HALOGEN LIGHT SOURCE

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: TEMPERATURE FUSE MALFUNCTION CAUSING LIGHT SOURCE MALFUNCTION THE MOST PROBABLE CAUSE OF THE COMPLAINT/FAILURE IS CAUSE TRACED TO COMPONENT FAILURE. 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 HALOGEN LIGHT SOURCE EXHIBITED TEMPERATURE FUSE MALFUNCTION CAUSING LIGHT SOURCE MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT.