BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS VISERA TRANSNASAL ESOPHAGOVIDEOSCOPE

    MDR report key: 3593285 · Received January 10, 2014

    Report

    Report Number
    2951238-2014-00005
    Event Type
    Other
    Date Received
    January 10, 2014
    Date of Event
    December 18, 2013
    Report Date
    December 18, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE DEVICE INSTRUMENT HISTORY COULD NOT BE REVIEWED DUE TO LACK OF SERIAL NUMBER. THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE REPROCESSING PRACTICES COULD NOT BE RULED OUT AS A CONTRIBUTORY TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED DURING AN IN-SERVICE, BIO-BURDEN WAS OBSERVED IN THE DISTAL END OF THE ESOPHAGOVIDEOSCOPE. IN ADDITION, THE ENDOSCOPY SUPPORT SPECIALIST (ESS) OBSERVED THAT THE USER FACILITY STAFF WAS NOT PERFORMING PRE-CLEANING, USING HAND SOAP DURING MANUAL CLEANING, AND NOT BRUSHING THE ENTIRE SUCTION CHANNEL. ALSO, THE USER FACILITY WAS NOT FOLLOWING THE RECOMMENDED SOAKING TIME IN THE DISINFECTANT SOLUTION AND NOT COMPLETELY SUBMERGING THE ESOPHAGOVIDEOSCOPE. OLYMPUS CLEANING RECOMMENDATIONS WERE PROVIDED TO THE USER FACILITY. NO PT INFECTION OR CROSS-CONTAMINATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20618 OLYMPUS VISERA TRANSNASAL ESOPHAGOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEM CORPORATION PEF-V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other