BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX Z+

    MDR report key: 12071980 · Received June 25, 2021

    Report

    Report Number
    3005473391-2021-00151
    Event Type
    Injury
    Date Received
    June 25, 2021
    Date of Event
    May 24, 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

    UPDATING HEALTH EFFECT IMPACT CODE (F) TO ONLY INCLUDE: 4625, 4607, AND 4641. UPDATING TYPE OF INVESTIGATION (B) TO ONLY INCLUDE: 4112, 4109, 4110, 4115, AND 4111. UPDATING INVESTIGATION CONCLUSIONS (D) TO ONLY INCLUDE: 4315.

    Additional Manufacturer Narrative · 1

    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 PATIENT'S ESOPHAGEAL PERFORATION. BASED ON THE AVAILABLE INFORMATION RECEIVED BY EGS, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE PHYSICIAN STATED A PATIENT WHO UNDERWENT A TIF PROCEDURE WAS DIAGNOSED WITH AN ESOPHAGEAL PERFORATION JUST ABOVE THE GEJ. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND SUBSEQUENTLY TRANSFERRED TO A DIFFERENT MEDICAL FACILITY WHERE A STENT WAS PLACED TO TREAT THE PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965793 ESOPHYX Z+ ODE ODE ENDOGASTRIC SOLUTIONS, INC R2007 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R