BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1073708 · Received July 1, 2008

    Report

    Report Number
    8010047-2008-00116
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Report Date
    June 5, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENDOSCOPE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION NOTED THE PRESENCE OF TECH AT THE BASE OF THE FORCEPS ELEVATOR, WHICH MAY HAVE CAUSED THE USER'S EXPERIENCE. THE SOURCE OF THE DAMAGE COULD NOT BE DETERMINED. THE ENDOSCOPE WAS SENT TO THE ORIGINAL EQUIPMENT MANUFACTURER FOR FURTHER INVESTIGATION. IF SIGNIFICANT, ADDITIONAL INFORMATION 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 THREE THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHIES, THE FORCEPS ELEVATOR OF THE ENDOSCOPE TORE THE NON-OLYMPUS BALLOONS AND SPHINCTEROTOMES UTILIZED WITH THE ENDOSCOPE. THE PROCEDURES WERE REPORTEDLY COMPLETED WITH THE SAME ENDOSCOPE, BUT WITH OTHER NON-OLYMPUS BALLOONS AND SPHINCTEROTOMES. THE USER FACILITY REPORTED THERE WERE NO PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS DUODENOVIDEOSCOPE FAK OLYMPUS MEDICAL SYSTEMS CORPORATION TJF-140F NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK