BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE-TEK VIP(R)6 VACUUM INFILTRATION PROCESSOR, 230 VAC, 50 HZ

    MDR report key: 9418591 · Received December 5, 2019

    Report

    Report Number
    2083544-2019-00004
    Event Type
    Injury
    Date Received
    December 5, 2019
    Date of Event
    November 5, 2019
    Report Date
    December 5, 2019
    Manufacturer
    SAKURA SEIKI CO., LTD.
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SFE 'S INVESTIGATION (REF. PMDR COMPLAINT 02.044.339) REVEALED THAT ALCOHOL (IPA) GRADIENTS WERE NOT ADEQUATE. THE CONCENTRATION OF IPA IN THE FIRST IPA STEP (CONTAINER 3 AND 4) INDICATED 22.5% AND 50.2% WHERE THEY SHOULD BE 70%, 73% AND 86.5% IN THE SECOND STEP (CONTAINER 5 AND 6) WHERE THEY SHOULD BE 96%, AND 92% AND 95% IN THE LAST STEP (CONTAINER 7 AND 8) WHERE THEY SHOULD BE 100%. OTHER REAGENTS LOADED IN THE SYSTEM, FORMALIN, WATER, XYLOL, PARAFFIN, XYLENE ETC., SHOW NO ABNORMALITIES AND WERE FOUND TO BE ADEQUATE. IT IS CONCLUDED THAT THE LOW IPA CONCENTRATIONS WERE THE CAUSE OF INCOMPLETE DEHYDRATION OF THE TISSUE SAMPLES. FURTHER, A LOG FILE ANALYSIS WAS PERFORMED BY SFE TECHNICAL SUPPORT ENGINEER; NO ABNORMALITIES WERE FOUND IN THE IMPACTED PROCESSING RUN ON (B)(6) 2019, (PROGRAM NAME: NAKTS, WITH START TIME: (B)(6) 2019 16:25). ACCORDING TO THE RECEIVED DATA FROM THE INSTRUMENT, THE SYSTEM OPERATED PROPERLY AND THE RUN COMPLETED AS NORMAL. NO INDICATIONS WERE FOUND FOR INCORRECT OPERATION OR OVERFLOW OF REAGENTS. BASED ON THIS, A RECOMMENDATION WAS MADE TO SITE TO CLEAN ALL IPA CONTAINERS AND REFILL THEM WITH FRESH IPA'S. OTHER RECOMMENDATIONS WERE ALSO MADE FOR OBTAINING OPTIMAL RESULTS FROM THE PROCESSING RUN.

    Description of Event or Problem · 1

    SAKURA FINETEK EUROPE (SFE) INFORMED SAKURA FINETEK USA, INC. (SFA) OF AN EVENT IN LATIVA WHICH OCCURRED ON (B)(6) 2019, AND WAS REPORTED TO SFE ON (B)(6) 2019, INVOLVING THE TISSUE-TEK VIP6 INSTRUMENT, SER# (B)(4). SITE STATED THAT TISSUES WHICH WERE PROCESSED ON VIP6 ON (B)(6) 2019, APPEARED BURNED AFTER H&E STAINING. A SECTION OF THE TISSUES HAD A CLOUDY APPEARANCE WITH THE NUCLEI VARYING IN STAINING PROPERTIES. THERE WAS NO CHROMATIN DEFINITION IN THE NUCLEI AND SOME NUCLEI APPEARED "WASHED OUT." AS A RESULT OF THIS ISSUE, 3 OUT OF 16 INVOLVED PATIENTS COULD NOT BE DIAGNOSED, REQUIRED RE-BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211580 TISSUE-TEK VIP(R)6 VACUUM INFILTRATION PROCESSOR, 230 VAC, 50 HZ VIP6 IEO SAKURA SEIKI CO., LTD. 6032

    Patients

    Seq Age Sex Outcome Treatment
    1 Other