BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 9961462 · Received April 15, 2020

    Report

    Report Number
    8010047-2020-02211
    Event Type
    Malfunction
    Date Received
    April 15, 2020
    Date of Event
    March 20, 2020
    Report Date
    May 28, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    UDI-DI
    04953170341809
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS AUSTRALIA (OAZ). OAZ DID NOT SEND THE DEVICE TO A THIRD PARTY LABORATORY FOR MICROBIOLOGICAL TESTING. OAZ CHECKED THE SUBJECT DEVICE AND FOUND THE DAMAGE OF THE DISTAL END AND THE ANGULATION FAILURE. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. 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 MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SUBJECT DEVICE TESTED POSITIVE FOR PSEUDOMONAS. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION SUCH AS THE NUMBER OF MICROBES OR THE REPROCESSING METHOD. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427188 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170341809

    Patients

    Seq Age Sex Outcome Treatment
    1