VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 7, 2026 · Event occurred Apr 14, 2026
Report 9610773-2026-03598 · MDR key 25108863
Device
Product problems
- Image Display Error/Artifact
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO REGIONAL REPAIR CENTER FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: THE CHARGED COUPLED DEVICE WAS BROKEN AND THEREFORE THE IMAGE WAS NOT DISPLAYED. 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.
Description of Event or Problem
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE DISPLAYED A STRIPE IN THE IMAGE. THE ISSUE WAS IDENTIFIED DURING AN INSPECTION PRIOR TO USE. THERE WERE NO REPORTS OF PATIENT HARM.