EVIS LUCERA ELITE XENON LIGHT SOURCE
Received Apr 24, 2026 · Event occurred Apr 16, 2026
Report 3002808148-2026-13144 · MDR key 24987919
Device
Product problems
- No Display/Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD NO IMAGE DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D9, H2, H3, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE MALFUNCTION DUE TO POOR CONTACT OF SCOPE SOCKET AND FAILURE IN CIRCUIT (EX) BOARD. 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
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.