EVIS LUCERA COLONOVIDEOSCOPE
Received Jul 15, 2026 · Event occurred Apr 16, 2026
Report 9610595-2026-56985 · MDR key 25829772
Device
Product problems
- Failure to Clean Adequately
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
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. THE MOST PROBABLE CAUSE OF THE COMPLAINT IS CAUSE NOT ESTABLISHED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE TEAM INDICATES THAT CRYSTALLIZATION IN BOTH THE CONTROL UNIT AND THE OPTICAL WAVEGUIDE ROD AND WATER SCALE BUILDUP UNDER THE OPTICAL WAVEGUIDE LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.