MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jun 10, 2026 · Event occurred Apr 28, 2026
Report 9610773-2026-04359 · MDR key 25456943
Device
Product problems
- Optical Problem
Patient
Not reported
- 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 BRIGHTNESS IS POOR EVEN WHEN TURNED UP, FOUND DURING REPROCESSING INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.