MalfunctionFDF
EVIS LUCERA COLONOVIDEOSCOPE
Received Jul 9, 2026 · Event occurred Jun 18, 2026
Report 9610595-2026-55400 · MDR key 25765465
Device
Product problems
- Poor Quality Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED IMAGE NOISE, LIKE A SANDSTORM APPEARED OCCASIONALLY DURING REPROCESSING INVOLVING AN OLYMPUS COLONOVIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Additional Manufacturer Narrative
E1 - INITIAL REPORTER ESTABLISHMENT NAME: (B)(6) HOSPITAL. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.