BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE-TEK AUTOSECTION(R) AUTOMATED MICROTOME

    MDR report key: 12140290 · Received July 8, 2021

    Report

    Report Number
    2083544-2021-00001
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    June 10, 2021
    Report Date
    July 8, 2021
    Manufacturer
    SAKURA FINETEK USA, INC.
    Product Code
    IDO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE LOG FILES BY SAKURA TECHNICAL ENGINEER REVEALED NO ABNORMALITIES WITH THE INSTRUMENT. THE LOG FILES INDICATED THAT THE LAB TECHNICIAN PRESSED THE ALIGN/SECTION AND SECTION BUTTONS TO START SECTIONING OF THE BLOCK, GOT HURT AND PRESSED THE REMOTE STOP BUTTON AND THE FOOT PEDAL TO STOP THE AUTOSECTION. THE EMO-BUTTON OR EMERGENCY STOP BUTTON WAS NOT UTILIZED, WHICH WOULD HAVE IMMEDIATELY STOPPED THE MOVEMENT OF THE CHUCK AND PREVENTED THIS TYPE OF INJURY. THE SUBJECT AUTOSECTION INSTRUMENT WAS INSTALLED ON (B)(6) 2021. THE LAB HAD EXPERIENCE WITH MICROTOMES. THE SAKURA APPLICATION SPECIALIST TRAINED THE LAB STAFF AFTER THE INSTALLATION OF THE AUTOSECTION. THE USER INVOLVED IN THIS INCIDENT STARTED WORKING AT THE LAB ON (B)(6) 2021, WAS TRAINED INTERNALLY. HE STATED THAT HE KNEW HOW TO STOP THE INSTRUMENT WITH THE EMERGENCY STOP BUTTON, BUT IN THAT MOMENT, USED HIS HANDS IN ATTEMPT TO STOP THE CHUCK. SAKURA FINETEK EUROPE IS IN CONTACT WITH THE LAB TO DISCUSS WHETHER ADDITIONAL TRAINING IS NEEDED. BASED ON THE ABOVE, THIS INCIDENT IS CONSIDERED TO BE USER RELATED AND NOT A DEVICE MALFUNCTION. MICROTOME BLADES ARE EXTREMELY SHARP AND INHERENTLY DANGEROUS. INATTENTION TO THE TASK AT HAND AND FAILURE TO UTILIZE SAFETY DEVICES CAN CAUSE A SERIOUS INJURY. THE AUTOSECTION INSTRUMENT IS EQUIPPED WITH A RED COLORED BLADE GUARD AND AUDIO/VISUAL ALERT AS A SAFETY DEVICE TO PROTECT THE USER FROM ACCIDENTAL EXPOSURE TO THE BLADE EDGE AND INJURY WHEN USED PROPERLY. THIS MEANS THE SAFETY LIGHTING WILL CHANGE COLOR (FROM RED TO WHITE) AND A CLICK WILL BE AUDIBLE INDICATING THE CHUCK IS INTO PLACE AND STOPPED. THE OPERATING MANUAL OF THE AUTOSECTION, SEC 1.4.1 WARNINGS AND 4.6 ROUTINE OPERATION - WARNINGS, CLEARLY STATES THAT USER MUST "ALWAYS LOCK THE HAND WHEEL AND COVER THE CUTTING EDGE WITH THE BLADE GUARD PRIOR TO MANIPULATING THE BLADE OR THE SPECIMEN, CHANGING THE SPECIMEN, OR WHEN THE INSTRUMENT IS NOT IN USE." THE INSTRUMENT DID NOT MALFUNCTION OR CAUSE THIS INJURY; IT FUNCTIONED AS INTENDED ACCORDING TO THE SPECIFICATIONS AND IS SAFE TO USE.

    Description of Event or Problem · 1

    SAKURA FINETEK (B)(6) WAS NOTIFIED OF AN INCIDENT ON (B)(6) 2021, WHICH OCCURRED IN (B)(6) ON (B)(6) 2021 WITH THE TISSUE-TEK AUTOSECTION AUTOMATED MICROTOME INSTRUMENT, SER# (B)(4). USER STATED THAT THE INSTRUMENT WAS SET TO AN AUTOMATIC MODE AND WHILE TRIMMING A BLOCK, HE DISCOVERED THAT THE BLOCK WAS NOT PLACED CORRECTLY IN THE MICROTOME CHUCK WHEN HE PRESSED THE ALIGN/FACE BUTTON AND TRIED TO STOP THE CHUCK WITH HIS HAND, WHICH CAUSED SEVERAL CUTS IN HIS HAND WITH THE BLADE. THIS INJURY REQUIRED 20 STITCHES AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036588 TISSUE-TEK AUTOSECTION(R) AUTOMATED MICROTOME AUTOSECTION IDO SAKURA FINETEK USA, INC. 5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other