BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX Z+

    MDR report key: 18918839 · Received March 16, 2024

    Report

    Report Number
    3005473391-2024-00214
    Event Type
    Injury
    Date Received
    March 16, 2024
    Date of Event
    February 12, 2024
    Report Date
    August 24, 2024
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    UDI-DI
    00810275011089
    PMA / PMN Number
    K172811
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHYSICIAN IS NOT ALLEGING THE ESOPHYX DEVICE MALFUNCTIONED THUS CONTRIBUTING TO OR CAUSING THE REPORTED TEMPORARY DYSPHAGIA . THE DEVICE WAS DISCARDED AT THE MEDICAL FACILITY AND IS UNAVAILABLE FOR RETURN TO ENDOGASTRIC SOLUTIONS (EGS). BASED ON THE AVAILABLE INFORMATION RECEIVED BY EGS, THE CAUSE OF THE REPORTED TEMPORARY DYSPHAGIA CANNOT BE DETERMINED. NO ROOT CAUSE WAS IDENTIFIED; THUS, IT IS UNKNOWN IF THE USE OF BOUGIE DURING THE HHR, HHR PROCEDURE, TIF PROCEDURE, USE OF THE BOUGIE PRIOR TO THE TIF PROCEDURE, OR A COMBINATION OF EVENTS CONTRIBUTED TO OR CAUSED THIS ADVERSE EVENT.

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW OF EGS COMPLAINTS [(B)(4)] BY MERIT MEDICAL'S SYSTEMS INC, [(B)(4)] PMS TEAM FOR ANY IDENTIFIED COMPLAINT DISCREPANCIES REQUIRING CORRECTIONS/ADDITIONAL INFORMATION PER 21 CFR 803. MERIT MEDICAL SYSTEMS INC. (B)(6). CORRECTIONS TO THIS MEDWATCH REPORT: D6A - IMPLANT DATE WAS ADDED UPDATED G3- DATE RECEIVED BY MANUFACTURER MERIT MEDICAL UPDATED/REPLACED G CODE TO INCLUDE: 788 UPDATED/REPLACED B CODE TO INCLUDE: 4114 UPDATED/REPLACED C CODE TO INCLUDE: 3221 UPDATED/REPLACED D CODE TO INCLUDE: 67.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A CTIF PROCEDURE (CONSISTING OF A HIATAL HERNIA REPAIR (HHR) PROCEDURE CONDUCTED EITHER LAPAROSCOPICALLY OR ROBOTICALLY, FOLLOWED CONSECUTIVELY BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE). ONE BOUGIE WAS USED PRIOR TO THE INSERTION OF THE ESOPHYX DEVICE TO DILATE THE ESOPHAGUS. THE TIF PROCEDURE WAS COMPLETED, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT RETURNED TO THE HOSPITAL ON AN UNKNOWN DATE AND WAS HELD FOR OBSERVATION COMPLAINING OF AN INABILITY TO KEEP FOOD AND LIQUIDS DOWN. THE PATIENT WAS INITIALLY SEEN BY AN ER PHYSICIAN AND UNDERWENT A BARIUM ESOPHAGRAM. THE PATIENT WAS LATER SEEN BY THE TIF PHYSICIAN AND DIAGNOSED WITH DYSPHAGIA. FOLLOWING THE TIF PHYSICIAN'S EVALUATION AND PATIENT'S OVERNIGHT STAY FOR OBSERVATION, THE ER PHYSICIAN CONFIRMED THE PATIENT WAS ABLE TO SWALLOW, KEEP FOOD AND LIQUID DOWN, AND THE DYSPHASIA SYMPTOMS HAD RESOLVED. AS OF (B)(6) 2024, THE PATIENT WAS RELEASED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266505 ESOPHYX Z+ ODE ODE ENDOGASTRIC SOLUTIONS, INC R2007 403301 00810275011089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown