MalfunctionHAW
NDI PASSIVE SPHERES
Received May 5, 2015 · Event occurred Mar 20, 2015
Report 3002743211-2015-00021 · MDR key 4749119
Device
Product problems
- Communication or Transmission 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) HOSPITAL) HAD SPHERES THAT WOULD NOT TRACK. SITE REPLACED SPHERES ON INSTRUMENT AND CASE PROCEEDED. SITE DISPOSED OF SPHERES, DID NOT RECORD LOT NUMBER AND DID NOT TAKE ANY PICTURES OF THE SPHERES. COMPLAINANT REPORTED THAT THERE WAS NO ADVERSE EVENT TO THE PATIENT. NO PATIENT/USER INJURY OR OTHER SERIOUS HARM OCCURRED.