LIGHT SOURCE "CLV-S30", 300 W, XENON, 230 V
Received Jun 15, 2026 · Event occurred Jun 19, 2025
Report 3002808148-2026-20323 · MDR key 25501494
Device
Product problems
- Activation Problem
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: BULB DOES NOT WORK. 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 XENON LIGHT SOURCE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS THE BULB DOES NOT WORK WAS FOUND. IT WAS DETERMINED THAT THE BULB NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.