MalfunctionHAW
NDI PASSIVE SPHERES
Received May 5, 2015 · Event occurred Apr 7, 2015
Report 3002743211-2015-00023 · MDR key 4749152
Device
Generic name
Reflective Passive Marker Spheres
Manufacturer
Northern Digital Inc.Model number
8801075Lot number
1309061
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 (B)(4) WHO REPORTED THAT A SITE (HOSPITAL: (B)(6)) HAD SPHERES THAT WOULD NOT TRACK. PROCEDURE WAS COMPLETED WITH BACK-UPS. SITE DISPOSED OF SPHERES AND DID NOT TAKE ANY PICTURES OF THE SPHERES. COMPLAINANT REPORTED THAT THERE WAS NO DELAY OR ADVERSE EVENT TO THE PATIENT. NO PATIENT/USER INJURY OR OTHER SERIOUS HARM OCCURRED.