MalfunctionHAW
NDI PASSIVE SPHERES
Received Feb 6, 2015 · Event occurred Jan 5, 2015
Report 3002743211-2015-00003 · MDR key 4491699
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
STERILE SPHERE ON A PROBE WERE NOT TRACKING. SPHERES WERE REPLACED WITH ANOTHER SET OF STERILE SPHERES AND THE PROBE FUNCTIONED FORMALLY. SITE REPORTED THAT WAS NO DELAY TO THE CASE AND NO IMPACT TO THE PATIENT. THIS EVENT WAS COMMUNICATED BY MEDTRONIC NAVIGATION. SITE/USER DISPOSED OF DEVICE, DID NOT RECORD LOT NUMBER 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
NOT RETURNED TO MANUFACTURER.