MalfunctionHAW
NDI PASSIVE SPHERES
Received Dec 3, 2014 · Event occurred Nov 19, 2014
Report 3002743211-2014-00047 · MDR key 4346731
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 WERE INTERMITTENTLY TRACKING DURING PROCEDURE. ANOTHER SET OF STERILE SPHERES WERE USED TO COMPLETE THE PROCEDURE WITHOUT ANY FURTHER ISSUES NOTED. 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 INJURY OR OTHER SERIOUS HARM OCCURRED.