EVIS LUCERA COLONOVIDEOSCOPE
Received Jul 3, 2026 · Event occurred May 25, 2026
Report 9610595-2026-54079 · MDR key 25704129
Device
Product problems
- Failure to Clean Adequately
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE COMPLAINT WAS 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 COLONOSCOPE TO THE SERVICE CENTER, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT, NOZZLE HAS FOREIGN OBJECTS. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE COMPLAINT COULD NOT BE ESTABLISHED. THERE WAS NO PATIENT INVOLVEMENT.