BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 10464197 · Received August 28, 2020

    Report

    Report Number
    8010047-2020-05962
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Date of Event
    July 31, 2020
    Report Date
    October 14, 2020
    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 · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE GLOVES WHICH THE USER USED WHEN THE REPORTED PHENOMENON OCCURRED WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR THE EVALUATION. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. OMSC RECEIVED THE GLOVES HAVING THE BROWN COLORED LIQUID WHICH THE USER USED WHEN THE REPORTED PHENOMENON OCCURRED. THOUGH OMSC DID FT-IR (FOURIER TRANSFORM INFRARED SPECTROSCOPY) AND EDX (ENERGY DISPERSIVE X-RAY SPECTROSCOPY) ANALYSIS FOR THAT BROWN COLORED LIQUID, IT COULD NOT BE FOUND AND DETERMINED WHAT COMPONENTS IN THAT LIQUID. OMSC EXTRACTED THE COMPONENTS FROM THE PARTS WHERE HAD PUT THE BROWN COLOR LIQUID AND WHERE HAD NOT PUT THE BROWN COLOR LIQUID WITH PURE WATER, ETHANOL, AND HEXANE. THEN ITS HEATED RESIDUES WERE ANALYZED, BUT IT WAS DETECTED THE ESTER STRONGLY WHICH IS A PART OF GLOVE¿S COMPONENT, NOT DETECTED THE TARGET WHERE THE GLOVE COLOR CHANGED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR THE EVALUATION, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT THE BROWN COLORED LIQUID CAME OUT FROM THE DISTAL END OF THE SUBJECT DEVICE DURING THE MANUALLY CLEANING OF THE SUBJECT DEVICE WITH THE NON-OLYMPUS BRUSH BEFORE THE REPROCESSING USING THE OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL OER-5 (NOT AVAILABLE IN THE USA). AFTER THE SUBJECT DEVICE WAS REPROCESSED WITH THE OER-5, THE BROWN COLORED LIQUID DID NOT COME OUT. ALSO THERE WAS NO INFORMATION THAT THE SUBJECT DEVICE AND THE OER-5 HAD ABNORMAL. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929553 GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-1200N

    Patients

    Seq Age Sex Outcome Treatment
    1