BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 1492419 · Received September 29, 2009

    Report

    Report Number
    8010047-2009-00181
    Event Type
    Other
    Date Received
    September 29, 2009
    Report Date
    September 3, 2009
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY AND WAS INFORMED THAT THE USER FACILITY HAS NOT BEEN MANUALLY CLEANING THE ELEVATOR WIRE CHANNEL OF THE DEVICE IN ACCORDANCE WITH THE DEVICE INSTRUCTION MANUAL SINCE THE TIME THE DEVICE WAS INITIALLY PURCHASED IN 2004. THE USER FACILITY REPORTED THAT THEY WERE INCORRECTLY INSTRUCTED BY THEIR THIRD PARTY SERVICE COMPANY ON ENDOSCOPE REPROCESSING. THE USER FACILITY ELECTED NOT TO RETURN THIS DEVICE TO OLYMPUS TO EVALUATION. BASED ON THE INFORMATION PROVIDED BY THE USER FACILITY, THE CAUSE OF THE REPORTED PHENOMENON APPEARS TO BE DUE TO INADEQUATE REPROCESSING. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST HAS VISITED THE USER FACILITY TO PROVIDE IN-SERVICE TRAINING ON HOW TO APPROPRIATELY REPROCESS THE DEVICE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    DURING A VISIT TO THE USER FACILITY, HOSPITAL STAFF REPORTED TO HAVE FOUND BILE-LIKE FLUID ON THE GROUND BENEATH WHERE THE SUBJECT ENDOSCOPE WAS HUNG FOLLOWING REPROCESSING. THE USER FACILITY STATED THERE HAVE BEEN NO REPORTS OF PATIENT CROSS-EXAMINATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1