MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jul 14, 2026 · Event occurred Jun 23, 2026
Report 9610773-2026-04930 · MDR key 25817587
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 NOISY SCREEN DURING REPROCESSING INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WAS NO PATIENT INVOLVEMENT.