IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K
Received Nov 11, 2021 · Event occurred Oct 29, 2021
Report 1221934-2021-03307 · MDR key 12797716
Device
Product problems
- Display or Visual Feedback Problem
- Display or Visual Feedback Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.
Description of Event or Problem
IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE ARTHROSCOPY SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K DEVICE HAD A GREEN BAR ON THE SCREEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.