VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 8, 2026 · Event occurred Apr 16, 2026
Report 9610773-2026-03630 · MDR key 25124471
Device
Product problems
- Degraded
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: PROBLEMS WERE TRACED TO THE DEVICE, BUT THE INVESTIGATION COULD NOT IDENTIFY THE ACTUAL ROOT CAUSE. 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 FOREIGN MATERIAL AT THE LIGHT GUIDE CABLE PLUG OF THE VIDEO CABLE SECTION. THERE WAS NO PATIENT INVOLVEMENT.