BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 8792346 · Received July 16, 2019

    Report

    Report Number
    8010047-2019-02543
    Event Type
    Malfunction
    Date Received
    July 16, 2019
    Date of Event
    June 20, 2019
    Report Date
    July 16, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT GIF-HQ290 WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) . THE USER WILL NOT RETURN THE SUBJECT GIF-HQ290. OMSC CHECKED THE MANUFACTURE HISTORY OF THE SUBJECT GIF-HQ290, THERE WAS NO IRREGULARITY FOUND. THE USER CONTINUES TO USE THE SUBJECT GIF-HQ290. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    DURING A PROCEDURE OF ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE ERROR MESSAGE B30 (SCOPE COMMUNICATION ERROR) WAS DISPLAYED ON THE MONITOR WHEN ARGON PLASMA COAGULATION DEVICE WAS BEING ACTIVATED. THE USER REPLACED THE SUBJECT GIF-HQ290 WITH A SIMILAR DEVICE AND COMPLETED THE PROCEDURE. ACCORDING TO INSPECTION BY THE USER AFTER THE COMPLETION OF PROCEDURE, THE ERROR MESSAGE DIDN'T RECUR. THERE WAS NO REPORT OF THE PATIENT¿S INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586621 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-HQ290

    Patients

    Seq Age Sex Outcome Treatment
    1