BEUDAMED
    FDA Adverse Event Death Summary report: N

    ESOPHYX Z+

    MDR report key: 19766720 · Received July 17, 2024

    Report

    Report Number
    3005473391-2024-00229
    Event Type
    Death
    Date Received
    July 17, 2024
    Date of Event
    December 6, 2023
    Report Date
    July 17, 2024
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    PMA / PMN Number
    K240879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A MEDWATCH SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW OF EGS COMPLAINTS [3005473391] BY MERIT MEDICAL'S SYSTEMS INC, [1721504] PMS TEAM FOR ANY IDENTIFIED COMPLAINT DISCREPANCIES REQUIRING CORRECTIONS/ADDITIONAL INFORMATION PER 21 CFR 803. MERIT MEDICAL SYSTEMS INC. 1600 WEST MERIT PARKWAY, SOUTH JORDAN, UT 84095, 801-253-1600. CORRECTIONS TO EGS MEDWATCH REPORT: B.7 HISTORY UPDATED TO INCLUDE: HIATAL HERNIA, GERD, ABDOMINAL SURGERY. D6A - IMPLANT DATE ADDED. UPDATED G CODE TO 788. REPLACED D CODE TO INCLUDE 67. H.1 UPDATED TO REFLECT PATIENT DEATH. H.8 UPDATED TO REFLECT [X] INITIAL USE.

    Additional Manufacturer Narrative · 0

    THE PHYSICIAN IS NOT ALLEGING A PRODUCT MALFUNCTION CAUSING OR CONTRIBUTING TO THE ADVERSE EVENT. THIS IS BEING REPORTED AS THE DEATH OF A PATIENT DUE TO SEPSIS SOMETIME AFTER THE PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 0

    WITHIN WEEKS PRIOR TO THE CTIF PROCEDURES, A PATIENT UNDERWENT A SURGICAL OPERATION IN THE ABDOMEN AREA. FOLLOWING THE PROCEDURE IN THE ABDOMEN AREA A PATIENT UNDERWENT A CTIF PROCEDURE (CONSISTING OF A HIATAL HERNIA REPAIR (HHR) PROCEDURE CONDUCTED LAPAROSCOPICALLY, FOLLOWED BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE). FOLLOWING BOTH PROCEDURES, A PATIENT EXPERIENCED A POST PROCEDURES EVENT. THE PATIENT WAS DIAGNOSED WITH SEPSIS ON AN UNKNOWN DATE AND SUBSEQUENTLY PASSED AWAY ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352275 ESOPHYX Z+ ODE ODE ENDOGASTRIC SOLUTIONS, INC R2007 UKN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| L ABDOMINAL SURGERY