BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 8406876 · Received March 11, 2019

    Report

    Report Number
    8010047-2019-01237
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Date of Event
    January 31, 2019
    Report Date
    April 8, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305177
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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. (OMSC) BUT WAS RETURNED TO OLYMPUS FRANCE (OFR). OFR SENT THE DEVICE TO A THIRD PARTY LABORATORY FOR MICROBIOLOGICAL TESTING. THE ADDITIONAL MICROBIOLOGICAL TESTING INDICATED NO MICROBIAL GROWTH FOR THE ALL CHANNELS OF THE DEVICE. THEREFORE, THE TESTING RESULT CLEARED THE FRENCH GUIDELINE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. 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 MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MULTIPLE MICROBIOLOGICAL TESTING BY THE USER FACILITY, FOLLOWING AMOUNT OF UNSPECIFIED MICROBES WERE DETECTED WITH THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. [FIRST TIME; (B)(6) 2019]: 17 CFU / 100ML, [SECOND TIME; (B)(6) 2019]: 16 CFU / 100ML, [THIRD TIME; (B)(6) 2019]: 16 CFU / 100ML. THE SUBJECT DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, SOLUSCOPE S3/S4, USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200660 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H190I 04953170305177

    Patients

    Seq Age Sex Outcome Treatment
    1