BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 4213570 · Received October 24, 2014

    Report

    Report Number
    2951238-2014-00453
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP
    Product Code
    NWB
    PMA / PMN Number
    K100584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION COULD NOT CONFIRM THE PT'S OUTCOME. THE DEVICE WAS INSPECTED AND NO ABNORMALITIES WERE FOUND. THE DEVICE WAS RETURNED TO THE USER FACILITY. REVIEW OF THE INSTRUMENT HISTORY SHOWED THAT THE DEVICE WAS PURCHASED ON MARCH 4, 2014 AND THIS WAS THE FIRST TIME THE DEVICE WAS RETURNED FOR SERVICE.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT IN THE MIDDLE OF A ESOPHAGOSCOPY GASTROSCOPY DUODENOSCOPY (EGD) PROCEDURE, A CLEANING BRUSH FELL OUT OF THE DEVICE AND INTO THE PT'S STOMACH WHEN THE FORCEPS WERE PASSED THROUGH THE CHANNEL A SECOND TIME. THE CLEANING BRUSH WAS RETRIEVED AND THE INTENDED PROCEDURE WAS COMPLETED WITHIN THE ALLOTTED TIME FRAME. IT WAS REPORTED THAT THE PT' CONDITION WAS GOOD AFTER THE PROCEDURE. THERE WAS NO PT HARM REPORTED. OLYMPUS WAS DISPATCHED A ENDOSCOPY SERVICE SPECIALIST TO THE USER FACILITY TO REVIEW THEIR REPROCESSING PROTOCOLS. AT THIS TIME, NO SCHEDULED DATE HAS BEEN CONFIRMED. IF ADDITIONAL INFORMATION IS AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678577 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROSCOPE NWB OLYMPUS MEDICAL SYSTEMS CORP GIF-H180J NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention