    SAKURA FINETEK USA, INC.
    Product Code
    IDO
    UDI-DI
    00615233079350
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A USER ERROR BY SAKURA EMPLOYEE. EMPLOYEE DID NOT FOLLOW THE INSTRUCTION AS PER OPERATING MANUAL AND DID NOT ENSURE THE BLADE GUARD WAS IN PLACE BEFORE REMOVING THE CASSETTE.

    Description of Event or Problem · 0

    SAKURA FINETEK WAS NOTIFIED OF AN INCIDENT ON (B)(6) 2022 WHICH OCCURRED ON (B)(6) 2022 WITH THE AUTOSECTION INSTRUMENT, SERIAL NO. (B)(4). INCIDENT OCCURRED DURING INSTALLATION OF INSTRUMENT. WHILE SETTING UP THE AUTOSECTION INSTRUMENT, SAKURA FIELD APPLICATION SPECIALIST NOTICED THE BLOCKS THAT THE CLIENT USED WERE BIGGER THAN THE NORMAL CASSETTES USED; THEREFORE, SAKURA EMPLOYEE PUT ONE OF THE CLIENT'S CASSETTE IN THE UNIT TO ENSURE IT WOULD CLEAR THE BLADE HOLDER. EMPLOYEE PRESSED THE ALIGN BUTTON AND REALIZED HE DID NOT WANT TO CUT INTO THE CLIENT'S BLOCK, SO THE EMPLOYEE TRIED TO GRAB THE CASSETTE BEFORE THE UNIT STARTED. THE UNIT STARTED AND BROUGHT EMPLOYEE'S FINGER ON THE BLADE CAUSING A DEEP CUT ACROSS THE TIP OF EMPLOYEE'S LEFT THUMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772399 TISSUE-TEK AUTOSECTION(R) AUTOMATED MICROTOME AUTOSECTION IDO SAKURA FINETEK USA, INC. 5010 00615233079350

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R