VERSIUS SURGICAL SYSTEM
Received Jul 8, 2026 · Event occurred Jun 10, 2026
Report 3015488559-2026-00108 · MDR key 25745205
Device
Product problems
- Connection Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CMR SURGICAL LIMITED IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REGULATIONS. 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
THE REPORTER ALLEGED THAT DURING SURGICAL SET UP THERE WAS AN ISSUE WITH THE P-STOP. THE BUTTON WAS ACTIVATING WITHOUT IT BEING PRESSED. INSPECTION OF THE DEVICE CARRIED OUT BY A FIELD SERVICE ENGINEER, REVEALED A STICKY RESIDUE COVERING THE BOARD, INCLUDING THE BUTTONS. NO HARM HAS OCCURED TO PATIENT OR USER. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. 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.