MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 24, 2026 · Event occurred May 19, 2026
Report 9610773-2026-04019 · MDR key 25266870
Device
Product problems
- Poor Quality Image
Patient
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 THE RIGID VIDEO LAPAROSCOPE IMAGE WAS BLURRED. THIS ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.