VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 14, 2026 · Event occurred Apr 28, 2026
Report 9610773-2026-03757 · MDR key 25167689
Device
Product problems
- Poor Quality Image
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. CUSTOMER NAME- (B)(6). CUSTOMER ADDRESS- (B)(6).
Description of Event or Problem
IT WAS REPORTED THAT RIGID VIDEO LAPAROSCOPE HAD ABNORMAL IMAGE. THE EVENT OCCURRED DURING LAPA KIDNEY THERAPEUTIC PROCEDURE WHILE THE PATIENT WAS UNDER SEDATION. THE INTENDED PROCEDURE WAS COMPLETED USING A SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: A COMPONENT FAILURE OF THE R-UNIT (CHARGED COUPLED DEVICE). A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.