MalfunctionGCM
VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0°
Received Jun 10, 2026 · Event occurred Jun 2, 2026
Report 9610773-2026-04360 · MDR key 25456987
Device
Product problems
- Poor Quality Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED A WHITE BALANCE ISSUE DURING INSPECTION FOR USE INVOLVING AN OLYMPUS RIGID VIDEO SCOPE. THE UNKNOWN PROCEDURE WAS COMPLETED WITH THE SAME DEVICE THERE WAS NO PATIENT HARM.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.