MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 21, 2026 · Event occurred May 12, 2026
Report 9610773-2026-03914 · MDR key 25240701
Device
Product problems
- Optical Problem
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 LIGHT OUTPUT WAS POOR. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.