MalfunctionHAW
NDI PASSIVE SPHERES
Received Oct 16, 2014 · Event occurred Sep 15, 2014
Report 3002743211-2014-00039 · MDR key 4184428
Device
Generic name
Reflective Passive Marker Spheres, Haw,olo
Manufacturer
Northern Digital, Inc.Model number
8801085Lot number
1405311
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
REFLECTIVE STERILE SPHERES FAILED TO TRACK DURING A PROCEDURE. ANOTHER SET OF SPHERES WERE USED TO COMPLETE THE PROCEDURE WITHOUT AN ISSUE. THIS EVENT WAS COMMUNICATED BY MEDTRONIC NAVIGATION. SITE/USER DISPOSED OF DEVICE AND DID NOT TAKE ANY PICTURES OF THE DEVICE. DHR WAS REVIEWED AND NO QUALITY ISSUES WERE NOTED. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PATIENT WAS HARMED AND NO SERIOUS INJURY OCCURRED.