EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE
Received Jul 31, 2026 · Event occurred Jan 9, 2026
Report 9610595-2026-61782 · MDR key 50097813
Device
Product problems
- No Display/Image
- Communication or Transmission Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
The customer returned the gastrointestinal videoscope to the service center for a separate issue. During the device analysis the Technical Assistance Center (TAC) Representative indicates that scope error code E315 was found and no image was displayed. 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 following led to the malfunction: failures are related to scope connector liquid immersion and degradation.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.