BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE-TEK® VIP® 6 AI VACUUM INFILTRATION PROCESSOR; 230 VAC, 50/60 HZ, 6 A

    MDR report key: 20098785 · Received August 29, 2024

    Report

    Report Number
    2083544-2024-00011
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    July 7, 2024
    Report Date
    August 27, 2024
    Manufacturer
    SAKURA SEIKI CO., LTD.
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SAKURA FINETEK EUROPE MENTIONED THAT BASED ON THEIR CONVERSATIONS WITH THE CUSTOMER AND LOCAL SAKURA SUPPORT IT HAS BEEN REPORTED THAT THE CUSTOMER'S LAB USES ONE PROGRAM FOR ALL TISSUE SAMPLES. SMALLER TISSUES SUCH AS BIOPSIES AND NEEDLE CORES HAVE NOT BEEN REPORTED TO BE AFFECTED, ONLY LARGER SAMPLES SUCH AS GALL BLADDER AND COLON HAVE BEEN NOTICED TO BE AFFECTED. IT WAS ALSO REPORTED NOT ALL BLOCKS IN ONE CASE WERE AFFECTED. IT IS UNCLEAR WHAT THE EXACT FIXATION TIMES OF THE AFFECTED CASES WERE. BASED ON THE CUSTOMER'S CONVERSATIONS, IN GENERAL SAMPLES ARE TAKEN ON DAY ONE AND FIXED FOR 24 HOURS PRIOR TO DISSECTION AND PROCESSING. MICROTOMY REPORTED NO ISSUES WHEN CUTTING THE CASES, NO CHEMICAL SMELL FROM THE BLOCKS WAS NOTICED. CUSTOMER ALSO MENTIONED THAT THEY DON'T USE A HOT PLATE TO DRY SLIDES. SLIDES ARE PLACED VERTICALLY IN LEICA RACKS AND DRIED IN STAINER OVEN. ON (B)(6) 2024, THE LOCAL FIELD SERVICE ENGINEER VISITED THE CUSTOMER IN IRELAND TO CHECK THE INSTRUMENT. NO MECHANICAL FAULTS WERE DETECTED, AND NO ERRORS WERE LISTED IN THE ERROR LOG. ON THE DATE OF THIS REPORT, THERE IS NOT ENOUGH INFORMATION AVAILABLE YET TO EXCLUDE THE INSTRUMENT FROM (POTENTIALLY) HAVING CONTRIBUTED TO THE SERIOUS INCIDENT. MORE INFORMATION IS BEING GATHERED BY LOCAL SAKURA SUPPORT AND LOGFILES WILL BE TAKEN FROM THE INSTRUMENT FOR ANALYSIS TO CONTINUE THE INVESTIGATION.

    Description of Event or Problem · 0

    SAKURA FINETEK EUROPE NOTIFIED SAKURA FINETEK USA ON 02- AUG-2024 ABOUT THE INCIDENT THAT OCCURRED BETWEEN (B)(6) 2024 AND (B)(6) 2024, SFE'S LOCAL SAKURA SUPPORT WAS CONTACTED BY THE CUSTOMER IN IRELAND WHO REPORTED THAT A FEW LARGER SAMPLES HAVE SHOWN POOR PROCESSING AND "BURN ARTIFACT", SIMILAR TO CAUTERISATION ARTIFACT WHILE USING TISSUE-TEK® VIP® 6 AI VACUUM INFILTRATION PROCESSOR. SAKURA FINETEK EUROPE ON BECOMING AWARE OF THE INCIDENT ON 26-JUL-2024, WERE INFORMED BY THE CUSTOMER THAT THE ISSUE OF COMPROMISED TISSUE QUALITY MAY HAVE STARTED A FEW WEEKS OR A MONTH AGO BEFORE THE ISSUE WAS REPORTED TO SAKURA FINETEK EUROPE. THE CUSTOMER ALSO MENTIONED THAT THE ISSUE OF POOR PROCESSING IS NOT CONSISTENT WITH EVERY RUN AND NOT ALL BLOCKS ARE IMPACTED. AND THAT THE CUSTOMER ALSO BECAME AWARE OF THE ISSUE BY THE PATHOLOGIST ON THE SAME DAY THEY REPORTED THE INCIDENT TO SAKURA FINETEK EUROPE (B)(6) 2024. PER CUSTOMER, THE TISSUE-TEK® VIP® 6 AI VACUUM INFILTRATION PROCESSOR HAS BEEN FUNCTIONING AS INTENDED AND NO ERRORS HAVE BEEN DISPLAYED ON THE INSTRUMENT DURING PROCESSING. TOTAL TISSUE AND PATIENT IMPACT ARE UNKNOWN AND ON THE DAY OF THE REPORT, ONE CASE HAS BEEN DECLARED AS "UNABLE TO ASSESS TUMOUR DEPTH" IN A COLON RESECTION CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355642 TISSUE-TEK® VIP® 6 AI VACUUM INFILTRATION PROCESSOR; 230 VAC, 50/60 HZ, 6 A VIP6 AI IEO SAKURA SEIKI CO., LTD. 6042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other