BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOMAXX ESOPHAGEAL STENT

    MDR report key: 4190037 · Received September 18, 2014

    Report

    Report Number
    1721504-2014-00217
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    July 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    ESW
    PMA / PMN Number
    K111611
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: NO DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. SINCE THE LOT NUMBER WAS NOT PROVIDED, THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED. BECAUSE THE UNIT WAS NOT RETURNED, THE ROOT CAUSE COULD NOT BE DETERMINED. IF THE DEVICE IS RETURNED IN THE FUTURE THIS INVESTIGATION WILL BE REOPENED AND AN ADDITIONAL FOLLOW UP SUBMITTED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT AN ESOPHAGEAL STENT BROKE INTO TWO PIECES DURING A ROUTINE REMOVAL. THE STENT WAS CAUGHT ON THE UPPER ESOPHAGEAL SPHINCTER DURING REMOVAL. NO IMPLANT DATE OR LOT NUMBER WAS PROVIDED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577671 ENDOMAXX ESOPHAGEAL STENT PROSTHESIS, ESPHAGEAL ESW MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1