BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE-TEK AUTOTEC® A120 AUTOMATED EMBEDDING SYSTEM

    MDR report key: 17981196 · Received October 20, 2023

    Report

    Report Number
    2083544-2023-00007
    Event Type
    Injury
    Date Received
    October 20, 2023
    Date of Event
    October 3, 2023
    Report Date
    October 20, 2023
    Manufacturer
    SAKURA SEIKI CO., LTD.
    Product Code
    IEO
    UDI-DI
    04946433600362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SAKURA FIELD TECHNICAL SUPPORT (FTS) CONFIRMS THE UNIT WAS FUNCTIONING AS INTENDED. THIS IS A USER ISSUE OF NOT ASSEMBLING THE PARAFORM CASSETTES AS INSTRUCTED. WHILE ON THE A120 BEING EMBEDDED, IF THE LID IS NOT CLOSED CORRECTLY, IT CAN POSSIBLY CATCH ON THE CASSETTE ABOVE IT AND CAUSE THE LID TO COME OPEN WHEN THE GRIPPER GRABS IT AND PULLS IT OUT. BUT WHEN IT SCANS THE CASSETTE, IT SHOULD RECOGNIZE THAT THE LID ISN'T CLOSED CORRECTLY AND REJECT THE CASSETTE. NO CORRECTIVE ACTION REQUIRED ON THE INSTRUMENT BECAUSE TISSUE-TEK AUTOTEC A120 DID NOT MALFUNCTION AND IS WORKING WITHIN SPECIFICATION. THE CUSTOMER OPERATING THE INSTRUMENT DID NOT PROPERLY CLOSE THE CASSETTE LIDS CAUSING THE TISSUE LOSS IN THE INSTRUMENT. CORRECTIVE ACTION FOR THE CUSTOMER IS TO ALWAYS HAVE A TRAINED PROFESSIONAL USER WORKING ON THE INSTRUMENT AND PROPERLY CLOSE CASSETTE LIDS PRIOR TO LOADING ON THE INSTRUMENT.

    Description of Event or Problem · 0

    ON (B)(6) 2023 A CUSTOMER REPORTED TO SAKURA FIELD TECHNICAL SUPPORT (FTS) AGENT THAT A CASSETTE CAME OUT OF THE TISSUE-TEK AUTOTEC A120 INSTRUMENT WITHOUT A LID WHICH CAUSED A TISSUE LOSS. BECAUSE IT APPEARED THE LID WAS OFF PRIOR TO THE CASSETTE GETTING TO ACTUAL EMBEDDING, THE INSTRUMENT DIDN'T ERROR FOR A LOOSE LID. DUE TO THE TISSUE LOSS, A PATIENT WILL HAVE TO UNDERGO A RE-BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120939 TISSUE-TEK AUTOTEC® A120 AUTOMATED EMBEDDING SYSTEM AUTOTEC A120 IEO SAKURA SEIKI CO., LTD. 7090 04946433600362

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Congenital Anomaly| O