BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-CATH ESOPHAGEAL TEMPERATURE PROBE

    MDR report key: 13595998 · Received February 24, 2022

    Report

    Report Number
    3009437315-2022-00002
    Event Type
    Injury
    Date Received
    February 24, 2022
    Date of Event
    January 26, 2022
    Report Date
    February 24, 2022
    Manufacturer
    CIRCA SCIENTIFIC, INC.
    Product Code
    FLL
    UDI-DI
    10860237000214
    PMA / PMN Number
    K112376
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PROBE WAS DISCARDED BY THE HOSPITAL AFTER USE AND THEREFORE NO VISUAL INSPECTION OF THE COMPLAINT PROBE COULD BE PERFORMED. PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS, LABELING AND EVALUATION OF A PROBE FROM RELEASED STOCK. BASED ON EVALUATION OF SAMPLE FROM RELEASED STOCK AND ENGINEERING CHANGE REVIEW, THERE IS NO PRODUCT CHANGE OR DEFECT THAT WOULD ATTRIBUTE TO THE BLEEDING. HOSPITAL COMMUNICATED EGD WAS UNREVEALING WITH NO CLEAR SOURCE OF BLEEDING, MOST LIKELY OROPHARYNGEAL INJURY WITH BLOOD INTO ESOPHAGUS. ESOSURE ESOPHAGEAL RETRACTOR WITH AN OG TUBE WAS ALSO USED DURING THE PROCEDURE.

    Description of Event or Problem · 0

    DURING PROBE INSERTION THEY ENCOUNTERED RESISTANCE. DOCTOR ALSO USES ESOSURE WITH AN OG TUBE. OG TUBE WAS INSERTED BEFORE CIRCA PROBE. TOWARD END OF CASE BLEEDING WAS NOTED. ENT WAS CALLED AND DIDN'T NOTE ANY DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2401020 S-CATH ESOPHAGEAL TEMPERATURE PROBE ESOPHAGEAL TEMPERATURE PROBE FLL CIRCA SCIENTIFIC, INC. CS-2001 17394-01 10860237000214

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization ESOSURE ESOPHAGEAL RETRACTOROG TUBE