MalfunctionSCV
VERSIUS SURGICAL SYSTEM
Received Jul 6, 2026 · Event occurred Jun 12, 2026
Report 3015488559-2026-00114 · MDR key 25716123
Device
Product problems
- Communication or Transmission Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CMR SURGICAL LIMITED IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REGULATION 803. CMR SURGICAL LTD DOES NOT CONSIDER THIS REPORT AND CONTENT TO BE AN ADMISSION THAT ITS PRODUCT IS DEFECTIVE OR THAT IT HAS CAUSED A DEATH OR SERIOUS INJURY.
Description of Event or Problem
IT WAS ALLEGED THAT THE ICG FUNCTION WAS NOT AVAILABLE DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH VERSIUS SURGICAL SYSTEM, WITHOUT ICG. THE SURGEON CONSOLE WAS INSPECTED AND A FLASH DRIVE WAS REPLACED. NO HARM WAS REPORTED IN RELATION TO THIS EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.