MalfunctionHAW
NDI PASSIVE SPHERES
Received Jun 8, 2015 · Event occurred Apr 6, 2015
Report 3002743211-2015-00027 · MDR key 4825252
Device
Generic name
Reflective Passive Marker Spheres
Manufacturer
Northern Digital Inc.Model number
8801075Lot number
MULTIPLE
Product problems
- Mechanics Altered
Patient
Not reported
- No Known Impact Or Consequence 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 (LOT NUMBERS 1411261, 1411111, 1410181, 1411191) THAT WOULD NOT TRACK. SITE REPORTED SPHERES APPEARED SCRATCHED BUT DID NOT TAKE ANY PICTURES OF THE SPHERE. COMPLAINANT REPORTED THAT THERE WAS NO PATIENT/USER INJURY, DEATH OR OTHER SERIOUS DETERIORATION IN HEALTH.