MalfunctionGCT
VISERA 4K UHD XENON LIGHT SOURCE
Received Jun 17, 2026
Report 3002808148-2026-20678 · MDR key 25534045
Device
Product problems
- Intermittent Loss of Power
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED INTERMITTENT OPERATION ON FUNCTIONAL TESTING DURING INSPECTION FOR USE INVOLVING AN OLYMPUS XENON LIGHT SOURCE. THERE WAS NO PATIENT INJURY REPORTED.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.