MalfunctionHAW
NDI PASSIVE SPHERES
Received Mar 19, 2015 · Event occurred Feb 9, 2015
Report 3002743211-2015-00012 · MDR key 4617259
Device
Product problems
- Mechanical Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
THIS EVENT WAS COMMUNICATED BY MEDTRONIC NAVIGATION WHO REPORTED THAT A SITE HAD A TOOL THAT WOULD NOT TRACK DURING A PROCEDURE. SITE REPLACED SPHERES AND TOOL WORKED NORMALLY. 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.