VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0°
Received Jun 6, 2026 · Event occurred May 15, 2026
Report 9610773-2026-04308 · MDR key 25419237
Device
Product problems
- Poor Quality Image
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: COMPONENT FAILURE OF THE CHARGED COUPLED DEVICE. 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
THE CUSTOMER RETURNED THE RIGID VIDEO LAPAROSCOPE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE IMAGE MISALIGNMENT WAS OBSERVED. THE SERVICE REPAIR TECHNICIAN ASSESSED THE CONDITION AND DETERMINED THAT THE DAMAGE WAS DUE TO A COMPONENT FAILURE OF THE CHARGED COUPLED DEVICE. THERE WAS NO PATIENT INVOLVEMENT.