EVIS LUCERA COLONOVIDEOSCOPE
Received Jun 29, 2026 · Event occurred May 20, 2026
Report 9610595-2026-52743 · MDR key 25652282
Device
Product problems
- Failure to Clean Adequately
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 A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT FOREIGN OBJECTS IN AUXILIARY JET TUBE WERE FOUND. 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 COULD NOT BE ESTABLISHED. THE LEGAL MANUFACTURE REVIEWED THE CUSTOMER PROVIDED THE CLEANING DISINFECTION AND STERILIZATION (CDS) PROCESSES WHERE NO OBVIOUS DEVIATIONS FROM INSTRUCTIONS FOR USE (IFU) WERE IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.