VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 28, 2026 · Event occurred Apr 20, 2026
Report 9610773-2026-04134 · MDR key 25325398
Device
Product problems
- Poor Quality Image
- Scratched Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE MOST PROBABLE CAUSE OF THE MALFUNCTION IS TRACED TO COMPONENT FAILURE OF OBJECTIVE LENS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. 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
THE CUSTOMER RETURNED THE RIGID VIDEO LAPAROSCOPE WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING EVALUATION OF THE DEVICE, SCRATCHED OBJECTIVE LENS AND IMAGE FLARE WAS FOUND. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE FAILURES WERE COMPONENT FAILURE OF OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.