NDI PASSIVE SPHERES
Received Jul 11, 2014 · Event occurred Jun 12, 2014
Report 3002743211-2014-00016 · MDR key 4170574
Device
Generic name
Reflective Passive Marker Spheres
Manufacturer
Northern Digital, Inc.Model number
8801071Lot number
1309071
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 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 PICTURES OF SPHERE. THEREFORE, NO INVESTIGATION OR ANALYSIS COULD BE PERFORMED. CONTRACT MFR IS STILL EVALUATING DHR BASED ON LOT NUMBER FOR ANY QUALITY ISSUES. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PT WAS HARMED AND NO SERIOUS INJURY OCCURRED.