BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS EVIS DUODENOVIDEOSCOPE

    MDR report key: 1508417 · Received October 13, 2009

    Report

    Report Number
    8010047-2009-00191
    Event Type
    Other
    Date Received
    October 13, 2009
    Report Date
    September 15, 2009
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS HAD FOLLOWED-UP WITH THE USER FACILITY TO GATHER ADD'L INFO REGARDING THE EVENT BUT THE USER FACILITY PROVIDED ONLY LIMITED INFO. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL COULD NOT CONFIRM THE REPORT FROM THE USER FACILITY. THE INSTRUMENT CHANNEL WAS EXAMINED, AND THERE WERE NO SCRAPES OR TEARS PRESENT. THERE WAS NO EVIDENCE OF A STENT INSIDE THE INSTRUMENT CHANNEL. THE ENDOSCOPE INSERTION TUBE, INSTRUMENT CHANNEL, SUCTION CHANNEL, DISTAL END COVER, BENDING SECTION, AND BENDING SECTION CEMENT WERE ALL DETERMINED TO BE NON-OLYMPUS PARTS. THE BRUSH PASSAGE WAS NOTED TO BE RESTRICTED DUE TO A KINK IN SUCTION CHANNEL BELOW THE ENDOSCOPE CONNECTOR BOOT. THE CAUSE OF THE USER'S EXPERIENCE COULD NOT CONCLUSIVELY BE DETERMINED. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST HAS BEEN DISPATCHED TO THE USER FACILITY TO CONDUCT AN IN-SERVICE TRAINING AS NEEDED. IF ADD'L SIGNIFICANT INFO BECOMES AVAILABLE, THE REPORT WILL BE UPDATED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A COOK METAL STENT WAS REPORTEDLY RETRIEVED FROM INSIDE THE BIOPSY CHANNEL. NO METAL STENT HAD BEEN USED DURING THE PROCEDURE. THE SUBJECT DEVICE WAS SAID TO HAVE GONE THROUGH SEVERAL REPROCESSINGS BEFORE THE REPORTED EVENT. THE PROCEDURE WAS REPORTEDLY COMPLETED WITH THE SAME ENDOSCOPE. THERE WAS NO PT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other