BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX Z+

    MDR report key: 14500126 · Received May 25, 2022

    Report

    Report Number
    3005473391-2022-00163
    Event Type
    Injury
    Date Received
    May 25, 2022
    Date of Event
    May 12, 2021
    Report Date
    March 1, 2024
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    PMA / PMN Number
    K172811
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ENDOGASTRIC SOLUTIONS INITIALLY BECAME AWARE OF A POTENTIAL ADVERSE EVENT ON 18 FEBRUARY 2022. AFTER MULTIPLE DOCUMENTED ATTEMPTS TO OBTAIN INFORMATION, IT WAS NOT UNTIL 18 MAY 2022 WHEN THIS ADVERSE EVENT WAS CONFIRMED BY THE PHYSICIAN. THE PHYSICIAN IS NOT ALLEGING A PRODUCT MALFUNCTION CAUSED OR CONTRIBUTED TO THE PATIENT ADVERSE EVENT AND THE PRODUCT WAS NOT RETURNED TO ENDOGASTRIC SOLUTIONS (EGS) FOR EVALUATION. THE DEVICE WAS DISCARDED AT THE MEDICAL FACILITY BY THE HOSPITAL STAFF AND IS UNAVAILABLE FOR RETURN TO EGS. THE PHYSICIAN IS ALLEGING THE TIF PROCEDURE MAY HAVE CAUSED/CONTRIBUTED TO THE REPORTED ESOPHAGEAL LEAK. BASED ON THE AVAILABLE INFORMATION RECEIVED BY EGS, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    UPDATING HEALTH EFFECT CLINICAL CODE (E) TO ONLY INCLUDE: 2399, AND 1729. UPDATING TYPE OF INVESTIGATION (B) TO ONLY INCLUDE: 4112, 4109, 4110, AND 4115.

    Description of Event or Problem · 0

    THE PHYSICIAN STATED A PATIENT WHO UNDERWENT A SUCCESSFULLY COMPLETED TIF PROCEDURE RETURNED TO THE HOSPITAL THREE DAYS POST-PROCEDURE WITH CHEST DISCOMFORT AND ATRIAL FIBRILLATION. AFTER BEING ADMITTED TO THE HOSPITAL, THE PATIENT UNDERWENT A CT SCAN AND BARIUM SWALLOW, AND WAS DIAGNOSED WITH A DISTAL ESOPHAGEAL LEAK NEAR THE GASTROESOPHAGEAL JUNCTION. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER MEDICAL FACILITY WHERE AN ESOPHAGEAL STENT WAS PLACED. THE PATIENT IS REPORTEDLY DOING WELL AS OF (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259998 ESOPHYX Z+ ODE ODE ENDOGASTRIC SOLUTIONS, INC R2007

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Hospitalization| R