BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-CATH M ESOPHAGEAL TEMPERATURE PROBE

    MDR report key: 22414170 · Received July 7, 2025

    Report

    Report Number
    3009437315-2025-00003
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    May 26, 2025
    Report Date
    July 7, 2025
    Manufacturer
    CIRCA SCIENTIFIC, INC.
    Product Code
    FLL
    UDI-DI
    01086023700276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO TESTING COULD BE PERFORMED AS THE COMPLAINT SAMPLE HAD BEEN DISCARDED BY THE HOSPITAL. NO ALLEGED DEFECT WITH PROBE OR INSTRUCTIONS. EVENT LIKELY OCCURRED DUE TO USER PLACING PROBE DESPITE RESISTANCE BEING FELT DURING DEVICE INTRODUCTION. INSTEAD, THE USER SHOULD HAVE DETERMINED THE CAUSE OF THE RESISTANCE AND PROCEEDED ONLY AS APPROPRIATE. EXCESSIVE FORCE SHOULD NOT BE USED TO ADVANCE PROBE. TEAR IN ESOPHAGUS DUE TO DIFFICULT PLACEMENT AND FORCE USED. IT IS NOT KNOWN WHY USER HAD TROUBLE WITH INITIAL PLACEMENT OF PROBE.

    Description of Event or Problem · 0

    ANESTHETIST EXPERIENCED RESISTANCE WHEN INSERTING PROBE INTO PATIENT'S OESOPHAGUS AND HAD TROUBLE WITH INITIAL PLACEMENT OF PROBE. THE ANESTHETIST RE-TRIED TO INSERT THE PROBE INTO THE PATIENT AND WAS ABLE TO PLACE THE PROBE FULLY INTO THE OESOPHAGUS. THE ABLATION PROCEDURE WAS COMPLETED SUCCESSFULLY. IN RECOVERY BAY, THE PATIENT WAS SAID TO BE COUGHING UP BLOOD AND A SCOPE WAS REQUIRED TO INVESTIGATE - AND A TEAR IN THE OESOPHAGUS HAD BEEN IDENTIFIED AND REPAIRED. THE PATIENT WAS DISCHARGED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2768302 S-CATH M ESOPHAGEAL TEMPERATURE PROBE ESOPHAGEAL TEMPERATURE PROBE FLL CIRCA SCIENTIFIC, INC. CS-46EP 006487 01086023700276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization