MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jul 2, 2026 · Event occurred Jun 12, 2026
Report 9610773-2026-04725 · MDR key 25693486
Device
Product problems
- Poor Quality Image
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
THE CUSTOMER REPORTED IMAGE NOISE, REQUEST TO INSPECT 3D IMAGE DURING INSPECTION FOR USE INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WAS NO PATIENT INJURY REPORTED.