BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HISTOCORE PEGASUS

    MDR report key: 21813025 · Received April 10, 2025

    Report

    Report Number
    8010478-2025-00021
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    March 12, 2025
    Report Date
    April 10, 2025
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVEALED THE FOLLOWING: THE INSTRUMENT LOGS WERE ANALYZED BY THE LBS ENGINEER, QUALITY ASSURANCE & REGULATORY AFFAIRS AND NO INSTRUMENT ERROR WAS DETECTED DURING THE PROCESSING STEPS THAT COULD CONCEIVABLY BE LINKED TO THE DAMAGED TISSUES. THE INCIDENT WAS USER RELATED DUE TO AN APPLICATION ISSUE, RESPECTIVELY THE USAGE OF CONTAMINATED REAGENTS. BASED ON THE INVESTIGATION RESULTS, LEICA BIOSYSTEMS HAVE RECOMMENDED, THAT THE FIELD SERVICE ENGINEER ASSIST AT THE AFFECTED CUSTOMER SITE IN REPLACING ALL REAGENTS AND WAXES, AND THAT THE INSTRUMENT BE DEEPLY CLEANED AND RUN A ROUTINE PROTOCOL TO VERIFY IF TISSUE QUALITY IS BACK TO NORMAL. THE FIELD SERVICE ENGINEER CONFIRMED THAT THE PEGASUS INSTRUMENT WAS DEEP CLEANED ACCORDING TO ¿TSB 2024-009 ¿ DEEP CLEAN PROCEDURE AND DECOMMISSION PROCEDURE¿.

    Description of Event or Problem · 0

    ON 12 MARCH 2025 LEICA BIOSYSTEMS RECEIVED THE CONFIRMATION, THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE PEGASUS, TISSUE PROCESSOR. AS A RESULT, EIGHT (8) TISSUES WERE UNDIAGNOSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1664689 HISTOCORE PEGASUS PROCESSOR, TISSUE, AUTOMATED IEO LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE PEGASUS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other