BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVIS EXERA II THERAPEUTIC VIDEO DUODENOSCOPE

    MDR report key: 2222054 · Received August 18, 2011

    Report

    Report Number
    MW5021820
    Event Type
    Other
    Date Received
    August 18, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 18, 2011
    Manufacturer
    OLYMPUS
    Product Code
    NWB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    DURING USE OF NEW SCOPE UNABLE TO DEPLOY STENT; NOTED ON MONITOR THAT AN OBJECT WAS PROTRUDING WHICH TURNED OUT TO BE A STENT THAT HAD BEEN RETAINED IN THE BARREL, UP AGAINST THE SIDE OF THE BARREL. UNK HOW LONG IT HAD BEEN IN THE BARREL, BUT SCOPE HAD BEEN USED TOTAL OF SIX TIMES. PT 4 WAS (B)(6), AND ALTHOUGH SCOPE HAD BEEN CLEANED AS PER MFR'S DIRECTIONS, EPIDEMIOLOGY FELT THAT VERY REMOTE RISK OF EXPOSURE. PTS 5 OF 6 NOTIFIED AND ARE BEING FOLLOWED BY INFECTIOUS DISEASES SPECIALIST. MESH STENT UP AGAINST THE SIDE OF THE BARREL WAS NOT VISIBLE ON OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVIS EXERA II THERAPEUTIC VIDEO DUODENOSCOPE SIDE VIEWING DUODENOSCOPE NWB OLYMPUS TJF-Q180V

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other BOSTON SCIENTIFIC, CATALOG M00570640. NO SERIAL| WALLFLEX UNCOVERED BILIARY METAL STENT 10MM X 60MM| NUMBER OR MARKING ON STENT WHICH WAS DISCARDED.