BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX Z+

    MDR report key: 17890710 · Received October 6, 2023

    Report

    Report Number
    3005473391-2023-00200
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    September 11, 2023
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATING HEALTH EFFECT CLINICAL CODE (E) TO ONLY INCLUDE: 2399. UPDATING HEALTH EFFECT IMPACT CODE (F) TO ONLY INCLUDE: 4614, 4621, 4641, AND 4607. UPDATING TYPE OF INVESTIGATION (B) TO ONLY INCLUDE: 4112, 4109, 4110, 4115, 3331, 4111.

    Additional Manufacturer Narrative · 0

    THE TIF PHYSICIAN IS NOT ALLEGING THE ESOPHYX DEVICE MALFUNCTIONED THUS NOT CONTRIBUTING TO OR CAUSING THE REPORTED PERFORATION. THE TIF PHYSICIAN DOES NOT KNOW WHAT CONTRIBUTED TO OR CAUSED THE REPORTED PERFORATION. BASED ON THE AVAILABLE INFORMATION RECEIVED BY EGS AND THE MEDICAL OPINION OF THE TIF PHYSICIAN, THE CAUSE OF THE REPORTED PERFORATION CANNOT BE DETERMINED. IT CANNOT BE CONCLUSIVELY DETERMINED IF THE PATIENT'S FRIABLE TISSUE, HHR, PRE-TIF EGD, ESOPHAGEAL DILATION BY BOUGIES, TIF PROCEDURE, POST-TIF EGD, OR A COMBINATION OF EVENTS, CONTRIBUTED TO OR CAUSED THE ADVERSE EVENT.

    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: B.2 - UPDATED TO INCLUDE [X] LIFE-THREATENING B.7 HISTORY UPDATED TO INCLUDE HIATAL HERNIA GERD D6A - IMPLANT DATE ADDED UPDATED E CODE TO INCLUDE 2399 UPDATED F CODE TO INCLUDE 4607 UPDATED G CODE TO 788 UPDATED B CODE TO INCLUDE 4115 REPLACED C CODE TO INCLUDE 3221 REPLACED D CODE TO INCLUDE 67 H.8 UPDATED TO REFLECT [X] INITIAL USE.

    Description of Event or Problem · 0

    A PATIENT WITH NOTED FRIABLE TISSUE UNDERWENT A HIATAL HERNIA REPAIR (HHR) PROCEDURE FOLLOWED BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE WHERE LAPAROSCOPIC PORTS USED DURING THE HHR WERE LEFT IN PLACE DURING THE TIF PROCEDURE. TWO BOUGIES WERE USED PRIOR TO THE INSERTION OF THE ESOPHYX DEVICE AND THE TIF PROCEDURE WAS SUCCESSFULLY COMPLETED. DURING THE POST-TIF EGD, THE TIF PHYSICIAN NOTED A PERFORATION APPROXIMATELY 3-4CM ABOVE THE Z-LINE. THE TIF PHYSICIAN PLACED CLIPS ENDOSCOPICALLY AND THE HHR PHYSICIAN PLACED AN UNKNOWN NUMBER OF SUTURES LAPAROSCOPICALLY TO TREAT THE PERFORATION. ADDITIONALLY, THE PATIENT WAS PLACED ON AUGMENTIN (ANTIBIOTIC) STARTING INTRAOPERATIVELY AND ENDED FIVE DAYS POST-PROCEDURES. THE PATIENT WAS ADMITTED TO THE MEDICAL FACILITY POST PROCEDURES. THE PATIENT WAS SUBSEQUENTLY DISCHARGED ON (B)(6) 2023 AND IS REPORTEDLY DOING WELL AS ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239335 ESOPHYX Z+ ODE ODE ENDOGASTRIC SOLUTIONS, INC R2007 403332 00810275011089

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Life Threatening| H| R BOUGIE [X2] INFLATIONS.