VERSIUS SURGICAL SYSTEM
Received Jul 9, 2026 · Event occurred May 13, 2025
Report 3015488559-2026-00127 · MDR key 25758430
Device
Product problems
- Insufficient Device Problem Information
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CMR SURGICAL LIMITED IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REGULATIONS. IF ANY FURTHER INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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
RETROSPECTIVE DATA WAS ADDED TO THE REGISTRY WHICH ALLEGED THAT A HEMICOLECTOMY PROCEDURE ON (B)(6) 2025 REQUIRED TO BE CONVERTED TO LAPAROSCOPIC SURGERY. AT THE TIME OF THIS SUBMISSION FOLLOW UP WITH THE SURGICAL TEAM TO GATHER FURTHER INFORMATION HAS SO FAR BEEN UNSUCCESSFUL. 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.