MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 8, 2026
Report 9610773-2026-03625 · MDR key 25122623
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
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE DISPLAYED A VERTICAL LINE ON THE IMAGE. THE ISSUE WAS IDENTIFIED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.