BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX Z+

    MDR report key: 19638633 · Received June 28, 2024

    Report

    Report Number
    3005473391-2024-00227
    Event Type
    Injury
    Date Received
    June 28, 2024
    Date of Event
    April 26, 2024
    Report Date
    June 28, 2024
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    UDI-DI
    00810275011089
    PMA / PMN Number
    K240879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHYSICIAN IS NOT ALLEGING THE ESOPHYX DEVICE MALFUNCTIONED THUS CONTRIBUTING TO OR CAUSING THE REPORTED PERFORATION, ESOPHAGEAL FISTULA, AND CANDIDA FUNGUS. THE DEVICE WAS DISCARDED AT THE MEDICAL FACILITY AND IS UNAVAILABLE FOR RETURN TO ENDOGASTRIC SOLUTIONS (EGS). THE PHYSICIAN DOES NOT BELIEVE THE TIF PROCEDURE NOR ESOPHYX DEVICE CAUSED OR CONTRIBUTED TO THE DEVELOPMENT OF THE PERFORATION, ESOPHAGEAL FISTULA, AND DEVELOPMENT OF FUNGUS. BASED ON THE AVAILABLE INFORMATION RECEIVED BY EGS, THE CAUSE OF THE REPORTED PERFORATION, ESOPHAGEAL FISTULA, AND DEVELOPMENT OF FUNGUS CANNOT BE CONFIRMED. IT IS UNKNOWN IF THE HHR PROCEDURE, TIF PROCEDURE, USE OF THE BOUGIES, OR A COMBINATION OF EVENTS CONTRIBUTED TO OR CAUSED THIS 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.3 - UPDATED APPROX DATE OF EVENT. B.7 - HISTORY UPDATED TO INCLUDE HIATAL HERNIA GERD D6A - IMPLANT DATE ADDED UPDATED G CODE TO 788 REPLACED D CODE TO INCLUDE 67 H.8 UPDATED TO REFLECT [X] INITIAL USE.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A CTIF PROCEDURE (CONSISTING OF A HIATAL HERNIA REPAIR (HHR) PROCEDURE CONDUCTED ROBOTICALLY, FOLLOWED CONSECUTIVELY BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE. BOTH PROCEDURES WERE COMPLETED, AND THE PATIENT RETURNED TO THE HOSPITAL ON AN UNKNOWN DATE AND WAS ADMITTED DUE TO INABILITY TO KEEP FOOD OR LIQUID DOWN. THE PATIENT UNDERWENT A CT SCAN ON (B)(6) 2024 WHICH DID NOT REVEAL A PERFORATION OR LEAK. FOLLOWING THE CT SCAN, A MEDIASTINAL DRAIN WAS PLACED ON (B)(6) 2024 AND A LEAK WAS CONFIRMED. AFTER THE DRAIN PLACEMENT AND LEAK CONFIRMATION, THE PATIENT UNDERWENT A SURGICAL PROCEDURE BY THE HHR PHYSICIAN ON AN UNKNOWN DATE TO DETECT ANY ABNORMALITIES. NO ABNORMALITIES WERE NOTED. ON (B)(6) 2024, THE PATIENT WAS STILL REPORTEDLY UNABLE TO KEEP FOOD OR LIQUID DOWN. THE PATIENT UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY (EDG) BY THE TIF PHYSICIAN AND WAS DIAGNOSED WITH A PERFORATION AND ESOPHAGEAL FISTULA. CLIPS WERE PLACED ENDOSCOPICALLY TO CLOSE THE FISTULA. FOLLOWING THE PLACEMENT OF CLIPS THE PATIENT WAS ABLE TO KEEP FOOD AND LIQUID DOWN. ADDITIONALLY, CULTURES WHICH WERE COMPLETED ON (B)(6) 2024 SHOWED CANDIDA FUNGUS. THUS, THE PT WAS PLACED ON ANTI-FUNGAL MEDICATION TO TREAT THE CANDIDA FUNGUS. THE PATIENT IS REPORTEDLY RECOVERING AND EXPECTED TO BE DISCHARGED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2292950 ESOPHYX Z+ ODE ODE ENDOGASTRIC SOLUTIONS, INC R2007 403703 00810275011089

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention| H| L