VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jun 3, 2026 · Event occurred Mar 6, 2026
Report 9610773-2026-04238 · MDR key 25383799
Device
Product problems
- Poor Quality Image
- Optical Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER RETURNED THE RIGID VIDEO LAPAROSCOPE WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING EVALUATION OF THE DEVICE, FAILED LIGHT SOURCE AND IMAGE OVERLAPPED HORIZONTALLY AND DID NOT SHIFT VERTICALLY AT A DISTANCE OF 30MM. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.