MalfunctionFDF
EVIS LUCERA ELITE COLONOVIDEOSCOPE
Received Jul 31, 2026 · Event occurred Jul 20, 2026
Report 9610595-2026-61951 · MDR key 50101578
Device
Product problems
- No Display/Image
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
The customer reported the Olympus Colonovideoscope had a blackout during inspection for use. There were no reports of patient involvement.
Additional Manufacturer Narrative
The device evaluation is ongoing. Should additional relevant information become available, a supplemental report will be submitted.E1 - Address: (b)(6).