BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HISTOCORE PEARL

    MDR report key: 14216699 · Received April 27, 2022

    Report

    Report Number
    8010478-2022-00003
    Event Type
    Injury
    Date Received
    April 27, 2022
    Date of Event
    March 26, 2022
    Report Date
    October 30, 2023
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    UDI-DI
    04049188198907
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE INCIDENT WAS INSTRUMENT RELATED ABOUT A LEVEL SENSOR HEATING PROBLEM. DUE TO THIS ISSUE, THE SPECIMENS WERE NOT COVERED BY 70% ALCOHOL REAGENT OF STATION S3 FOR ABOUT 18 MINUTES. THE RETORT TEMPERATURE WAS ALSO AROUND 40 DEGREES CELSIUS DURING THIS PERIOD, WHICH IS TOO LOW FOR THE TISSUE PROCESSING. THE TEMPERATURE OF THE TISSUE PROCESSING PROTOCOL USED BY THE CUSTOMER AND RECOMMENDED BY LEICA BIOSYSTEMS NUSSLOCH SHOULD BE 45 DEGREES CELSIUS. THE LEICA BIOSYSTEMS SERVICE CUSTOMER AND SERVICE ENGINEERING MANAGER RECOMMENDED TO REPLACE THE LEVEL SENSOR. FURTHER RECOMMENDATION FROM THE LEICA BIOSYSTEMS FIELD APPLICATIONS SPECIALIST WAS TO MAINTAIN AND REPLACE THE CLEANING REAGENT ON A REGULAR BASIS, AND TO CLEAN THE LEVEL SENSOR AS DESCRIBED IN THE INSTRUCTION FOR USE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A CUSTOMER REPORTED TO LEICA BIOSYSTEMS THAT ON (B)(6) 2022 THEY EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE PEARL. AS A RESULT THE TISSUE WAS UNDIAGNOSABLE, AND A REBIOPSY FOR 2 PATIENTS WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479382 HISTOCORE PEARL HISTOCORE PEARL IEO LEICA BIOSYSTEMS NUSSLOCH GMBH 04049188198907

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other