BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 9259539 · Received October 31, 2019

    Report

    Report Number
    8010047-2019-03778
    Event Type
    Injury
    Date Received
    October 31, 2019
    Date of Event
    October 7, 2019
    Report Date
    October 31, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPRESENTATIVE OF OLYMPUS MEDICAL SCIENCE SALES CO.,LTD. VISITED THE USER FACILITY TO PERFORM VISUAL INSPECTION ON THE TWO GIF-XP290NS AND REVIEW THE REPROCESSING PROCESS. THERE WAS NO SIGNIFICANT DAMAGE OR STAINS THE TWO SCOPES. IN ADDITION, THERE WERE NO DEVIATIONS OF REPROCESSING PROCESS AT THE USER FACILITY. THE TWO GIF-XP290NS WERE RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC EVALUATED TWO GIF-XP290NS AND CONFIRMED THAT THERE WAS NO IRREGULARITY IN TWO GIF-XP290NS. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF TWO GIF-XP290N (S/N (B)(4) ) AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT TWO PATIENTS COMPLAINED OF VOMITING AND ABDOMINAL PAIN AFTER UPPER ENDOSCOPY USING THE OLYMPUS GASTROINTESTINALSCOPE (GIF-XP290N). THEREFORE, THE USER FACILITY ASKED OLYMPUS TO INVESTIGATE THE DEVICE. IT WAS REPORTED THAT THE USER FACILITY POSSESSED TWO GIF-XP290N (S/N (B)(4)), BUT IT WAS NOT SURE WHICH DEVICE WAS USED FOR WHICH PATIENT. THE USER FACILITY MENTIONED THAT PATIENTS SOMETIMES FEEL UNCOMFORTABLE WHEN AN ENDOSCOPE FEEDS AIR TO STOMACH. THE USER FACILITY HAD MANUALLY CLEANED THE TWO GIF-XP290NS USING AN OLYMPUS CLEANING BRUSH AND HIGH LEVEL DISINFECTED THE TWO GIF-XP290NS USING A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR (KD-01, KAIGEN), USING A STRONGLY ACIDIC ELECTROLYSIS WATER. OMSC IS SUBMITTING TWO MEDICAL DEVICE REPORTS ACCORDING TO THE NUMBER OF THE PATIENTS. THIS IS TWO OF TWO REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058769 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-XP290N

    Patients

    Seq Age Sex Outcome Treatment
    1 Other