BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX12 M ESOPHAGEAL TEMPERATURE PROBE

    MDR report key: 22071935 · Received May 22, 2025

    Report

    Report Number
    3009437315-2025-00002
    Event Type
    Injury
    Date Received
    May 22, 2025
    Date of Event
    April 18, 2025
    Report Date
    May 22, 2025
    Manufacturer
    CIRCA SCIENTIFIC, INC.
    Product Code
    FLL
    PMA / PMN Number
    K222311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO TESTING COULD BE PERFORMED AS PROBE WAS NOT RETURNED. BASED ON SIMILAR COMPLAINT TESTING, THERE IS NO KNOWN DEFECT THAT WOULD PREVENT PROPER PLACEMENT. ROOT CAUSE IS USER DID NOT APPEAR TO FOLLOW INSTRUCTIONS FOR USE AND VERIFY PROPER PLACEMENT WITH FLUOROSCOPY OR 3D MAPPING SYSTEM.

    Description of Event or Problem · 0

    ANESTHESIOLOGIST BELIEVED THAT PROBE WAS PLACED IN THE BRONCHUS AND BLEEDING OCCURRED UPON REMOVAL. PATIENT HAD TO REMAIN INTUBATED, HAD A BRONCH DONE AND WAS EXTUBATED ON MONDAY (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2260581 MATRIX12 M ESOPHAGEAL TEMPERATURE PROBE ESOPHAGEAL TEMPERATURE PROBE FLL CIRCA SCIENTIFIC, INC. CS-31EP 14660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R