NDI PASSIVE SPHERES
Received Oct 16, 2014 · Event occurred Sep 11, 2014
Report 3002743211-2014-00038 · MDR key 4184458
Device
Generic name
Reflective Passive Marker Spheres, Haw, Olo
Manufacturer
Northern Digital, Inc.Model number
8801085Product 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. ATTEMPTED TO WIPE OFF SPHERES WITH NO CHANGE IN PERFORMANCE. ANOTHER SET OF STERILE SPHERES WERE USED TO COMPLETE THE PROCEDURE WITHOUT ANY ISSUE. THIS EVENT WAS COMMUNICATED BY MEDTRONIC NAVIGATION. SPHERES WERE NOT RETURNED AS THE DEVICE WAS USED IN A PROCEDURE AND CONSIDERED A BIOHAZARD. SITE/USER DID NOT TAKE PICTURES OF SPHERE. SITE/USER DID NOT RETAIN LOT NUMBER INFORMATION. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PATIENT WAS HARMED AND NO SERIOUS INJURY OCCURRED.