BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-CATH ESOPHAGEAL TEMPERATURE PROBE

    MDR report key: 13595602 · Received February 24, 2022

    Report

    Report Number
    3009437315-2022-00001
    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
    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 ESOPHAGEAL BLEEDING. HOSPITAL COMMUNICATED THAT THE SITUATION WAS LIKELY DUE TO IRREGULAR ANATOMY OF PATIENT'S ESOPHAGUS AND DIFFICULT INSERTION OF THE PROBE.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED THAT THEY ENCOUNTERED RESISTANCE UPON INSERTION INTO THE ESOPHAGUS. THEY TRIED MULTIPLE TIMES TO INSERT PROBE AND MET RESISTANCE. AN INJURY APPEARED TO HAVE OCCURRED EVIDENCY BY BLEEDING. REPORTS PATIENT WAS DOING WELL ON THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334245 S-CATH ESOPHAGEAL TEMPERATURE PROBE ESOPHAGEAL TEMPERATURE PROBE FLL CIRCA SCIENTIFIC, INC. CS-2001 17394-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization