BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1021587 · Received March 25, 2008

    Report

    Report Number
    8010047-2008-00053
    Event Type
    Malfunction
    Date Received
    March 25, 2008
    Date of Event
    February 21, 2008
    Report Date
    February 27, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OLYMPUS ENDOSCOPE AND NON-OLYMPUS STENT INTRODUCER WERE NOT RETURNED TO OLYMPUS FOR INVESTIGATION. THE SOURCE OF THE STENT INTRODUCER CANNOT BE CONCLUSIVELY DETERMINED. IF SIGNIFICANT ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL FOLLOW. THIS REPORT IS BEING FILED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN ATTEMPTED TO INSERT A SPHINCTEROTOME INTO AN OLYMPUS ENDOSCOPE AND AN OBJECT DISLODGED FROM THE INSTRUMENT CHANNEL AND FELL INSIDE OF THE PT. THE OBJECT WAS IMMEDIATELY REMOVED AND IDENTIFIED AS A NON-OLYMPUS STENT INTRODUCER. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND THERE WAS NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK