VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Apr 14, 2026
Report 9610773-2026-02999 · MDR key 24872866
Device
Product problems
- Erratic or Intermittent Display
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THE RIGID VIDEO LAPAROSCOPE EXPERIENCED THAT THE IMAGE IS FLICKERING. THERE WERE NO REPORTS OF PATIENT HARM.
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8, H3, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: THE COVERGLASS OF THE INSERTION SECTION HAS VISIBLE FOREIGN MATERIAL. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.