VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 18, 2026 · Event occurred Mar 18, 2026
Report 9610773-2026-03827 · MDR key 25211657
Device
Product problems
- Poor Quality Image
Patient
NA · Unknown
- 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, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE SHADOW IN FRONT OF THE LENS WAS CAUSED BY A COMPONENT FAILURE OF THE CHARGED COUPLED DEVICE OBJECTIVE LENS. 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
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE HAD A SHADOW IN FRONT OF THE LENS. THERE WAS NO PATIENT INVOLVEMENT.