VERSIUS SURGICAL SYSTEM
Received Jul 10, 2026 · Event occurred Jun 29, 2026
Report 3015488559-2026-00130 · MDR key 25780764
Device
Product problems
- Failure to Align
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 IS INTENDING TO REQUEST THE INSTRUMENT RETURN AND INSPECT THE INSTRUMENT. 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IT WAS ALLEGED THAT THE BIPOLAR MARYLAND GRASPER BECAME LOCKED IN AN ARTICULATED POSITION AND COULD NOT BE WITHDRAWN THROUGH THE TROCAR. THE INSTRUMENT REMAINED IN THE TROCAR UNTIL THE END OF THE PROCEDURE AND WAS REMOVED TOGETHER WITH THE TROCAR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO HARM WAS REPORTED IN RELATION TO THIS EVENT. ANALYSIS OF THE SURGERY VIDEO SHOWS THAT THE INSTRUMENT WAS USED TO PUSH TISSUE SIDEWAYS, AFTER WHICH IT APPEARS THAT THE DISTAL END WAS DISLOCATED FROM THE SHAFT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.