NDI PASSIVE SPHERES
Received Sep 25, 2014 · Event occurred Sep 2, 2014
Report 3002743211-2014-00037 · MDR key 4134633
Device
Generic name
Reflective Passive Marker Spheres; Haw, Olo
Manufacturer
Northern Digital, Inc.Model number
8801074, 8801075Lot number
1406141, -5311, -6191
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. CLINICAL SPECIALIST REPORTED SOME OF THE SPHERES SHOWED VISIBLE DAMAGE. ATTEMPTED TO WIPE OFF SPHERES, BUT ENDED UP CHANGING THEM OUT. ANOTHER SET OF STERILE SPHERES WERE USED TO COMPLETE THE PROCEDURE WITHOUT ANY ISSUE. THIS EVENT WAS COMMUNICATED BY MEDTRONIC NAVIGATION. SITE/USER DID NOT TAKE PICTURES OF SPHERE. STILL WAITING FOR SITE/USER TO RETURN SPHERES. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PATIENT WAS HARMED AND NO SERIOUS INJURY OCCURRED.