VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0°
Received Apr 14, 2026 · Event occurred Mar 11, 2026
Report 9610773-2026-02994 · MDR key 24872679
Device
Product problems
- Degraded
- Poor Quality Image
- Failure to Clean Adequately
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE CHARGED COUPLED DEVICE WAS BROKEN AND THEREFORE A NOISE IMAGE OCCURS. CAUSE NOT ESTABLISHED FOR OTHER EVENTS. 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 OBSERVED DURING DEVICE EVALUATION, THAT THE RIGID VIDEO LAPAROSCOPE EXHIBITED CHARGED COUPLED DEVICE BROKEN, NOISE IMAGE AND THE PLUG OF THE VIDEO CABLE SECTION CONTAIN FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.