MalfunctionHAW
NDI PASSIVE SPHERES
Received Dec 3, 2014 · Event occurred Nov 11, 2014
Report 3002743211-2014-00048 · MDR key 4346763
Device
Generic name
Reflective Passive Marker Spheres, Haw, Olo
Manufacturer
Northern Digital, Inc.Model number
8801075Product 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. 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 OR OTHER SERIOUS HARM OCCURRED.