MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jun 11, 2026 · Event occurred May 11, 2026
Report 9610773-2026-04396 · MDR key 25477408
Device
Product problems
- Image Display Error/Artifact
- Material Deformation
- Optical Problem
Patient
Not reported
- 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
THE DISTRIBUTOR REPORTED THAT THE DEVICE FAILED THE 3D IMAGE TEST. THE DISTAL END HAD OBVIOUS DAMAGE, THE INSERTION SECTION WAS DAMAGED, AND THE LIGHT GUIDE BUNDLE WAS DAMAGED, DURING INSPECTION FOR USE INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WAS NO PATIENT INJURY REPORTED.