MalfunctionHAW
NDI PASSIVE SPHERES
Received Jan 5, 2015 · Event occurred Nov 19, 2014
Report 3002743211-2015-00001 · MDR key 4382102
Device
Generic name
Reflective Marker Spheres
Manufacturer
Northern Digital Inc.Model number
8801075Lot number
1409011
Product problems
- Communication or Transmission Problem
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 INCIDENT. THIS EVENT WAS COMMUNICATED BY MEDTRONIC NAVIGATION. SITE/USER DISPOSED OF DEVICE 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 WAS REPORTED.
Additional Manufacturer Narrative
(B)(4)