BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 7854554 · Received September 7, 2018

    Report

    Report Number
    8010047-2018-01749
    Event Type
    Malfunction
    Date Received
    September 7, 2018
    Date of Event
    August 1, 2018
    Report Date
    February 20, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    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.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS SUBMITTING TO CORRECT "DEVICE PRODUCT CODE".

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC. 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 IS RECEIVED, 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 INSTRUMENT CHANNEL OF THE SUBJECT DEVICE TESTED POSITIVE FOR STENOTROPHOMONAS MALTOPHILIA (2CFU/ENDOSCOPE). THE DEVICE HAD BEEN REPROCESSED WITH NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSORS, SOLUSCOPE S3 AND 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
    695290 EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-160VR

    Patients

    Seq Age Sex Outcome Treatment
    1