VERSIUS SURGICAL SYSTEM
Received Jul 7, 2026 · Event occurred Jun 29, 2026
Report 3015488559-2026-00117 · MDR key 25732138
Device
Product problems
- Material Frayed
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 DISTIBUTOR. 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 SURGEON CONSOLE WENT INTO A MEDIUM PRIORITY ALARM DURING SURGERY AND THE RIGHT HAND CONTROLLER COULD NOT BE MOVED. THE CUSTOMER TRIED TO POWERCYCLE, BUT THE SYSTEM WOULD ALARM WHEN THE RIGHT HAND CONTROLLER WAS MOVED. THE PROCEDURE WAS COMPLETED WITH VERSIUS SURGICAL SYSTEM, USING ANOTHER SURGEON CONSOLE. THE DISTRIBUTOR INVESTIGATED AND FOUND BROKEN CABLE ON THE RIGHT LINKAGE. THE LINKAGE WAS REPLACED. NO HARM WAS REPORTED IN RELATION TO THIS EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.