VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Apr 28, 2026 · Event occurred Jan 27, 2026
Report 9610773-2026-03340 · MDR key 25018057
Device
Product problems
- Display or Visual Feedback Problem
- No Device Output
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE EXHIBITED FAILURE IN LIGHT SOURCE FUNCTION, FAILURE IN 3 DIMENSIONAL IMAGE FUNCTION AND IMAGE EXHIBIT HORIZONTAL OVERLAP AND NO VERTICAL DISPLACEMENT. 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 FOLLOWING LED TO THE MALFUNCTION: LIGHT SOURCE FUNCTION WAS FAILED DUE TO A COMPONENT FAILURE OF THE LIGHT GUIDE BUNDLE. HOWEVER, 3 DIMENSIONAL IMAGE FUNCTION FAILURE AND IMAGE EXHIBIT HORIZONTAL OVERLAP AND NO VERTICAL DISPLACEMENT WAS CAUSED DUE TO FAILURE OF THE ELECTRONICAL COMPONENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.