BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX Z+

    MDR report key: 14838017 · Received June 27, 2022

    Report

    Report Number
    3005473391-2022-00166
    Event Type
    Injury
    Date Received
    June 27, 2022
    Date of Event
    April 19, 2022
    Report Date
    March 1, 2024
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    UDI-DI
    00810275011089
    PMA / PMN Number
    K172811
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 GASTRIC/ESOPHAGEAL LEAK AND ABSCESS AFTER THE PROCEDURE. 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: 1690, AND 2001. UPDATING HEALTH EFFECT IMPACT CODE (F) TO ONLY INCLUDE: 4614, AND 4607. UPDATING TYPE OF INVESTIGATION (B) TO ONLY INCLUDE: 4110, 4109, 4112, 4115, AND 4111.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A HIATAL HERNIA REPAIR FOLLOWED BY TIF PROCEDURE. THE PATIENT RETURNED TO THE HOSPITAL AND WAS DIAGNOSED WITH A GASTRIC/ESOPHAGEAL LEAK AND AN ABSCESS AT A FASTENER LOCATION. THE PHYSICIAN BELIEVES THE PATIENT'S LEAK AND ABSCESS WAS CAUSED BY THE PATIENT "WRETCHING" POST-TIF PROCEDURE. THE PATIENT REPORTEDLY MADE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910747 ESOPHYX Z+ ODE ODE ENDOGASTRIC SOLUTIONS, INC R2007 403217 00810275011089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H