VERSIUS SURGICAL SYSTEM
Received Jul 14, 2026 · Event occurred Jun 19, 2026
Report 3015488559-2026-00135 · MDR key 25810676
Device
Product problems
- Difficult to Open or Close
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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND INSPECTED. CMR SURGICAL LIMITED 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
THE REPORTER ALLEGED THAT DURING A LEFT INFERIOR LOBECTOMY PROCEDURE ON (B)(6) 2026, WHILST USING A BIPOLAR MARYLAND GRASPER PART OF THE LUNG'S TISSUE GOT STUCK IN THE JOINT AND WAS UNABLE TO REMOVE THE TISSUE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. 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 INJURIES.