VERSIUS SURGICAL SYSTEM
Received Jul 9, 2026 · Event occurred Jun 16, 2026
Report 3015488559-2026-00128 · MDR key 25760301
Device
Product problems
- Premature Discharge of Battery
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. 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 ON (B)(6) 2026 THE INSTRUMENT BEDSIDE UNIT (IBSU) WENT INTO AN UNRECOVERABLE MEDIUM PRIORITY ALARM (MPA), DUE TO THE ARM NOT BEING IN THE CORRECT FOLDED POSTION. A SPARE IBSU WAS USED FOR THE PROCEDURE. NO PATIENT IMPACT. 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.