BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 7463632 · Received April 26, 2018

    Report

    Report Number
    8010047-2018-00769
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    March 27, 2018
    Report Date
    April 26, 2018
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    PK143153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. OMSC REVIEWED THE MANUFACTURE HISTORY OF THE 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 MICROBES WERE DETECTED FROM THE SUBJECT DEVICE. [FIRST TIME; (B)(6) 2018] ENTEROBACTER COMPLEXE CLOACAE (>100 CFU /100 ML), PSEUDOMONAS AERUGINOSA (>100 CFU /100 ML). [SECOND TIME; (B)(6) 2018], NO MICROORGANISMS GROWTH. [THIRD TIME; (B)(6) 2018], ESCHERICHIA COLI (>100 CFU /100 ML), PSEUDOMONAS AERUGINOSA (54 CFU /100 ML). THERE WAS NO INFORMATION WHERE THESE SAMPLES WERE COLLECTED FROM THE SUBJECT DEVICE. THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, SOLUSCOPE 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
    310181 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q180V

    Patients

    Seq Age Sex Outcome Treatment
    1