MalfunctionHAW
NDI PASSIVE SPHERES
Received Oct 30, 2014 · Event occurred Sep 23, 2014
Report 3002743211-2014-00043 · MDR key 4260993
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 FAILED TO TRACK DURING A PROCEDURE. ANOTHER SET OF STERILE SPHERES WERE USED TO COMPLETE THE PROCEDURE WITHOUT ANY ISSUE. THE ISSUE HAD NO DELAY TO SURGERY. THIS EVEN TWAS COMMUNICATED BY MEDTRONIC NAVIGATION. SITE/USER DISPOSED OF DEVICE AND DID NOT TAKE ANY PICTURES OR RECORD LOT NUMBER OF THE DEVICE. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PATIENT WAS HARMED AND NO SERIOUS INJURY OCCURRED.