BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHYX2 HD

    MDR report key: 6967179 · Received October 20, 2017

    Report

    Report Number
    3005473391-2017-00105
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    September 22, 2017
    Report Date
    October 20, 2017
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC.
    Product Code
    ODE
    UDI-DI
    00810275011065
    PMA / PMN Number
    K171307
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS AVAILABLE FROM THE HOSPITAL FOR EVALUATION; AN ENGINEERING DEVICE EVALUATION WAS PERFORMED ON THE RETURNED PRODUCT. THE HELICAL RETRACTOR HELIX AND CENTERING NEEDLE WERE FOUND STUCK IN THE TISSUE MOLD CHANNEL, BENT APPROXIMATELY 75° AND WERE PROTRUDING FROM THE TISSUE MOLD 0.25" - 0.38". A REVIEW OF THE DHR INDICATES THE MATERIALS AND ASSEMBLY PROCESS WERE TO SPECIFICATIONS AND PASSED ALL FINAL TESTING CRITERIA. THE ROOT CAUSE OF THE FAILURE COULD NOT BE DEFINITIVELY DETERMINED. THERE IS NO REPORTED PATIENT INJURY; HOWEVER, IF THE FAILURE WERE TO RECUR, IT MAY REQUIRE INTERVENTION TO PREVENT SERIOUS INJURY.

    Description of Event or Problem · 1

    THE USER REPORTED THE HELICAL RETRACTOR (BOTH THE HELIX AND CENTERING NEEDLE) WERE BENT/CURVED. AS A RESULT, THE USER WAS UNABLE TO ENGAGE TISSUE. THE INITIAL DEVICE WAS UNEVENTFULLY REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECONDARY R2005 DEVICE. THERE IS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743609 ESOPHYX2 HD ODE ODE ENDOGASTRIC SOLUTIONS, INC. C02042-01 402450 00810275011065

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR