MalfunctionHAW
NDI PASSIVE SPHERES
Received Mar 16, 2015 · Event occurred Feb 6, 2015
Report 3002743211-2015-00011 · MDR key 4606086
Device
Product problems
- Positioning Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THIS EVENT WAS COMMUNICATED BY MEDTRONIC NAVIGATION WHO REPORTED THAT A SITE HAD A STERILE SPHERE THAT WOULD NOT TRACK DURING A PROCEDURE. SITE REPORTED NO DELAY TO CASE OR ANY ADVERSE EVENTS. 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.