VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 6, 2026
Report 9610773-2026-03585 · MDR key 25097093
Device
Product problems
- Poor Quality Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD NOISY IMAGE. THE ISSUE HAD OCCURRED DURING INSPECTION FOR USE. THERE WAS NO REPORT OF PATIENT HARM.
Additional Manufacturer Narrative
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: POOR RESOLUTION (LEFT) AND COMPONENT FAILURE OF THE CHARGED COUPLER UNIT. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE REPORTED MALFUNCTION COULD NOT BE DETERMINED. HOWEVER, BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE POOR RESOLUTION (LEFT) WAS TRACED TO COMPONENT FAILURE OF THE CHARGED COUPLER UNIT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.