EVIS LUCERA ELITE XENON LIGHT SOURCE
Received Jul 28, 2026 · Event occurred Apr 15, 2026
Report 3002808148-2026-25902 · MDR key 50060301
Device
Product problems
- Failure to Clean Adequately
Patient
Unknown
- 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 report technician indicates that residual fluid inside the air pump 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 the most probable cause of the malfunction could not establish. Should additional relevant information become available, a supplemental report will be submitted. Olympus will continue to monitor field performance for this device.