MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 25, 2026 · Event occurred May 18, 2026
Report 9610773-2026-04050 · MDR key 25269190
Device
Product problems
- Erratic or Intermittent Display
- Poor Quality Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE CUSTOMER REPORTED FLICKERING AND VERY DARK IMAGE DURING REPROCESSING INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WAS NO PATIENT INJURY REPORTED.