MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 28, 2026 · Event occurred May 13, 2026
Report 9610773-2026-04121 · MDR key 25318878
Device
Product problems
- Poor Quality Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1- INITIAL REPORTER ESTABLISHMENT NAME- (B)(6). 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 THE RIGID VIDEO LAPAROSCOPE EXHIBITED IMAGE AUTOMATICALLY SWITCHED BETWEEN 2D AND 3D. THE ISSUE OCCURRED DURING THE REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.