MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jun 6, 2026 · Event occurred May 13, 2026
Report 9610773-2026-04309 · MDR key 25419369
Device
Product problems
- Image Orientation Incorrect
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 AN AUTOMATICALLY INVERTED IMAGE DURING MAINTENANCE INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.