MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 7, 2026 · Event occurred Apr 15, 2026
Report 9610773-2026-03606 · MDR key 25113786
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 AND THE REPORTED FAILURE WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
IT WAS REPORTED THE RIGID VIDEO LAPAROSCOPE EXPERIENCED THE IMAGE IS BLURRY AND FOGGY DURING A LAPAROSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.