VERSIUS SURGICAL SYSTEM
Received Jul 7, 2026 · Event occurred Jun 10, 2026
Report 3015488559-2026-00119 · MDR key 25734254
Device
Product problems
- No Display/Image
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 IS IN TRANSIT. 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 CUSTOMER EXPERIENCED VISION DISRUPTION DURING THE BEGINNING OF A SURGICAL PROCEDURE. THE SURGICAL TEAM REPLACED THE CAMERA HEAD AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH VERSIUS SURGICAL SYSTEM, WITH NO SIGNIFICANT DELAY. THE FAULTY CAMERA HEAD WAS SENT TO CMR SURGICAL. NO HARM WAS REPORTED IN RELATION TO THIS EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.