VISERA 4K UHD XENON LIGHT SOURCE
Received Apr 16, 2026 · Event occurred Mar 24, 2026
Report 3002808148-2026-11867 · MDR key 24901440
Device
Product problems
- Electrical Power Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 EXHIBITED CABLE SPARKS WHEN THEY TRIED TO PLUG IT INTO THE LIGHT CABLE. THE ISSUE OCCURRED DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, WHICH WAS COMPLETED WITH AN OLYMPUS BACKUP DEVICE. NO PATIENT HARM WAS REPORTED.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: H2, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A PROBABLE 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.
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.