MalfunctionGCT
EVIS LUCERA ELITE XENON LIGHT SOURCE
Received May 12, 2026 · Event occurred Apr 27, 2026
Report 3002808148-2026-15626 · MDR key 25154295
Device
Product problems
- Erratic or Intermittent Display
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE XENON LIGHT SOURCE IMAGE WAS OCCASIONALLY NOT PLAYING. THE ISSUE WAS FOUND DURING INSPECTION FOR USE THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.