BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA ¿ COLONOVIDEOSCOPE

    MDR report key: 8183499 · Received December 20, 2018

    Report

    Report Number
    8010047-2018-02485
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    October 23, 2018
    Report Date
    December 20, 2018
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170202537
    PMA / PMN Number
    K001241
    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 OMSC BUT WAS RETURNED TO OLYMPUS (B)(4). (B)(4) SENT THE SUBJECT DEVICE TO A THIRD PARTY LABORATORY FOR MICROBIOLOGICAL TESTING. AS A RESULT OF THE TESTING, THE SAMPLE COLLECTED FROM ALL CHANNELS OF THE DEVICE TESTED POSITIVE FOR UNSPECIFIED MICROBES (1CFU/ENDOSCOPE). THE TESTING RESULT CLEARED THE (B)(6) GUIDELINE. OMSC REVIEWED THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. 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 WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SUBJECT DEVICE TESTED POSITIVE FOR THE FOLLOWING BACTERIA. ON (B)(6) 2018: TOTAL: PSEUDOMONAS SPP. (>100CFU) AND PSEUDOMONAS AERUGINOSA (>100CFU). ON (B)(6) 2018: TOTAL: UNSPECIFIED BACTERIA (27CFU). THE PORTION OF THE SUBJECT DEVICE, WHERE THE MICROBES WERE DETECTED, WERE NOT REPORTED. THE SUBJECT DEVICE HAD BEEN BRUSHED MANUALLY USING A NON-OLYMPUS CLEANING BRUSH (PRINCE MEDICAL, ANIOS CLEAN) AND DISINFECTED USING NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR (SOLUSCOPE, SERIES4) WITH PERACETIC ACID. THERE WAS NO REPORT OF PATIENT INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027635 EVIS EXERA ¿ COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-Q165I 04953170202537

    Patients

    Seq Age Sex Outcome Treatment
    1