BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HISTOCORE PEGASUS

    MDR report key: 21206736 · Received January 22, 2025

    Report

    Report Number
    8010478-2025-00020
    Event Type
    Injury
    Date Received
    January 22, 2025
    Date of Event
    December 24, 2024
    Report Date
    June 4, 2025
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    UDI-DI
    04049188216397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERIMS REPORT ISSUED BY THE INVESTIGATING LEICA BIOSYSTEMS APPLICATIONS CONSULTANT ON JANUARY 24, 2025, IDENTIFIED THE FOLLOWING PRELIMINARY CONCLUSIONS: - ANALYSIS OF H&E (STAINING) IMAGES OBTAINED FROM DAMAGED TISSUE DEMONSTRATES ARTIFACTS CONSISTENT WITH WATER CONTAMINATION. - ALL ALCOHOL REAGENTS WERE WITHIN THE SPECIFIED PURITY RANGE FOR PROCESSING. - THE AFFECTED DEVICE WAS SHOWN TO HAVE SIGNIFICANT ALDEHYDE CONTAMINATION IN ALL THE XYLENE BOTTLES AND WAX BATHS. THIS STRONGLY SUGGESTS THAT THE WATER CONTAMINATION ORIGINATED FROM ALDEHYDE IN THE XYLENE AND WAX BATHS. INADEQUATE REMOVAL OF WATER FROM THE TISSUE RESULTED IN SUBPAR INFILTRATION OF MOLTEN WAX. THIS RESULTS IN THE ¿COOKED¿ PHENOMENON OBSERVED WITH THE AFFECTED BIOPSY TISSUES. THE AFFECTED DEVICE WILL BE RETURNED TO THE MANUFACTURER'S WORKSHOP FOR FURTHER INTENSIVE TESTING AND EVALUATION.

    Additional Manufacturer Narrative · 0

    THE INCIDENT WAS RELATED TO A FOREIGN OBJECT, A SMALL METAL WIRE FRAGMENT, GETTING STUCK IN LIQUID VALVE 4. THIS PIECE OF SMALL METAL WIRE WAS REMOVED, AND TESTS WERE REPEATED AT CUSTOMER SITE, INCLUDING FURTHER TESTS ON DIFFERENT VALVES. A LOGFILE ANALYSIS DID NOT REVEAL ANY ABNORMAL EVENTS RECORDED FOR THE TIME OF THE INCIDENT. NO LEAKAGE WAS FOUND IN THE ROTARY VALVE AND THE DEVICE PASSED ALL AIR MANIFOLD AND LIQUID VALVE PERFORMANCE TESTS. BASED ON THE ORIGINAL INVESTIGATION AT CUSTOMER SITE, AS WELL AS FURTHER INTENSIVE TESTING AND EVALUATION IN THE MANUFACTURER'S WORKSHOP, DURING WHICH NO DEVICE-RELATED DEFICIENCIES WERE IDENTIFIED, THE FINAL ROOT CAUSE FOR THIS INCIDENT HAS BEEN DETERMINED TO BE THE FOLLOWING: THE INTRODUCTION OF A SMALL FOREIGN OBJECT INTO THE LIQUID SYSTEM OF THE DEVICE INTERFERED WITH THE PROPER FUNCTIONALITY OF LIQUID VALVE 4. THIS IS THE ONLY CASE LEIA BIOSYSTEMS NUSSLOCH GMBH HAS BEEN MADE AWARE OF FOR THIS ROOT CAUSE. THIS CASE WILL THEREFORE BE TREATED AS A SINGLE CASE AT THIS TIME.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION OF THE INCIDENT IS CURRENTLY UNDERWAY AND A FOLLOW UP WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. FOLLOWING THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2024 LEICA BIOSYSTEMS RECEIVED THE CONFIRMATION, THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE PEGAUS, TISSUE PROCESSOR. AS A RESULT, 5 TISSUE SAMPLES WERE UNDIAGNOSABLE, AND FIVE PATIENTS NEED RE-BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791504 HISTOCORE PEGASUS PROCESSOR, TISSUE, AUTOMATED IEO LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE PEGASUS 04049188216397

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other