BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX Z+

    MDR report key: 18784562 · Received February 26, 2024

    Report

    Report Number
    3005473391-2024-00211
    Event Type
    Injury
    Date Received
    February 26, 2024
    Date of Event
    January 25, 2024
    Report Date
    August 19, 2024
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    PMA / PMN Number
    K172811
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 F CODES TO INCLUDE 4607,4617, 4641 UPDATED/REPLACED G CODE TO INCLUDE 788 UPDATED//REPLACED C CODE TO INCLUDE 3221 UPDATED/REPLACED F CODE TO INCLUDE 67.

    Additional Manufacturer Narrative · 0

    THE PHYSICIAN IS ALLEGING THE TIF PROCEDURE CONTRIBUTING TO/CAUSING THE REPORTED PERFORATION. ENDOGASTRIC SOLUTIONS (EGS) HAS BEEN UNABLE TO CONFIRM OR FURTHER INVESTIGATE THE ALLEGATION AS NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO EGS FOLLOWING FOUR WRITTEN ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT. THUS, IT IS UNKNOWN/UNCONFIRMED IF THE HHR PROCEDURE, TIF PROCEDURE, OR A COMBINATION OF EVENTS, CONTRIBUTED TO OR CAUSED THE REPORTED PERFORATION. A FOLLOW-UP REPORT MAY BE SUBMITTED AT A LATER DATE IF ADDITIONAL INFORMATION IS OBTAINED BY EGS.

    Description of Event or Problem · 0

    A PATIENT WHO 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) WAS DIAGNOSED WITH A PERFORATION OF UNKNOWN SIZE AND AT AN UNKNOWN LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117958 ESOPHYX Z+ ODE ODE ENDOGASTRIC SOLUTIONS, INC R2007

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R| H