OES CHOLEDOCHO FIBERSCOPE

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, AND ALTHOUGH WE COULD NOT SPECIFY THE ROOT CAUSE OF THE SUGGESTED EVENT, IT IS LIKELY THE DEFECT WAS CAUSED BY SOME KIND OF STRESS, SUCH AS DAMAGE OR DETERIORATION OF PARTS. THE MOST PROBABLE CAUSE OF THIS COMPLAINT IS EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THERE WAS CRYSTALLIZATION INSIDE THE LIGHT GUIDE ROD OF THE FIBERSCOPE. THERE WAS NO PATIENT INVOLVEMENT.