VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0°
Received May 1, 2026
Report 9610773-2026-03447 · MDR key 25056142
Device
Product problems
- Optical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD AN IMAGE DEFECT. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: CHARGED COUPLED DEVICE WAS BROKEN, THE OUTER TUBE HAD A DENT, AND THE PROTECTOR OF THE VIDEO CABLE SECTION WAS CUT. 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 CHARGED COUPLED DEVICE WAS BROKEN, THE PIXEL SHIFT WAS INCORRECT. ADDITIONALLY, FOR THE OUTER TUBE HAD A DENT, AND THE PROTECTOR OF THE VIDEO CABLE SECTION WAS CUT, 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.