VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jul 15, 2026 · Event occurred Jun 22, 2026
Report 9610773-2026-04943 · MDR key 25825976
Device
Product problems
- Break
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 TRACED DUE 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 DEVICE EVALUATION, THE MENISCUS OF THE (R-UNIT) CHARGE-COUPLED DEVICE SECTION WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.