VISERA PRO XENON LIGHT SOURCE

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, THE MOST PROBABLE CAUSE OF THE COMPLAINT WAS 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 DURING DEVICE EVALUATION THAT THE XENON LIGHT SOURCE EXHIBITED FRONT PANEL BLINKING, MAIN BOARD FAILURE, DIMMING OF THE EMERGENCY LIGHT, AND EMERGENCY LIGHT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.