VERSIUS SURGICAL SYSTEM
Received Jul 7, 2026 · Event occurred Jun 8, 2026
Report 3015488559-2026-00112 · MDR key 25736508
Device
Product problems
- Insufficient Device Problem Information
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 DEFECTIVEOR THAT IT HAS CAUSED A DEATH OR SERIOUS INJURY. THIS REPORT CONTAINS ALL KNOWN INFORMATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE INVESTIGATION IS COMPLETE.
Description of Event or Problem
REPORTER ALLEGED THAT DURING SURGICAL SET UP ON (B)(6) 2026, THAT THERE WAS AN UNRECOVERABLE ALARM. NO HARM TO PATIENT, NO CLINICALLY SIGNIFICANT DELAY TO THE PROCEDURE. AT THE TIME OF THIS REPORT, NOFURTHER INFORMATION HAS BEEN PROVIDED. CMR SURGICALLTD DOES NOT CONSIDER THIS REPORT AND CONTENT TO BEAN ADMISSION THAT ITS PRODUCT IS DEFECTIVE OR THAT ITHAS CAUSED A DEATH OR SERIOUS INJURY.