BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHYX2 - LINK DESIGN - SHORT

    MDR report key: 3027496 · Received March 29, 2013

    Report

    Report Number
    3005473391-2013-00076
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 2, 2013
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    PMA / PMN Number
    K092400
    Removal / Correction Number
    3005473391-04/17/13-001-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER? THE HOSPITAL IS SENDING THE DEVICE TO A 3RD PARTY REVIEWER. NO RESULTS HAVE BEEN GIVEN AS THE EVALUATION HAS NOT STARTED. A SUPPLEMENT REPORT WILL BE FILED UPON COMPLETION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION 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.

    Description of Event or Problem · 1

    DURING THE START OF A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE AND AFTER A SUCCESSFUL DEVICE INTRODUCTION INTO THE STOMACH, THE PHYSICIAN WAS UNABLE TO MANIPULATE THE TISSUE MOLD AFTER CLOSING IT. THE TISSUE MOLD WAS STUCK IN THE SEMI-CLOSED POSITION. THE SURGEON SPENT APPROXIMATELY AN HOUR ATTEMPTING TO GET THE TISSUE MOLD TO MOVE IN EITHER DIRECTION WITHOUT ANY SUCCESS. IT WAS THEN DECIDED TO PERFORM AN EXPLORATORY LAPAROTOMY AND ATTEMPT TO OPEN THE TISSUE MOLD. A FOUR INCH INCISION WAS MADE AND THE SURGEON WAS ABLE TO MANIPULATE THE TISSUE MOLD TO AN OPEN POSITION, USING HIS HAND FROM OUTSIDE OF THE STOMACH. IT WAS IMMEDIATELY SUCCESSFUL AND THE TISSUE MOLD MOVED WITH NO RESISTANCE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS NOT PERFORMED. THE PATIENT REMAINED HOSPITALIZED FOR 5 DAYS AND HAS BEEN DISCHARGED.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130348 ESOPHYX2 - LINK DESIGN - SHORT ODE ODE ENDOGASTRIC SOLUTIONS, INC R2002 401026

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R