VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jun 6, 2026 · Event occurred May 20, 2026
Report 9610773-2026-04300 · MDR key 25419050
Device
Product problems
- Erratic or Intermittent Display
- Communication or Transmission Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED IMAGE FLICKERS IN COLORFUL HUES AND SCOPE ERROR (E226) INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT PRESENTS THE RESULTS OF THE FINAL INVESTIGATION. THE FOLLOWING FIELDS HAVE BEEN UPDATED: D8, D9, H2, H3, H6, AND H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION; HOWEVER, THE REPORTED FAILURE COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. AS THE DEVICE MALFUNCTION WAS NOT CONFIRMED DURING EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE REMAINS UNDETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR THE DEVICE'S PERFORMANCE IN THE FIELD.
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.