MalfunctionHAW
NDI PASSIVE SPHERES
Received Apr 2, 2015 · Event occurred Feb 27, 2015
Report 3002743211-2015-00015 · MDR key 4652022
Device
Product problems
- Positioning Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THIS EVENT WAS COMMUNICATED BY MEDTRONIC NAVIGATION WHO REPORTED THAT A SITE (B)(6) HAD ISSUES TRACKING AN INSTRUMENT DURING A PROCEDURE. SITE REPLACED SPHERES ON INSTRUMENT AND THE INSTRUMENT TRACKED AS IT SHOULD. SITE DISPOSED OF SPHERES, DID NOT RECORD LOT NUMBER AND DID NOT TAKE ANY PICTURES. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PATIENT/USER INJURY OR OTHER SERIOUS HARM OCCURRED.