EVIS LUCERA ELITE XENON LIGHT SOURCE
Received May 22, 2026 · Event occurred Mar 12, 2026
Report 3002808148-2026-17566 · MDR key 25261085
Device
Product problems
- Erratic or Intermittent Display
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE XENON LIGHT SOURCE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF ERROR CODE E202. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING DEVICE INSPECTION, THE SCREEN WAS OBSERVED TO EXHIBIT INTERMITTENT NOISE. 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 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.