BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERO-RENO VIDEOSCOPE

    MDR report key: 6986351 · Received October 30, 2017

    Report

    Report Number
    8010047-2017-01584
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Date of Event
    September 8, 2017
    Report Date
    November 24, 2017
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    PK072957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. AS A RESULT OF INVESTIGATION, IT WAS FOUND THAT THE SUBJECT DEVICE HAD BEEN MANUALLY REPROCESSED USING SALVANIOS PH10 AS A DETERGENT AND ANIOXY TWIN AS A DISINFECTANT AT THE USER FACILITY.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS (B)(4). OLYMPUS (B)(4) SENT THE SUBJECT DEVICE TO A THIRD PARTY LABORATORY FOR MICROBIOLOGICAL TESTING AND THE TESTING INDICATED NO MICROORGANISMS GROWTH FOR THE SUBJECT DEVICE. THE EXACT CAUSE COULD NOT BE DETERMINED AT PRESENT, IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THREE TIMES OF SURVEILLANCE CULTURING TEST AT THE USER FACILITY, THE SUBJECT DEVICE TESTED POSITIVE FOR THE FOLLOWING SOME KINDS OF BACTERIA. FIRST TIME: BACILLUS SPP. MESOPHILES(2CFU/ENDOSCOPE), CORYNEBACTERIUM SPECIES(5CFU/ENDOSCOPE), MICROCOCCACEAE(2CFU/ENDOSCOPE), SECOND TIME: MICROCOCCACEAE(2CFU/ENDOSCOPE), THIRD TIME: STAPHYLOCOCCUS COAGULASE NEGATIVE(8CFU/ENDOSCOPE). THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765999 URETERO-RENO VIDEOSCOPE URETERO-RENO VIDEOSCOPE FGB OLYMPUS MEDICAL SYSTEMS CORP. URF-V2

    Patients

    Seq Age Sex Outcome Treatment
    1