NDI PASSIVE SPHERES
Received Aug 13, 2014 · Event occurred Jul 7, 2014
Report 3002743211-2014-00021 · MDR key 4088706
Device
Generic name
Reflective Passive Marker Spheres, Haw, Olo
Manufacturer
Northern Digital, Inc.Model number
8801075Product 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 STERILE SPHERES WERE USED TO COMPLETE THE PROCEDURE. THIS ISSUE WAS COMMUNICATED BY MEDTRONIC NAVIGATION. SPHERES WERE NOT RETURNED AS THE DEVICE WAS USED IN A PROCEDURE AND CONSIDERED A BIOHAZARD. DECONTAMINATION OF SPHERE WOULD RENDER INVESTIGATION IMPOSSIBLE. SITE/USER DID NOT TAKE PICTURE OF SPHERE. THEREFORE, NO INVESTIGATION OR ANALYSIS COULD BE PERFORMED. SITE/USER DID NOT RETAIN LOT NUMBER INFORMATION. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PT WAS HARMED AND NO SERIOUS INJURY OCCURRED.