VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0°
Received Jul 17, 2026
Report 9610773-2026-05031 · MDR key 25856904
Device
Product problems
- No Display/Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DATE OF EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED IF AVAILABLE. 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 2 DIMENSIONAL RIGHT CHANNEL HAS NO IMAGE CAUSED BY DEFECTED OUTER TUBE. 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 COLONOVIDEOSCOPE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. HOWEVER, DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN IDENTIFIED THAT THE 2D RIGHT CHANNEL HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.