NDI PASSIVE SPHERES
Received Sep 29, 2015 · Event occurred Aug 26, 2015
Report 3002743211-2015-00054 · MDR key 5110264
Device
Product problems
- Positioning Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
SPHERES WERE REPORTED TO HAVE AN UNEVEN REFLECTIVE SURFACE. THE SPHERES WHEN ROTATED WOULD RETURN LESS ERROR, HOWEVER, NOT ENOUGH FOR TRACKING TO OCCUR. IT IS NOT CLEAR IF THE UNEVEN REFLECTIVENESS OCCURED AS A RESULT OF THE SURGERY. DEVICE DISCARDED BY SITE.
Description of Event or Problem
THIS EVENT WAS COMMUNICATED BY A MEDTRONIC (B)(4) REPRESENTATIVE FROM (B)(6)HOSPITAL. COMPLAINT WAS THAT THE SPHERES WERE NOT TRACKING. THEY REPLACED THE SPHERES AND WERE ABLE TO CONTINUE THE PROCEDURE. COMPLAINANT REPORTED THAT THERE WAS NO PATIENT/USER INJURY, DEATH OR OTHER SERIOUS DETERIORATION IN HEALTH. NO LOT NUMBER WAS RECORDED BY CUSTOMER. NO PICTURES WERE TAKEN BY THE CUSTOMER.