EVIS LUCERA COLONOVIDEOSCOPE
Received Jun 20, 2026 · Event occurred May 15, 2026
Report 9610595-2026-50283 · MDR key 25570366
Device
Product problems
- Corroded
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE REPAIR TECHNICIAN IDENTIFIED THE DEVICE HAD CORRODED AIR WATER DELIVERY NOZZLE. 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 MOST PROBABLE CAUSE OF THE MALFUNCTION IS TRACED TO COMPONENT FAILURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.