NEOCIS GUIDANCE SYSTEM
Received Sep 19, 2025 · Event occurred Apr 23, 2025
Report 3012787974-2025-80097 · MDR key 23094726
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Bradycardia
- Bradycardia
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED. THE ADVERSE EVENT WAS RELATED TO THE PATIENT'S CONDITION AND REACTION TO ANESTHESIA, NOT THE USE OF THE DEVICE. WITH REVIEW OF AVAILABLE INFORMATION, THERE ARE NO INDICATIONS OF A MALFUNCTION OF THE DEVICE OR FAILURE TO MEET SPECIFICATIONS. THE USER SELECTED TO REMOVE THE YOMILINK BONE DURING THE EMERGENCY. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND STABILIZED.
Description of Event or Problem
IT WAS REPORTED THAT PRIOR TO THE ROBOTIC PROCEDURE AND FOLLOWING ADMINISTRATION OF ANESTHESIA, THE PATIENT'S HEART RATE DROPPED. THE USER REMOVED THE YOMILINK BONE QUICKLY AND CALLED EMERGENCY SERVICES. THE PATIENT WAS TAKEN TO THE HOSPITAL AND STABILIZED. NO FURTHER INJURIES OR MEDICAL INTERVENTION WERE REPORTED AS A RESULT OF THIS EVENT.