VERSIUS SURGICAL SYSTEM
Received Jul 1, 2026 · Event occurred Jun 12, 2026
Report 3015488559-2026-00110 · MDR key 25677371
Device
Product problems
- Poor Quality Image
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CMR SURGICAL IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REGULATION 803 . CMR SURGICAL LTD DOES NOT CONSIDER THISREPORTAND CONTENT TO BE AN ADMISSION THAT ITS PRODUCT IS DEFECTIVE OR THAT IT HAS CAUSED ADEATH OR SERIOUS INJURY. ALL INFORMATIONKNOWN ATTHE TIME OF THIS REPORT HAS BEEN INCLUDED.
Description of Event or Problem
REPORTER ALLEGED THAT DURING SURGERY ON 12 JUNE 2026, THE CAMERA HEAD HAD A SMALL BLACK DOT ON THE IMAGE.. THE PROCEDURE CONTINUED WITH A SPARE CAMERA HEAD. NO HARM TO PATIENT, NO SIGNIFICANT DELAY TO THE PROCEDURE. 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.