BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHYX Z+

    MDR report key: 10356898 · Received August 3, 2020

    Report

    Report Number
    3005473391-2020-00136
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    July 7, 2020
    Report Date
    August 3, 2020
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    UDI-DI
    00810275011089
    PMA / PMN Number
    K172811
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF MANUFACTURING RECORDS AND COMPONENT RECORDS FOR THIS PRODUCT LOT INDICATE NO NONCONFORMANCES WERE IDENTIFIED FOR ANY COMPONENTS OR DEVICE SYSTEM. THE DEVICE WAS RETURNED TO EGS AND EVALUATED. THE METAL COMPONENT WAS CONFIRMED TO BE THE CENTERING COMPONENT OF THE RETRACTOR. A FORENSIC ANALYSIS OF THE CENTERING COMPONENT WELD INDICATED A WELD WAS FULLY PRESENT AND THE WELD EXHIBITED CRACKING ON THE FRACTURE SURFACE. THIS IS THE SECOND OCCURRENCE OF A BROKEN CENTERING COMPONENT WELD OUT OF APPROXIMATELY (B)(4) MANUFACTURED PRODUCTS. THIS FAILURE MODE IS BEING MONITORED FOR FUTURE TRENDING. THIS IS BEING REPORTED AS MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE CENTERING COMPONENT TO PRECLUDE PERMANENT DAMAGE TO A BODILY STRUCTURE.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THE CENTERING COMPONENT OF THE RETRACTOR PRESENT IN THE PATIENT'S GASTROESOPHAGEAL JUNCTION TISSUE DURING THE POST-EGD AFTER A SUCCESSFUL TIF PROCEDURE. THE PHYSICIAN USED AN ENDOSCOPIC GRASPER THROUGH THE WORKING CHANNEL OF THE ENDOSCOPE TO RETRIEVE THE CENTERING COMPONENT. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820640 ESOPHYX Z+ ODE ODE ENDOGASTRIC SOLUTIONS, INC R2007 402654 00810275011089

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention