BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 8251827 · Received January 16, 2019

    Report

    Report Number
    8010047-2019-00864
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Report Date
    April 1, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAJ
    PMA / PMN Number
    K062049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION AND WAS REPORTED THAT THE SUBJECT DEVICE TESTED POSITIVE FOR MICROCOCCUS (1CFU/100ML) DURING THE CULTURING TEST CONDUCTED BY THE USER FACILITY. THE FACILITY ALSO REPORTED THAT THEY HAD CLEANED THE SUBJECT DEVICE USING NON-OLYMPUS CLEANING BRUSH (PRINCE MEDICAL CLEAN MODEL AN 1053018) AND MANUALLY DISINFECTED THE DEVICE WITH PERACETIC ACID. THE EXACT CAUSE COULD NOT BE DETERMINED AT PRESENT. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. BUT WAS RETURNED TO OLYMPUS FRANCE (OFR). THE SUBJECT DEVICE WAS SENT TO A THIRD PARTY LABORATORY FOR ADDITIONAL MICROBIOLOGICAL TESTING. IN THE ADDITIONAL TEST, THE SUBJECT DEVICE TESTED POSITIVE FOR STAPHYLOCOCCUS COAGULASE NEGATIVE (2/CFU/100ML) BUT THE TEST RESULT CLEARED FRENCH GUIDELINCE. THE EXACT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC. OMSC REVIEWED THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. 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 ROUTINE SURVEILLANCE CULTURING TESTS AT THE USER FACILITY, THE SUBJECT DEVICE TESTED POSITIVE FOR UNSPECIFIED BACTERIA. OTHER DETAILED INFORMATION SUCH AS THE TYPE AND NUMBER OF THE BACTERIA HAS NOT BEEN PROVIDED FROM THE USER FACILITY AT PRESENT. THERE WAS NO REPORT OF PATIENT INFECTION ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44458 CYSTO-NEPHRO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE FAJ OLYMPUS MEDICAL SYSTEMS CORP. CYF-VH

    Patients

    Seq Age Sex Outcome Treatment
    1