MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 13, 2026 · Event occurred Apr 2, 2026
Report 9610773-2026-03747 · MDR key 25164250
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 THAT THE IMAGE WAS FUZZY AND WILL NOT FOCUS DURING REPROCESSING INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.