BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX Z+

    MDR report key: 19441936 · Received June 1, 2024

    Report

    Report Number
    3005473391-2024-00220
    Event Type
    Injury
    Date Received
    June 1, 2024
    Date of Event
    June 15, 2023
    Report Date
    May 31, 2024
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    PMA / PMN Number
    K240879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A 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 EGS MEDWATCH REPORT: D6A - IMPLANT DATE - ADDED UPDATED E CODE TO INCLUDE 2422 UPDATED/REPLACED G CODE TO INCLUDE 788 H.8 UPDATED TO REFLECT [X] INITIAL USE.

    Additional Manufacturer Narrative · 0

    THE PHYSICIAN IS NOT ALLEGING A PRODUCT MALFUNCTION CONTRIBUTED TO OR CAUSED THE ADVERSE EVENT AND THE DEVICE WAS NOT RETURNED TO ENDOGASTRIC SOLUTIONS (EGS) FOR EVALUATION. THE DEVICE WAS DISCARDED AT THE MEDICAL FACILITY BY HOSPITAL STAFF AND IS UNAVAILABLE FOR RETURN TO EGS. BASED ON THE AVAILABLE INFORMATION RECEIVED AND, THE CAUSE OF THE REPORTED INCIDENT CANNOT BE CONCLUSIVELY DETERMINED. IT CANNOT BE CONCLUSIVELY DETERMINED IF THE HHR PROCEDURE, TIF PROCEDURE, OR A COMBINATION OF BOTH CONTRIBUTED TO OR CAUSED THIS ADVERSE EVENT.

    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). THE TIF PROCEDURE WAS UNEVENTFULLY COMPLETED AND THE PATIENT WAS DISCHARGED. THE PATIENT RETURNED TO THE HOSPITAL APPROXIMATELY ONE-MONTH POST-CTIF PROCEDURE AND WAS DIAGNOSED WITH DYSPHAGIA AND A STRICTURE OF UNKNOWN SIZE AND LOCATION. A BALLOON DILATION WAS COMPLETED AT AN UNKNOWN DATE TO TREAT THE STRICTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453158 ESOPHYX Z+ ODE ODE ENDOGASTRIC SOLUTIONS, INC R2007

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention