NDI PASSIVE SPHERES
Received Jul 11, 2014 · Event occurred Dec 5, 2013
Report 3002743211-2014-00005 · MDR key 4170669
Device
Generic name
Reflective Passive Marker Sphere - Haw, Olo
Manufacturer
Northern Digital, Inc.Model number
8801002Lot number
1303061
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 SALES AND SUPPORT MGR WHICH OCCURRED AT (B)(6). SPHERES WERE RETURNED HOWEVER, NO INVESTIGATION OR ANALYSIS COULD BE DONE AS SPHERES WERE USED IN A PROCEDURE AND POTENTIALLY CONTAMINATED. DECONTAMINATION OF SPHERE WOULD RENDER INVESTIGATION IMPOSSIBLE. THEREFORE, NO INVESTIGATION OR ANALYSIS COULD BE PERFORMED. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PT WAS HARMED AND NO SERIOUS INJURY OCCURRED.