BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 3033159 · Received March 1, 2013

    Report

    Report Number
    8010047-2013-00070
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 7, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THE REPORTED EVENT, AND WAS INFORMED THAT THE SUBJECT DEVICE WAS USED DURING IN ERCP. THE USER WAS ATTEMPTING TO DEPLOY A BOSTON SCIENTIFIC FLEXIMA STENT, MODEL/LOT UNK, INTO THE COMMON BILE DUCT, ENCOUNTERED RESISTANCE AND REPEATED ATTEMPTS CAUSED THE FORCEPS ELEVATOR TO STOP FUNCTIONING. THE USER SWITCHED TO A DIFFERENT BUT SIMILAR DEVICE BUT WAS NOT ABLE TO DEPLOY THE STENT INTO THE PT'S COMMON BILE DUCT. THE PT WAS TRANSFERRED TO RADIOLOGY TO HAVE THE STENT PLACED PERCUTANEOUSLY WITH THE USE OF X-RAYS. THERE WAS NO REPORT OF PT INJURY. NO FURTHER INFO WAS PROVIDED. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE FORCEPS ELEVATOR MECHANISM OF THE DEVICE WAS NOT WORKING DUE TO A BROKEN WIRE STOPPER. IN ADDITION, THE DEVICE FAILED THE LEAK TEST DUE TO A HOLE/CUT IN THE BENDING SECTION DISTAL END COVER. THE DEVICE WAS SERVICED AND RETURNED TO THE USER FACILITY. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED, BUT THE USE OF A NON-OLYMPUS STENT COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR.

    Description of Event or Problem · 1

    OLYMPUS WAS NOTIFIED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE ELEVATOR CHANNEL BROKE ON THE SUBJECT DEVICE, WHILE THE USER WAS PLACING A STENT. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90233 OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE KOG OLYMPUS MEDICAL SYSTEMS CORPORATION TJF-160F NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BOSTON SCIENTIFIC FLEXIMA STENT