NDI PASSIVE SPHERES
Received Jul 2, 2015 · Event occurred Jun 2, 2015
Report 3002743211-2015-00036 · MDR key 4888593
Device
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 A CUSTOMER REPRESENTATIVE WHO REPORTED THAT A SITE ((B)(6)) HAD SPHERES THAT DID NOT TRACK. SITE REPLACED SPHERES AND THE NEW SPHERES WERE ABLE TO TRACK. COMPLAINANT REPORTED THAT THERE WAS NO PATIENT/USER INJURY, DEATH OR OTHER SERIOUS DETERIORATION IN HEALTH.
Additional Manufacturer Narrative
VISUALIZATION OF THE DEVICE INDICATES NON-REFLECTIVE AREAS ON THE SPHERE. THE NON-REFLECTIVE SURFACE IS QUITE SMALL COMPARED TO THE OVERALL REFLECTIVENESS OF THE SPHERE. THE ORIGIN/CAUSE OF THE NON-FLECTIVE PORTIONS IS EITHER A MANUFACTURING DEFECT OR CAME ABOUT DURING HANDLING OF THE SPHERE BY THE USER.