VERSIUS SURGICAL SYSTEM
Received Jun 30, 2026 · Event occurred Jun 4, 2026
Report 3015488559-2026-00103 · MDR key 25664118
Device
Product problems
- Vibration
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 ALLAGED THAT THE INSTRUMENT BEDSIDE UNIT WENT INTO MEDIUM PRIORITY ALARM DURING A SURGICAL PROCEDURE. THE UNIT COULD NOT BE RECOVERED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH VERSIUS SURGICAL SYSTEM. THE BEDSIDE UNIT WAS INSPECTED BY FIELD SERVICE ENGINNER. TELEMETRY ANALYSIS REVEALED A POSITION SENSOR FAILURE ON ONE OF THE JOINTS, AS THE CAUSE OF THE ALARM. THE FAULTY JOINT WAS REPLACED. NO HARM WAS REPORTED IN RELATION TO THIS EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.