OES CHOLEDOCHO FIBERSCOPE

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION AND PREVIOUS INVESTIGATIONS THROUGH THE PRODUCT TECHNICAL INVESTIGATION (PTI) PROCESS, REASONABLY KNOWN INFORMATION SUGGESTS PROBABLE CAUSES DUE TO SOME KIND OF STRESS SUCH AS DAMAGE OR DETERIORATION OF PARTS AND MECHANICAL ISSUES SUCH AS LEAKAGE/SEAL, DAMAGE, DETERIORATION, AND WEAR AND TEAR. 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 THAT DURING THE DEVICE EVALUATION, THE CHOLEDOCHO FIBERSCOPE EXHIBITED THE DISTAL END COVER WAS MISSING AND THE SUCTION PORT HAD RUST STAINS. THERE WAS NO PATIENT INVOLVEMENT.