MalfunctionHAW
NDI PASSIVE SPHERES
Received May 5, 2015 · Event occurred Mar 23, 2015
Report 3002743211-2015-00020 · MDR key 4749146
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THIS EVENT WAS COMMUNICATED BY MEDTRONIC NAVIGATION WHO REPORTED THAT A SITE ((B)(6) HOSPITAL) HAD SPHERES THAT WOULD NOT TRACK. SITE REPLACED SPHERES ON INSTRUMENT AND CASE PROCEEDED. SITE REPORTED SPHERES LOOKED LIKE SPHERES WERE SCUFFED. SITE DISPOSED OF SPHERES, DID NOT RECORD LOT NUMBER AND DID NOT TAKE ANY PICTURES OF THE SPHERES. COMPLAINANT REPORTED THAT THERE WAS NO ADVERSE EVENT TO THE PATIENT. NO PATIENT/USER INJURY OR OTHER SERIOUS HARM OCCURRED.