BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODENOVIDEOSCOPE

    MDR report key: 12230343 · Received July 27, 2021

    Report

    Report Number
    8010047-2021-09385
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    July 1, 2021
    Report Date
    September 21, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170307553
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), THEREFORE OMSC COULD NOT INVESTIGATE THE DEVICE. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. THE DEVICE WAS EVALUATED AT OLYMPUS REPAIR CENTER. OLYMPUS REPAIR CENTER COULD NOT CONFIRM THE MALFUNCTION OF THE DEVICE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. OMSC SURMISED THAT THE USER HANDLING OF THE DEVICE REPROCESSING WAS INAPPROPRIATE. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE FIELD SERVICE ENGINEER VISITED THE USER FACILITY AND REPROCESSED THE DEVICE BY MANUAL WITH IMMERSION IN ORTHO-PHTHALALDEHYDE (OPA) FOR 15 MINUTES. THEN THE FIELD SERVICE ENGINEER TESTED THE DEVICE'S MICROBIOLOGICAL TESTING AND FOUND THAT UNSPECIFIED MICROBES (<10 CFU/ML) WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE DEVICE. THE USER COMMENTED THAT THEY ACCEPTED THE CULTURE TEST RESULT (0-50 CFU/ML). 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 ROUTINE MICROBIOLOGICAL TESTING BY THE USER FACILITY, UNSPECIFIED MICROBES (200 CFU/ML) WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE DEVICE. OTHER DETAILED INFORMATION SUCH AS THE REPROCESSING METHOD WAS NOT PROVIDED. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126799 DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-150 04953170307553

    Patients

    Seq Age Sex Outcome Treatment
    1