MalfunctionHAW
NDI PASSIVE SPHERES
Received Mar 5, 2015 · Event occurred Jan 28, 2015
Report 3002743211-2015-00010 · MDR key 4573759
Device
Generic name
Reflective Passive Marker Spheres
Manufacturer
Northern Digital Inc.Model number
8801075Lot number
1407291
Product problems
- Positioning Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
STERILE SPHERE WOULD NOT TRACK DURING PROCEDURE. SPHERES WERE REPLACED WITH ANOTHER SET OF STERILE SPHERES AND PROCEDURE WAS COMPLETED. THIS EVENT WAS COMMUNICATED BY MEDTRONIC NAVIGATION. SITE/USER DISPOSED OF DEVICE AND DID NOT TAKE ANY PICTURES OF THE DEVICE. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PATIENT/USER INJURY OR OTHER SERIOUS HARM OCCURRED.
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MANUFACTURER.