MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 12, 2026
Report 9610773-2026-03711 · MDR key 25154563
Device
Product problems
- 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
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD WHITE BALANCE ISSUE. THE ISSUE HAD OCCURRED DURING INSPECTION FOR USE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.