MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Apr 16, 2026
Report 9610773-2026-03070 · MDR key 24899096
Device
Product problems
- Poor Quality Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD FOGGY LENS DURING OPERATIONS. THE ISSUE WAS FOUND DURING A SET UP. THERE WERE NO REPORTS OF 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.