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: 19736034 · Received July 12, 2024

    Report

    Report Number
    2083544-2024-00009
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    May 7, 2024
    Report Date
    July 12, 2024
    Manufacturer
    SAKURA SEIKI CO., LTD.
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER SAKURA FINETEK EUROPE, DETAILED LOG FILES OF THE INSTRUMENT WERE NOT AVAILABLE ANYMORE DUE TO THE DELAY IN DISCOVERING THE ISSUE VERSUS THE TIME THE LOGS HAVE BEEN TAKEN, THEREFORE ONLY THE REPORT FILES CAN BE REVIEWED FOR THE PURPOSE OF THIS INVESTIGATION. THE REPORT FILES SHOW NO ISSUES OR ERRORS ON THE DEVICE AND THE INSTRUMENT APPEARS TO PERFORM ACCORDING TO MANUFACTURERS SPECIFICATIONS. ACCORDING TO THE ERP LOGFILE, THE BULK REAGENTS (XYLENE AND ALCOHOL) WERE FILLED FROM EXTERNAL ON (B)(6) 2024. THESE REAGENTS WERE THEN USED ON (B)(6) 2024 TO FILL THE CLEANING REAGENTS AND DURING THE AUTOMATIC TRANSFER (AS EXECUTED ACCORDING TO THE ERP-FILE). THE ERP-FILE DOES NOT INDICATE THE USE OF THE BULK REAGENTS DURING TISSUE PROCESSING IN THAT TIME FRAME. BASED ON THE INFORMATION AVAILABLE IT MAY BE ASSUMED THE BULKS HAVE BEEN FILLED FAULTY, LEADING TO A REAGENT MIX-UP. IT IS TO BE NOTED THAT THE BULKS WERE EMPTIED AND REFILLED ON (B)(6) 2024. CUSTOMER CONFIRMED TO ALSO HAVE REPLACED ALL THE OTHER REAGENTS AND DID A FULL REAGENT EXCHANGE BY MANUAL PROCESS. BECAUSE OF THIS, THE LOCAL CUSTOMER SUPPORT TEAM WAS UNABLE TO SAMPLE THE REAGENTS USED DURING THE AFFECTED RUN FOR MEASURING AND PROVIDE POSSIBLE ROOT CAUSE. THE DEVICE HAS BEEN INSPECTED BY SAKURA FINETEK EUROPE'S LOCAL CUSTOMER SUPPORT. INVESTIGATIONS ARE ONGOING FOR POSSIBLE USE ERROR. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    SAKURA FINETEK EUROPE NOTIFIED SAKUTA FINETEK USA ON (B)(6) 2024 ABOUT THE INCIDENT THAT OCCURED SOMETIME BETWEEN (B)(6) 2024, WHEN THE CUSTOMER EXPERIENCED AN ISSUE WITH TISSUE-TEK VIP 6 AI VACUUM INFILTRATION PROCESSOR. CUSTOMER NOTICED BIOPSIES WERE INCREDIBLY HARD AND BRITTLE AS WELL AS DIFFICULT TO CUT. WHEN STAINED, THE NUCLEAR DETAIL WAS ALSO FOUND TO BE VERY POOR. PER CUSTOMER, THIS ISSUE HAD BEEN PREVIOUSLY NOTICED SOMEWHAT ON OTHER SAMPLES, BUT IT WAS ASSUMED IT TO BE STAINING ARTEFACT OR POOR PROCESSING DUE TO THE USE OF A NEW TYPE OF SPONGE IN THE BIOPSY CASSETTES. THE BACKLOG IN THE LABORATORY LED TO A DELAYED DISCOVERY OF THE ISSUE AND HENCE THE ASSUMPTION OF THE ABOVE PROVIDED TIME-SPAN OF 8 DAYS WHEN THE INCIDENT MIGHT HAVE TAKEN PLACE. 123 PATIENTS & APPROXIMATELY 377 BLOCKS WERE AFFECTED IN THE INCIDENT, ALL THE SAMPLES WERE GASTRO INTESTINAL BIOPSIES. ON (B)(6) 2024, CUSTOMER REPORTED SAKURA FINETEK EUROPE THAT ONE PATIENT UNDERWENT ONE RE-BIOPSY FOR SEVERAL LOCATIONS IN THE GI-TRACT. ALL OTHER PATIENTS RECEIVED DIAGNOSES FROM THE IMPACTED TISSUES OF THE INCIDENT AND NO OTHER REBIOPSIS WERE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903441 TISSUE-TEK® VIP® 6 AI VACUUM INFILTRATION PROCESSOR; 230 VAC, 50/60 HZ, 6 A VIP 6 AI IEO SAKURA SEIKI CO., LTD. 6042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other