MalfunctionHAW
NDI PASSIVE SPHERES
Received Mar 5, 2015 · Event occurred Feb 3, 2015
Report 3002743211-2015-00008 · MDR key 4573776
Device
Product problems
- Positioning Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
NOT RETURNED TO MANUFACTURER.
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, 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.