VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jul 10, 2026 · Event occurred Apr 15, 2026
Report 9610773-2026-04878 · MDR key 25788661
Device
Product problems
- Break
- Poor Quality Image
- Output Problem
Patient
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, THE MOST PROBABLE CAUSE OF THE FAILED THE VISUAL TEST FOR THE DISTAL END COVER GLASS, THE FUNCTIONAL TEST FOR THE LIGHT GUIDE (LG) BUNDLE, AND THE FUNCTIONAL TEST FOR THE IMAGING DEVICE COMPONENT WAS TRACED TO COMPONENT FAILURE. 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 DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN IDENTIFIED THAT THE DEVICE HAD FAILED THE VISUAL TEST FOR THE DISTAL END COVER GLASS, THE FUNCTIONAL TEST FOR THE LIGHT GUIDE (LG) BUNDLE, AND THE FUNCTIONAL TEST FOR THE IMAGING DEVICE COMPONENT AND DETERMINED THAT THE ISSUE WAS MOST LIKELY DUE TO COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.