VERSIUS SURGICAL SYSTEM
Received Jun 30, 2026 · Event occurred Jun 22, 2026
Report 3015488559-2026-00105 · MDR key 25664617
Device
Product problems
- Break
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 TWO MEDIUM PRIORITY ALARMS OCCURRED DURING A SURGICAL PROCEDURE. BOTH ALARMS COULD BE RECOVERED, HOWEVER, WHEN THE SECOND ALARM OCCURRED, THE SURGEON CHOSE TO CONVERT TO MANUAL LAPAROSCOPIC APPROACH AS THEY HAD ONLY ONE SUTURE LEFT TO DO FROM TELEMETRY, IT CAN BE SEEN THAT BOTH ALARMS WERE DUE TO THE SAME ERROR ON A CONTROL BOARD. THIS ERROR SUGGESTS THAT THERE IS A HARDWARE ISSUE DUE TO A DAMAGED WIRE WITHIN THE BOARD. THE JOINT WHICH CONTAINS THE BOARD WAS REPLACED. NO HARM WAS REPORTED IN RELATION TO THIS EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.