BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA ASP300 S

    MDR report key: 23786091 · Received December 11, 2025

    Report

    Report Number
    8010478-2025-00034
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    November 17, 2025
    Report Date
    February 20, 2026
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    UDI-DI
    04049188055972
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS MANUFACTURER INVESTIGATION OF THIS COMPLAINT BY LEICA BIOSYSTEMS IS IN PROGRESS, THE ROOT CAUSE OF THIS EVENT HAS NOT YET BEEN DETERMINED.

    Additional Manufacturer Narrative · 0

    AFTER EVALUATION OF THE INFORMATION AVAILABLE, IT WAS FOUND THAT THE ROOT CAUSE OF THE ISSUE WAS USER RELATED. THE INSTRUMENT LOGS WERE ANALYZED, AND NO INSTRUMENT ERROR WAS DETECTED DURING THE PROCESSING STEPS THAT COULD CONCEIVABLY BE LINKED TO THE DAMAGED TISSUES. THE INVESTIGATING LEICA BIOSYSTEMS FIELD SERVICE ENGINEER FOUND THAT THE REAGENTS HAD ALREADY BEEN REPLACED AND DISCARDED BY THE CUSTOMER PRIOR TO LBS PERSONNEL ARRIVAL ON SITE. IN ADDITION, IT WAS FOUND THAT THE PARAFFINS PRESENT IN THE DEVICE AT THE TIME OF THE INVESTIGATION WERE OF LOW QUALITY CONTAINING CONTAMINANTS. THE CUSTOMER WAS INSTRUCTED BY THE LEICA BIOSYSTEMS FIELD SERVICE ENGINEER TO REPLACE ALL PARAFFINS USED IN THE DEVICE. THE CUSTOMER WAS FURTHER INSTRUCTED TO PERFORM A VALIDATION RUN WITH NON-CLINICAL SAMPLES PRIOR TO RETURNING THE DEVICE TO ACTIVE USE. ON FEBRUARY 19TH, 2026, THE LEICA HELP DESK SERVICE ENGINEER DOCUMENTED THAT A TEST RUN HAD BEEN SUCCESSFULLY PERFORMED AND THAT THE DEVICE HAD BEEN RETURNED TO ACTIVE USE. TO PREVENT A RECURRENCE OF THIS ISSUE THE LEICA BIOSYSTEMS FIELD SERVICE ENGINEER CARRIED OUT A RE-TRAINING OF THE CUSTOMER ON HOW TO CORRECTLY CARRY OUT A REAGENT EXCHANGE FOR THIS DEVICE.

    Description of Event or Problem · 0

    ON 20 NOVEMBER 2025, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS WITH THE FOLLOWING COMPLAINT: "THE TISSUE PROCESSOR COMPLETED THE PROCESS WITHOUT ERRORS BUT THE SAMPLES ARE TOO SOFT AND CANNOT BE CUT" ON 20 NOVEMBER 2025, THE LEICA HELP DESK SERVICE ENGINEER DOCUMENTED "THE CUSTOMER IS CURRENTLY REPROCESSING THE SPECIMENS AND WILL INFORM US IN THE COMING DAYS ABOUT THE OUTCOME." ON 25 NOVEMBER 2025,, THE LEICA HELP DESK SERVICE ENGINEER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION "THE SAMPLES AFTER CUTTING ARE NOT VERY GOOD; THEY APPEAR ¿VITRIFIED.¿ IN ANY CASE, NOT ALL OF THEM HAVE BEEN REPROCESSED YET, AND NONE HAVE REACHED THE DIAGNOSTIC STAGE SO FAR." ON 09 DECEMBER 2025, THE LEICA HELP DESK SERVICE ENGINEER DOCUMENTED "UNFORTUNATELY, NOT ALL SAMPLES ARE DIAGNOSABLE. I SPOKE WITH THE CUSTOMER ON FRIDAY AFTERNOON (YESTERDAY WAS A NATIONAL HOLIDAY IN ((YESTERDAY WAS A NATIONAL HOLIDAY IN ITALY), AND THEY MENTIONED THAT THE HEAD PHYSICIAN WAS ASSESSING HOW TO MANAGE THE SITUATION AND TRYING TO SAVE AS MANY SAMPLES AS POSSIBLE. HOWEVER, THEY CONFIRMED THAT NOT ALL OF THEM WOULD BE DIAGNOSABLE. I ASKED FOR AN APPROXIMATE ESTIMATE OF THE NUMBER OF LOST SAMPLES COMPARED TO THE TOTAL, BUT THEY WERE UNABLE TO PROVIDE AN ANSWER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2760550 LEICA ASP300 S PROCESSOR, TISSUE, AUTOMATED IEO LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA ASP300 S 230-240V 04049188055972

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other