VISERA PRO XENON LIGHT SOURCE
Received Apr 20, 2026 · Event occurred Apr 2, 2026
Report 3002808148-2026-12209 · MDR key 24927872
Device
Product problems
- Activation Failure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE CORRECTION AND RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8, H2, H3, H4, H6, H11. CORRECTED FIELDS: E3. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, A PROBABLE ROOT CAUSE FOR REPORTED FAILURE COULD NOT BE DETERMINED. 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
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE XENON LIGHT SOURCE WAS UNABLE TO LIGHT UP DURING REPROCESSING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.