BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX Z

    MDR report key: 9662512 · Received February 3, 2020

    Report

    Report Number
    3005473391-2020-00129
    Event Type
    Injury
    Date Received
    February 3, 2020
    Date of Event
    January 23, 2020
    Report Date
    February 3, 2020
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC.
    Product Code
    ODE
    UDI-DI
    00810275011089
    PMA / PMN Number
    K172811
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN IS NOT ALLEGING A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE PATIENT INJURY. THE PHYSICIAN IS ALLEGING THE TIF PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY. THE PHYSICIAN DID CONFIRM THAT THE PLACEMENT OF THE ENDOCLIPS WERE MEDICALLY NECESSARY AND THE PATIENT WAS HOSPITALIZED. THE RETURNED DEVICE WAS EVALUATED BY ENDOGASTRIC SOLUTIONS. THE RETRACTOR SYSTEM FUNCTIONED AS INTENDED. A REVIEW OF MANUFACTURING RECORDS FOR THE PRODUCT LOT INDICATE NO MANUFACTURING NON-CONFORMANCES WERE WRITTEN FOR THIS PRODUCT LOT. NO ROOT CAUSE HAS BEEN IDENTIFIED FOR THE NOTED FAILURE. THIS IS BEING REPORTED DUE TO PATIENT ADVERSE EVENT AND INTERVENTION THAT WAS MEDICALLY NECESSARY TO PRECLUDE PERMANENT DAMAGE TO A BODILY FUNCTION OR STRUCTURE.

    Description of Event or Problem · 1

    DURING A TIF PROCEDURE, THE CUSTOMER ENGAGED THE HELIX INTO THE TISSUE FOLLOWING NORMAL TIF PROTOCOL BUT THE HELIX PULLED OUT OF THE TISSUE. THE CUSTOMER WAS ENGAGING THE HELIX INTO A LARGE BLOOD BLOT ON THE LIP OF THE GEJ. THE BLOOD CLOT WAS WASHED OFF THE GEJ AND A HOLE WAS SEEN IN THE LIP OF THE GEJ. THE PROCEDURE WAS STOPPED AND 8 ENDOCLIPS WERE PLACED ON THE GEJ TO TREAT THE HOLE AND ASSOCIATED BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123495 ESOPHYX Z ODE ODE ENDOGASTRIC SOLUTIONS, INC. R2007 402842 00810275011089

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R