BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1082011 · Received July 21, 2008

    Report

    Report Number
    8010047-2008-00127
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 23, 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 DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE CONTROL KNOB FUNCTIONS WERE REVERSED. THE INSERTION TUBE WAS FOUND TO BE ROTATED AND THE LOCKING RING (S-RING) INSIDE THE PROTECTOR BOOT WAS DETERMINED TO BE LOOSE. A LEAK WAS ALSO NOTED INSIDE THE ELEVATOR K-PIPE FROM THE DISTAL END. BASED UPON THE FINDINGS OF THE INVESTIGATION, IT APPEARS THAT THE S-RING HAD BEEN INSUFFICIENTLY TIGHTENED, AND THE INSERTION TUBE SUBSEQUENTLY ROTATED INTO THE POSITION FOUND WHEN RETURNED FOR EVALUATION. OLYMPUS HAS INITIATED INTERNAL CORRECTIVE ACTIONS TO REDUCE THE LIKELIHOOD OF RECURRENCE OF THIS PHENOMENON. THIS REPORT IS BEING REPORTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIO PANCREATOGRAPHY (ERCP), THE PHYSICIAN REPORTEDLY NOTED THAT THERE WAS SOMETHING WRONG WITH THE ENDOSCOPE, WHICH REPORTEDLY EXTENDED THE LENGTH OF THE PROCEDURE. THE PT WAS SAID TO HAVE EXPERIENCED A RESPIRATORY ARREST, AND THE PROCEDURE WAS NOT COMPLETED. THE PT WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU), AND HAS SUBSEQUENTLY BEEN DISCHARGED, AND IS SAID TO BE DOING FINE. FOLLOWING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE CONTROL KNOB FUNCTIONS WERE REVERSED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization