VERSIUS SURGICAL SYSTEM
Received Jul 9, 2026 · Event occurred Jun 11, 2026
Report 3015488559-2026-00120 · MDR key 25764414
Device
Product problems
- Intermittent Communication Failure
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. THE DEVICE WAS INSPECTED BY THE DISTRIBUTOR. 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, DURING PLANNED MAINTENANCE, THE SURGEON CONSOLE WENT INTO MEDIUM PRIORITY ALARM. THE CONSOLE WAS INSPECTED AND THE LEFT HANDGRIP WAS REPLACED. TELEMETRY ANALYSIS CONFIRMS A COMMUNICATION FAULT IN THE LEFT HAND CONTROLLER. FOLLOWING THE REPLACEMENT, THE CONSOLE WAS FULL FUNCTIONAL AND HAS BEEN USED SINCE WITH NO REPORTED ISSUES. NO HARM WAS REPORTED IN RELATION TO THIS EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.