MalfunctionHAW
NDI PASSIVE SPHERES
Received May 19, 2015 · Event occurred Mar 27, 2015
Report 3002743211-2015-00025 · MDR key 4782636
Device
Product problems
- Device Operates Differently Than Expected
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) HOSPITAL) HAD SPHERES THAT WOULD NOT TRACK. SPHERES WERE SWITCHED OUT WITH A NEW PACKAGE OF SPHERES. SITE DISPOSED OF SPHERES, DID NOT RECORD LOT NUMBER AND DID NOT TAKE ANY PICTURES OF THE SPHERES. COMPLAINANT REPORTED THAT THERE WAS NO DELAY OR ADVERSE EVENT TO THE PATIENT. NO PATIENT/USER INJURY OR OTHER SERIOUS HARM OCCURRED.