EVIS LUCERA ELITE XENON LIGHT SOURCE
Received May 28, 2026 · Event occurred Jan 14, 2026
Report 3002808148-2026-18369 · MDR key 25319747
Device
Product problems
- Erratic or Intermittent Display
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 MALFUNCTION FOUND DURING DEVICE EVALUATION IS 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
THE CUSTOMER RETURNED THE XENON LIGHT SOURCE TO THE SERVICE CENTER FOR A E200. DURING THE DEVICE ANALYSIS, PANEL FLICKERING WAS FOUND. IT WAS DETERMINED THAT THE BOARD NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.