BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOCORE ARCADIA H

    MDR report key: 18948764 · Received March 21, 2024

    Report

    Report Number
    8010478-2024-00007
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    February 21, 2024
    Report Date
    March 21, 2024
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IDW
    UDI-DI
    04049188205988
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ON 21. FEBRUARY 2024, LEICA BIOSYSTEMS WAS CONTACTED BY THE CUSTOMER AND PROVIDED THE FOLLOWING INFORMATION: THE INSTRUMENT CAUGHT FIRE DURING USE. DURING THE INITIAL CONTACT WITH THE CUSTOMER LEICA BIOSYSTEMS WAS INFORMED THAT NO TISSUE HAD BEEN NEGATIVELY AFFECTED BY THIS INCIDENT AND THAT NEITHER THE CUSTOMER NOR A THIRD PARTY WERE NEGATIVELY IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926419 HISTOCORE ARCADIA H HISTOCORE ARCADIA H IDW LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE ARCADIA H 04049188205988

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown