VERSIUS SURGICAL SYSTEM
Received Jul 8, 2026 · Event occurred Jun 10, 2026
Report 3015488559-2026-00125 · MDR key 25745849
Device
Product problems
- Poor Quality Image
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. THIS REPORT CONTAINS ALL KNOWN INFORMATION.
Description of Event or Problem
REPORTER ALLEGED THAT DURING A CHOLECSTECTOMY PROCEDURE ON (B)(6) 2026, AFTER INDOCYANINE GREEN (ICG) WAS GIVEN THE SCREEN GREENED OUT, WITH A CONSEQUENCE OF NO IDENTIFICATION OF THE BILE DUCTS. THE REPORTER CONFIRMED THE PROCEDURE CONTINUED AS PLANNED WITHOUT VLIMELITE AND NO HARM TO PATIENT WAS INVOLVED. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. CMR SURGICAL LTD DOES NOT CONSIDER THIS REPORT AND CONTENT TO BEAN ADMISSION THAT ITS PRODUCT IS DEFECTIVE OR THAT IT HAS CAUSED A DEATH OR SERIOUS INJURY.