VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 12, 2026 · Event occurred Apr 22, 2026
Report 9610773-2026-03692 · MDR key 25148624
Device
Product problems
- Image Orientation Incorrect
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, 3 DIMENSION IMAGE WHERE THE PICTURE IS FLIPT DUE TO CAUSE COULD NOT BE DETERMINE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE DISPLAYED A 3 DIMENSION IMAGE IN WHICH THE PICTURE WAS FLIPPED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.