MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 31, 2026 · Event occurred May 28, 2026
Report 9610773-2026-04162 · MDR key 25341159
Device
Product problems
- No Display/Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED NO IMAGE ON ONE SIDE DURING INSPECTION FOR USE INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Additional Manufacturer Narrative
E1: (B)(6). E1: (B)(6). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.