BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE-TEK VIP 6

    MDR report key: 2822285 · Received May 29, 2012

    Report

    Report Number
    2083544-2012-00004
    Event Type
    Injury
    Date Received
    May 29, 2012
    Date of Event
    April 26, 2012
    Report Date
    May 29, 2012
    Manufacturer
    SAKURA FINETEK USA, INC.
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO ROOT CAUSE COULD BE DETERMINED. HOWEVER, THE SPECIMENS LIKELY COULD HAVE BEEN SALVAGED IF REPROCESSED IN ACCORDANCE WITH (SHEEHAN, D. AND HRAPCHAK, B. (1987) THEORY AND PRACTICE OF HISTOTECHNOLOGY, BATTELLE PRESS).

    Description of Event or Problem · 1

    A TECH AT THE LAB INDICATED THAT THREE (3) TISSUES OUT OF 133 PROCESSED ON THE SAKURA VIP 6 INSTRUMENT WERE NOT PROCESSED ADEQUATELY. THE LAB REPROCESSED TISSUES BY PLACING THEM IN A WARMING TRAY, TO MELTOFF EXCESS PARAFFIN ON THE EXTERIOR OF THE TISSUE AND THEN RUNNING THEM ON THE PROCESSOR AGAIN. THE REPROCESSING USING THESE STEPS WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TISSUE-TEK VIP 6 TISSUE PROCESSOR IEO SAKURA FINETEK USA, INC. 6030

    Patients

    Seq Age Sex Outcome Treatment
    1 Other