VERSIUS SURGICAL SYSTEM
Received Jul 9, 2026 · Event occurred Jun 16, 2026
Report 3015488559-2026-00129 · MDR key 25762689
Device
Product problems
- Intermittent Communication Failure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS ALLEGED THAT THE SURGEON CONSOLE RAISED A MEDIUM PRIORITY ALARM DURING START UP. THE CUSTOMER TRIED TO RECOVER THE CONSOLE, BUT IT WAS NOT POSSIBLE. THE PROCEDURE WAS POSTPONED TO THE FOLLOWING DAY AND SUCCESSFULLY CARRIED OUT WITH VERSIUS SURGICAL SYSTEM. TELEMETRY ANALYSIS FOUND A LOSS OF COMMUNICATION WITH ONE OF THE CONSOLE COMPONENTS. INSPECTION OF THE DEVICE CONFIRMED THE ISSUE AND THE RELEVANT ASSEMBLY WAS REPLACED. CABLING IN THE RIGHT HANDCONTROLLER ARM WAS ALSO RESEATED. NO HARM WAS REPORTED IN RELATION TO THIS EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.
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.