BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHYX2 - LINK DESIGN - SHORT

    MDR report key: 3241221 · Received July 22, 2013

    Report

    Report Number
    3005473391-2013-00079
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 2, 2013
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    PMA / PMN Number
    K092400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS SEQUESTERED AND WILL NOT BE AVAILABLE FOR EVALUATION BY THE FIRM. INSTEAD, THE HOSPITAL SENT THE DEVICE TO A THIRD PARTY WHO PERFORMED AN INSPECTION OF THE DEVICE, WHICH WAS DOCUMENTED THROUGH PICTURES AND VIDEO. THE FIRM'S INVESTIGATION INCLUDED A REVIEW OF THE PHOTOGRAPHS AND VIDEO AS WELL AS CONDUCTING A METALLURGY INVESTIGATION OF COMPONENTS WITH THE SAME LOT NUMBERS AS INSTALLED IN THE DEVICE. DURING THE INVESTIGATION, THE FIRM DISCOVERED A PRODUCT PROBLEM THAT HAS BEEN PREVIOUSLY REPORTED ON MDR 3005473391-2013-00076, INVOLVING THE LOSS OF TISSUE MOLD CONTROL. ALTHOUGH THERE WAS NO INJURY TO THE PATIENT DURING THE USE OF THIS DEVICE AND THERE WAS NO INDICATION OF THIS PRODUCT PROBLEM DURING THE PROCEDURE, THIS FAILURE MODE IS NOW BEING REPORTED DUE TO PREVIOUSLY ESTABLISHING THAT IF THIS MALFUNCTION WERE TO REOCCUR, A SERIOUS INJURY MAY OCCUR.

    Description of Event or Problem · 1

    DURING A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE, THE DEVICE HAD BEEN INTRODUCED INTO THE PATIENT AND EXPERIENCED A PROBLEM WITH THE HELICAL CABLE. THE DEVICE WAS REMOVED WITHOUT ISSUE AND THE PATIENT HAD NO ADVERSE EFFECTS. DURING THE DEVICE INSPECTION/ EVALUATION, AN UNRELATED PRODUCT PROBLEM WAS DISCOVERED WHICH IF IT WERE TO REOCCUR, COULD CAUSE A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341848 ESOPHYX2 - LINK DESIGN - SHORT ODE ODE ENDOGASTRIC SOLUTIONS, INC R2002 401026

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR