BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 7145436 · Received December 26, 2017

    Report

    Report Number
    8010047-2017-02093
    Event Type
    Malfunction
    Date Received
    December 26, 2017
    Date of Event
    November 23, 2017
    Report Date
    February 25, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS SUBMITTING TO CORRECT "DEVICE PRODUCT CODE" AND "PMA/510(K) NUMBER".

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE AIR/WATER CHANNEL OF THE SUBJECT DEVICE TESTED POSITIVE FOR PSEUDOMONAS PUTIDA (1CFU/CHANNEL). THE TEST RESULT CLEARED THE (B)(4) GUIDELINE. THE SUBJECT DEVICE HAD BEEN DISINFECTED USING AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL ETD3 (NOT AVAILABLE IN THE U.S.) WITH PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924848 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H190

    Patients

    Seq Age Sex Outcome Treatment
    1