MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 23, 2026 · Event occurred May 15, 2026
Report 9610773-2026-03992 · MDR key 25264488
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 WHITE AREA APPEARED IN THE CENTER AND A RAINBOW EFFECT. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. 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.