BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 7730209 · Received July 29, 2018

    Report

    Report Number
    8010047-2018-01480
    Event Type
    Malfunction
    Date Received
    July 29, 2018
    Date of Event
    June 26, 2018
    Report Date
    July 30, 2018
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170367311
    PMA / PMN Number
    K143153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. BUT WAS RETURNED TO OLYMPUS (B)(4). THE SUBJECT DEVICE WAS SENT TO A THIRD PARTY LABORATORY FOR ADDITIONAL MICROBIOLOGICAL TESTING. IN THE ADDITIONAL TEST, THE TEST RESULT INDICATED NO MICROBIAL GROWTH FOR THE SUBJECT DEVICE. OMSC REVIEWED THE MANUFACTURE 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 THE SUBJECT DEVICE TESTED POSITIVE FOR BURKHOLDERIA CEPACIA, ESCHERICHIA COLI, KLEBSIELLA PNEUMONIAE SPP. AND STAPHYLOCOCCUS NON AUREUS (>100CFU/ENDOSCOPE IN TOTAL) DURING A ROUTINE SURVEILLANCE CULTURING TEST AT THE FACILITY. IT WAS REPORTED THAT THE USER FACILITY HAD REPROCESSED USING A NON-OLYMPUS ENDOSCOPE REPROCESSOR (SOLUSUCOPE S4) WITH PERACETIC ACID. THERE WAS NO REPORT OF PATIENT INFECTION ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572058 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q180V 04953170367311

    Patients

    Seq Age Sex Outcome Treatment
    1