EVIS LUCERA ELITE XENON LIGHT SOURCE

Description of Event or Problem

THE CUSTOMER RETURNED THE XENON LIGHT SOURCE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN IDENTIFIED THAT THE DEVICE EXHIBITED A NOISY IMAGE, WHICH WAS DETERMINED TO HAVE BEEN CAUSED BY A FAULTY ALL IN ONE INTERFACE. THERE WAS NO PATIENT INVOLVEMENT.

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 NOISY IMAGE WAS A FAULTY ALL IN ONE INTERFACE. THE CONCLUSION WAS THAT THE ISSUE 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.