BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 1853629 · Received September 29, 2010

    Report

    Report Number
    8010047-2010-00187
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 31, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FTJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN MORE INFORMATION REGARDING THE REPORT. THE USER FACILITY REPORTED THE PATIENT'S COLON WAS NOT TORTUOUS. ONE OF THE USERS REPORTED THAT THE DEVICE WAS FUNCTIONING PROPERLY OUTSIDE THE PATIENT, BUT WOULD NOT FUNCTION PROPERLY ONCE INSERTED INTO THE PATIENT. THERE WAS NO ADVERSE IMPACT REPORTED TO THE PATIENT. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION FOUND THAT THE ELEVATOR RAISER WOULD NOT LIFT, AND THE ELEVATOR WATER CHANNEL WAS CLOGGED. THE DEVICE HAS BEEN REFURBISHED. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THE ELEVATOR WOULD REPORTEDLY NOT LIFT WHEN MANIPULATED INSIDE THE PATIENT. THE PROCEDURE WAS ABORTED, AS THERE WAS REPORTEDLY NO SPARE DEVICE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FTJ OLYMPUS MEDICAL SYSTEM CORPORATION PJF-160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR