BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHYX2 - LINK DESIGN - SHORT

    MDR report key: 2448834 · Received February 13, 2012

    Report

    Report Number
    3005473391-2012-00052
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    January 19, 2012
    Report Date
    January 19, 2012
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    PMA / PMN Number
    K092400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WAS NO INDICATION OF AN INJURY TO THE PATIENT OR A MANUFACTURING PROCESS ISSUE, 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

    AS THE SURGEON INTRODUCED THE DEVICE INTO THE PATIENT, THE SCOPE RETAINER BAND BROKE. THERE WAS NO INJURY TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESOPHYX2 - LINK DESIGN - SHORT ODE ODE ENDOGASTRIC SOLUTIONS, INC R2002 401115

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR