BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX12 M ESOPHAGEAL TEMPERATURE PROBE

    MDR report key: 22905560 · Received August 27, 2025

    Report

    Report Number
    3009437315-2025-00004
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    July 25, 2025
    Report Date
    August 27, 2025
    Manufacturer
    CIRCA SCIENTIFIC, INC.
    Product Code
    FLL
    UDI-DI
    10851498007135
    PMA / PMN Number
    K222311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    MINIMAL BLEEDING MAY HAVE RESULTED FROM THE TIP SEPARATING LEADING TO A SHARP EDGE. NO REASON FOR TIP SEPARATION COULD BE CONCLUDED BASED ON EVIDENCE OF ADHESIVE AT THE BOND LOCATION, A REVIEW OF TESTING PER THE DHR, AND PULL TESTING OF SIMILAR PRODUCT.

    Description of Event or Problem · 0

    UPON REMOVAL, THERE WAS BLOOD, AND THE PROBE TIP WAS MISSING. ADDITIONALLY, THE SAME PROBE REACHED A HIGH TEMPERATURE ON ONE OF THE CHANNELS BEFORE THE TEMPERATURE BAR DISAPPEARED. THE SAME ISSUE OCCURRED WITH A SECOND SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380118 MATRIX12 M ESOPHAGEAL TEMPERATURE PROBE ESOPHAGEAL TEMPERATURE PROBE FLL CIRCA SCIENTIFIC, INC. CS-31EP 14661 10851498007135

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other