VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jun 26, 2026 · Event occurred Mar 25, 2026
Report 9610773-2026-04617 · MDR key 25636820
Device
Product problems
- Poor Quality Image
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION INSTEAD PRODUCT WAS RETURNED TO DISTRIBUTOR YUANYU FOR INSPECTION, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE IS LIKELY ATTRIBUTED TO A 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. HOWEVER, DURING THE EVALUATION, THE DEVICE FAILED THE APPEARANCE TEST DUE TO DAMAGE ON THE UNIVERSAL CORD AND FIBER BUNDLE, FAILING THE CRITERION OF NO SEVERE SCRATCHES, CUTS, OR EXCESSIVE KINKS. IN ADDITION, THE DEVICE FAILED THE 3D IMAGE FUNCTIONAL TEST, AS THE IMAGES DID NOT MEET THE REQUIREMENTS FOR DISTORTION-FREE AND BLUR-FREE VISUALIZATION, ACCURATE COLOR RENDERING, AND CONSISTENT BRIGHTNESS AND COLOR BETWEEN THE LEFT AND RIGHT EYES. THERE WAS NO PATIENT INVOLVEMENT.