BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1053461 · Received May 28, 2008

    Report

    Report Number
    8010047-2008-00094
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Report Date
    April 28, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION FOUND THE KNIFE WIRE DETACHED FROM THE DISTAL END SIDE OF THE DEVICE. THERE WAS NO EVIDENCE OF THERMAL DAMAGE NOTED ON THE DEVICE. THE CAUSE OF THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. THE DEVICE WAS RECOVERED AND SENT TO THE ORIGINAL EQUIPMENT MFR FOR FURTHER INVESTIGATION. IF SIGNIFICANT ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED. THIS REPORT IS BEING FILED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE WIRE SNAPPED. THE PROCEDURE WAS REPORTEDLY COMPLETED WITH A DIFFERENT, BUT SIMILAR DEVICE AND THERE WAS NO PT INJURY. THE USER FACILITY WAS CONTACTED FOR ADDITIONAL INFO, BUT WAS UNABLE TO PROVIDE FURTHER DETAILS REGARDING THE CIRCUMSTANCES IN WHICH THE REPORTED DIFFICULTY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS TRIPLE LUMEN SPHINCTEROTOME FDR OLYMPUS MEDICAL SYSTEMS CORPORATION KD-V411M-0 81K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK