BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 8105249 · Received November 27, 2018

    Report

    Report Number
    8010047-2018-02286
    Event Type
    Malfunction
    Date Received
    November 27, 2018
    Date of Event
    October 25, 2018
    Report Date
    January 9, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170367311
    PMA / PMN Number
    K143153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION RESULT. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS (B)(4). (B)(4) SENT THE DEVICE TO A THIRD PARTY LABORATORY FOR MICROBIOLOGICAL TESTING. AS A RESULT OF THE TESTING, NO MICROBE WAS DETECTED FROM THE SAMPLE COLLECTED FROM ALL CHANNELS OF THE SUBJECT DEVICE. THE TESTING RESULT CLEARED THE (B)(4) 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 IN THIS REPORT 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 ROUTINE MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SAMPLE COLLECTED FROM ALL CHANNELS OF THE SUBJECT DEVICE TESTED POSITIVE FOR ACINETOBACTER CALCOACETIOUS AND PSEUDOMONAS FLUORESCENS / PUTIDA (6 CFU / ENDOSCOPE). THE TESTING RESULT DOES NOT CLEAR THE (B)(6)GUIDELINE. 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
    948509 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q180V 04953170367311

    Patients

    Seq Age Sex Outcome Treatment
    1