BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX

    MDR report key: 11849607 · Received May 19, 2021

    Report

    Report Number
    3005473391-2021-00149
    Event Type
    Injury
    Date Received
    May 19, 2021
    Date of Event
    April 19, 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
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATING HEALTH EFFECT CLINICAL CODE (E) TO ONLY INCLUDE: 2001, AND 1776. UPDATING HEALTH EFFECT IMPACT CODE (F) TO ONLY INCLUDE: 4625, AND 4607. 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 UNABLE TO CONFIRM WHETHER THE HIATAL HERNIA REPAIR PROCEDURE AND/OR TIF PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENT'S ADVERSE EVENT. 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

    A PATIENT UNDERWENT A HIATAL HERNIA REPAIR PROCEDURE TO ADDRESS A 6CM HERNIA, FOLLOWED BY A TIF PROCEDURE. A 60FR BOUGIE WAS USED PRIOR TO INSERTING THE ESOPHYX DEVICE AND THE TIF PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS IDENTIFIED DURING OR IMMEDIATELY AFTER THE PROCEDURES. THE DAY AFTER THE PROCEDURES, THE PATIENT PRESENTED WITH CHEST PAIN AND A CT SCAN WAS PERFORMED. THE CT SCAN SHOWED A PERFORATION OF UNKNOWN SIZE IN THE AREA OF THE CARDIA, IN THE POSTERIOR ASPECT. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO TREAT THE PERFORATION AND STITCHES FROM THE HIATAL HERNIA REPAIR WERE ALSO SEEN TORN OUT OF THE RIGHT ARM OF THE CRUS. THIS WAS REPAIRED DURING THE SAME PROCEDURE. ADDITIONALLY, MULTIPLE FASTENERS ON THE POSTERIOR ASPECT OF THE ESOPHAGUS WERE SEEN "DANGLING" AND WERE REMOVED LAPAROSCOPICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745943 ESOPHYX ODE ODE ENDOGASTRIC SOLUTIONS, INC R2007 UNKONWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Hospitalization| R