EVIS LUCERA ELITE XENON LIGHT SOURCE
Received Jul 8, 2026 · Event occurred Apr 20, 2026
Report 3002808148-2026-23272 · MDR key 25757514
Device
Product problems
- Corroded
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
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 INDICATES THAT AN INTERNAL FLUID INGRESS AND CORROSION WAS FOUND. 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, IT IS LIKELY THAT THE MALFUNCTION WAS CAUSED BY INTERNAL FLUID INGRESS AND CORROSION. 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.