MalfunctionHAW
NDI PASSIVE SPHERES
Received Mar 19, 2015 · Event occurred Feb 4, 2015
Report 3002743211-2015-00013 · MDR key 4617237
Device
Generic name
Reflective Passive Marker Spheres
Manufacturer
Northern Digital Inc.Model number
8801075Lot number
1408281
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THIS EVENT WAS COMMUNICATED BY MEDTRONIC NAVIGATION WHO REPORTED THAT A SITE HAD SPHERES THAT WOULD NOT TRACK DURING A PROCEDURE. SITE REPLACED SPHERES COMPLETED THE CASE WITHOUT DELAY OR ADVERSE EVENT. SITE/USER DISPOSED OF SPHERES AND DID NOT TAKE ANY PICTURES. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PATIENT/USER INJURY OR OTHER SERIOUS HARM OCCURRED.
Additional Manufacturer Narrative
NOT RETURNED TO MANUFACTURER.