BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 8127360 · Received December 3, 2018

    Report

    Report Number
    8010047-2018-02353
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    November 6, 2018
    Report Date
    October 8, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS SUBMITTING TO CORRECT "DEVICE PRODUCT CODE".

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE USER FACILITY CONDUCTED THE SECOND MICROBIOLOGICAL TESTING AFTER CAREFULLY REPROCESSING THE SUBJECT DEVICE. AS A RESULT OF THE SECOND MICROBIOLOGICAL TESTING, NO MICROBE WAS DETECTED FROM THE SUBJECT DEVICE. 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

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. AS PART OF OUR INVESTIGATION, OMSC ASKED THE USER FACILITY TO CHECK THEIR REPROCESSING PRACTICE ACCORDING TO OMSC¿S CHECKLIST. OMSC CONFIRMED ONE DEVIATION FROM THE INSTRUCTION MANUAL OF THE DEVICE THAT THE DISINFECTANT SOLUTION WAS LESS THAN EFFECTIVE CONCENTRATION. 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 THAT AS A RESULT OF THE MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SAMPLE COLLECTED FROM THE AUXILIARY WATER CHANNEL AND THE ELEVATOR WIRE CHANNEL OF THE SUBJECT DEVICE TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA. IT WAS THE FIRST TIME FOR ULTRASOUND GASTRO SCOPES TO CONDUCT MICROBIOLOGICAL TESTING AT THE USER FACILITY. THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, ENDOCLENS (JOHNSON AND JOHNSON), USING ORTHO-PHTHALALDEHYDE (DISOPA PRODUCED BY JOHNSON AND JOHNSON). THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT. THE USER FACILITY HAS DECIDED NOT TO PLAN PATIENTS RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962965 EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT260

    Patients

    Seq Age Sex Outcome Treatment
    1