VERSIUS SURGICAL SYSTEM
Received Jul 8, 2026 · Event occurred Jun 24, 2026
Report 3015488559-2026-00121 · MDR key 25745605
Device
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS ALLEGED THAT, WHEN REMOVING THE CAMERA CABLE CONNECTOR FROM THE VISUALISATION BEDSIDE UNIT CONNECTOR PANEL, THE CABLE CONNECTOR PIN BROKE IN THE SOCKET. THE EVENT OCCURRED DURING SURGERY TEAR DOWN. THE VISUALISATION BEDSIDE UNIT PANEL WAS REPLACED. THE CAMERA CABLE WAS REPLACED. NO HARM WAS REPORTED IN RELATION TO THIS EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
CMR SURGICAL LIMITED IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REGULATION 803. THE DEVICE WAS INSPECTED BY THE DISTRIBUTOR. MECHANICAL DAMAGE WAS FOUND, WHICH WAS PROBABLY DUE TO IMPROPER HANDLING DURING CONNECTION AND REMOVAL OF THE CABLE. 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.