MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 24, 2026
Report 9610773-2026-04012 · MDR key 25266403
Device
Product problems
- Image Display Error/Artifact
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 ONE SIDE OF THE 3D IMAGE OF THE RIGID VIDEO LAPAROSCOPE WAS DARK. THERE WERE NO REPORTS OF PATIENT HARM.