MalfunctionHAW
NDI PASSIVE SPHERES
Received Apr 2, 2015 · Event occurred Mar 4, 2015
Report 3002743211-2015-00017 · MDR key 4652025
Device
Product problems
- Device Inoperable
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 ((B)(6) HOSPITAL) HAD BAD SPHERES. SITE REPLACED SPHERES AND NEW INSTRUMENT WERE ABLE TO TRACK. SITE 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.