NDI PASSIVE SPHERES
Received Jul 24, 2014 · Event occurred Jun 26, 2014
Report 3002743211-2014-00018 · MDR key 4176279
Device
Generic name
Reflective Passive Marker Spheres, Olo
Manufacturer
Northern Digital, Inc.Model number
8801002Lot number
1305181, 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 (B)(4). SPHERES WERE NO RETURNED AS THE DEVICE WAS USED IN A PROCEDURE AND CONSIDERED A BIOHAZARD. DECONTAMINATION OF SPHERE WOULD RENDER INVESTIGATION IMPOSSIBLE. CONTRACT MFR IS STILL EVALUATING DHR BASED ON LOT NUMBER FOR ANY QUAL ISSUES. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PT WAS HARMED AND NO SERIOUS INJURY OCCURRED.