VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Apr 30, 2026 · Event occurred Apr 14, 2026
Report 9610773-2026-03408 · MDR key 25045302
Device
Product problems
- Image Display Error/Artifact
- Optical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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: THE THREE DIMENSIONAL IMAGE HAD DEFECTS OR WAS NOT DISPLAYED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: DUE TO THE BROKEN VIDEO CABLE, THE THREE DIMENSIONAL IMAGE HAD DEFECTS OR WAS NOT DISPLAYED. ADDITIONALLY, REGARDING THE PROBLEMS WITH THE LENS, A DEFINITIVE 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 HAD A PROBLEM WITH THE LENS. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.