MalfunctionHAW
NDI PASSIVE SPHERES
Received Jun 19, 2015 · Event occurred May 21, 2015
Report 3002743211-2015-00034 · MDR key 4856896
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 SPHERES THAT HAD POOR RECOGNITION FROM THE CAMERA. SITE REPLACED SPHERES AND CONTINUED WITH PROCEDURE WITHOUT DELAY. SITE DISPOSED OF PRODUCT, DID NOT TAKE ANY PICTURES OR RECORD LOT NUMBER. COMPLAINANT REPORTED THAT THERE WAS NO PATIENT/USER INJURY, DEATH OR OTHER SERIOUS DETERIORATION IN HEALTH.