BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX12 M ESOPHAGEAL TEMPERATURE PROBE

    MDR report key: 21724964 · Received March 28, 2025

    Report

    Report Number
    3009437315-2025-00001
    Event Type
    Injury
    Date Received
    March 28, 2025
    Date of Event
    March 3, 2025
    Report Date
    March 28, 2025
    Manufacturer
    CIRCA SCIENTIFIC, INC.
    Product Code
    FLL
    UDI-DI
    10851498007135
    PMA / PMN Number
    K222311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED MATRIX12 M PROBE MET DIMENSIONAL SPECIFICATIONS AND NO DEFECTS OBSERVED THAT WOULD CAUSE DIFFICULT PLACEMENT. ROOT CAUSE IS INDETERMINATE, IT IS NOT KNOWN WHY USER EXPERIENCED DIFFICULT PLACEMENT.

    Description of Event or Problem · 0

    ANESTHESIA STATED DIFFICULT PLACEMENT WITH MATRIX12 M PROBE. PROBE THOUGHT TO BE IN ESOPHAGUS, DEPLOYED AND PLACEMENT FOUND TO BE IN BRONCHIAL STEM. BLEEDING OCCURRED. NOTHING UNUSUAL ABOUT ANATOMY ACCORDING TO ANESTHESIA & STAFF. THE LAB ALSO STOCKS S-CATH M. THIS WAS USED AFTER MATRIX12 M WAS REMOVED. THEY EXTUBATED SUCCESSFULLY AFTER THE CASE WAS FINISHED USING S-CATH M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2624785 MATRIX12 M ESOPHAGEAL TEMPERATURE PROBE ESOPHAGEAL TEMPERATURE PROBE FLL CIRCA SCIENTIFIC, INC. CS-31EP 14659 10851498007135

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention