BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS ENDOSCOPE REPROCESSOR

    MDR report key: 2161127 · Received July 6, 2011

    Report

    Report Number
    8010047-2011-00145
    Event Type
    Other
    Date Received
    July 6, 2011
    Date of Event
    April 27, 2011
    Report Date
    June 7, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THIS REPORT. AFTER THE EVENT, IT WAS OBSERVED THAT ONE END OF A (B)(4) CONNECTING TUBE WAS HANGING OUTSIDE OF THE REPROCESSOR AND THE DISTAL END OF THE CONNECTING TUBE WAS NOT CONNECTED TO AN ENDOSCOPE. THE CONNECTING TUBE WAS SAID TO BE CONNECTED TO THE PORT IN THE BASIN, AND WAS PINCHED BETWEEN THE WASHER DOOR AND INSULATION AT TOP OF THE DEVICE, AND WAS HANGING ABOVE THE POWER OUTLET. FLUID WAS SAID TO BE OBSERVED ON THE FLOOR. THE USER FACILITY INDICATED THAT THEY WERE AWARE THAT THE CONNECTING TUBE SHOULD NOT BE USED IF NO ENDOSCOPE WAS TO BE PLACED IN THE BASIN, AND THAT THIS APPEARED TO BE A CASE OF USER ERROR. THERE WAS REPORTEDLY NO DAMAGE DONE TO THE DEPARTMENT, AND THE LIMITED SMOKE WAS RESOLVED WITH EXHAUST FANS, AND PROCEDURES RESUMED THE SAME DAY. ONE OF THE PATIENTS TRANSPORTED TO RECOVERY HAD THE PROCEDURE COMPLETED THE SAME DAY. THE SECOND PT HAD JUST COMPLETED THE PROCEDURE AT THE TIME OF THE EVENT, THEREFORE NO FURTHER PROCEDURE TIME WAS REQUIRED. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVAL. 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 A SMALL FIRE HAD OCCURRED IN AN ELECTRICAL OUTLET IN THE ENDOSCOPE REPROCESSING ROOM. SMOKE WAS OBSERVED TO EMIT FROM THE UPPER ELECTRICAL CONNECTOR AND FLAMES WERE REPORTEDLY OBSERVED COMING FROM THE LOWER ELECTRICAL CONNECTOR IN THE OUTLET. TWO PTS WERE REMOVED FROM PROCEDURES IN OTHER ROOMS, AND TRANSPORTED TO RECOVERY ROOMS, AND THE LOCAL FIRE RESPONSE TEAM AND FIRE DEPARTMENT WERE SUMMONED. THE FIRE WAS QUICKLY EXTINGUISHED. THERE WAS NO HARM TO PTS, USERS, OR FIRE PERSONNEL, HOWEVER, A PT IN THE WAITING ROOM WAS SAID TO HAVE COLLAPSED DUE TO AN UNRELATED MATTER AT ABOUT THE TIME OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ENDOSCOPE REPROCESSOR ENDOSCOPE REPROCESSOR FEB OLYMPUS MEDICAL SYSTEMS CORPORATION OER-PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other