MalfunctionHAW
NDI PASSIVE SPHERES
Received Jul 11, 2014 · Event occurred Apr 29, 2013
Report 3002743211-2014-00004 · MDR key 4170677
Device
Generic name
Reflective Passive Marker Sphere - Haw, Olo
Manufacturer
Northern Digital, Inc.Model number
8800967Product problems
- Device Misassembled During Manufacturing /Shipping
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
COMPLAINANT WAS CONCERNED ABOUT ACCURACY OF TRACKING DUE TO A "LOOSE AND WOBBLY" SPHERE ON A TOOL POST. INHOUSE TESTING WAS COMPLETED AND DID NOT SHOW ANY CONCRETED PROOF OR FAILURE MODE ATTRIBUTABLE TO NDI PASSIVE SPHERES. NO "WOBBLY SPHERES" WERE FOUND ON ANY SAMPLES AND DURING TESTING. THIS FAILURE HAS NOT RECURRED SINCE THIS REPORT. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PT WAS HARMED AND NO SERIOUS INJURY OCCURRED.