BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HISTOCORE PEGASUS

    MDR report key: 23308216 · Received October 16, 2025

    Report

    Report Number
    8010478-2025-00031
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    September 9, 2025
    Report Date
    October 16, 2025
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    UDI-DI
    04049188216397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATING ENGINEER, QUALITY ASSURANCE & REGULATORY AFFAIRS HAS DETERMINED THE FOLLOWING: IT CAN BE CONFIRMED THAT S7 BOTTLE CONTAINING 79 % ETHANOL WAS REMOVED FROM THE INSTRUMENT FOR 3 SECONDS, REINSERTED, AND THE STATION PROPERTIES WERE RESET TO 100 % ETHANOL. THE CONCENTRATION OF S7 WAS SET TO 100 % IN THE SYSTEM BUT REAGENT IN S7 WAS NOT REPLACED AND ITS ACTUAL CONCENTRATION WAS AT 79 %. BOTTLE 7 WAS USED AS THE FINAL REAGENT ETHANOL IN MULTIPLE RUNS. THE INSUFFICIENT ETHANOL CONCENTRATION WAS NOT ADEQUATE TO COMPLETELY REPLACE THE WATER IN THE TISSUE, ULTIMATELY LEADING TO POOR TISSUE PROCESSING QUALITY. THE CUSTOMER HAS REPLACED ALL REAGENTS AND PERFORMED A TEST RUN WITH NO ISSUES REPORTED. THE CUSTOMER HAS RESUMED USAGE OF THE DEVICE IN PREPARATION OF TISSUE SAMPLES FOR PATIENT DIAGNOSIS WITHOUT ISSUES. IT WAS RECOMMENDED TO THE CUSTOMER TO SET UP SEPARATE LOG IN PROFILES FOR EVERY USER INSTEAD OF USING A GENERIC PROFILE FOR ALL USERS. THE DEVICE IS WORKING AS INTENDED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT A CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE PEGASUS TISSUE PROCESSOR. ACCORDING TO THE CUSTOMER, THERE WERE TWO RUNS PERFORMED ON (B)(6) 2025, AND ONE RUN PERFORMED ON (B)(6) 2025, WHICH WERE AFFECTED. THE TISSUE WAS DESCRIBED BY THE CUSTOMER AS UNDER PROCESSED. AFTER THE RUN PERFORMED ON (B)(6) 2025, THE CUSTOMER SUSPENDED THE USE OF THE DEVICE. ON (B)(6) 2025, LEICA BIOSYSTEMS NUSSLOCH GMBH WAS INFORMED THAT ONE PATIENT SAMPLE WAS UNABLE TO BE DIAGNOSED. ON (B)(6) 2025, LEICA BIOSYSTEMS NUSSLOCH GMBH RECEIVED FURTHER INFORMATION THAT THE NUMBER OF NON-DIAGNOSABLE CASES HAD INCREASED TO TWO AND THAT FOR BOTH CASES A RE-BIOPSY WOULD BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2393074 HISTOCORE PEGASUS PROCESSOR, TISSUE, AUTOMATED IEO LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE PEGASUS 04049188216397

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female