MalfunctionHAW
NDI PASSIVE SPHERES
Received Mar 25, 2015 · Event occurred Dec 4, 2014
Report 3002743211-2015-00014 · MDR key 4631148
Device
Generic name
Reflective Passive Marker Spheres
Manufacturer
Northern Digital Inc.Model number
8801075Lot number
UNKNOWN
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 AND COMPLETED THE CASE WITHOUT ANY ADVERSE EVENTS. SITE/USER DISPOSED OF SPHERES, DID NOT RECORD LOT NUMBER 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.