MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 24, 2026 · Event occurred Feb 11, 2026
Report 9610773-2026-04024 · MDR key 25266972
Device
Product problems
- Display or Visual Feedback Problem
- Output Problem
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, THE MOST PROBABLE CAUSE OF THE MALFUNCTIONS WAS TRACED TO COMPONENT FAILURE. 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
THE CUSTOMER RETURNED THE RIGID VIDEO LAPAROSCOPE, WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, IMAGE AND LIGHT FUNCTION FAILURE WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT.