MalfunctionHAW
NDI PASSIVE SPHERES
Received Jul 11, 2014 · Event occurred May 9, 2014
Report 3002743211-2014-00009 · MDR key 4170629
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
REFLECTIVE STERILE SPHERES FAILED TO TRACK DURING A PROCEDURE. ANOTHER SET OF STERILE SPHERES WERE USED TO COMPLETE THE PROCEDURE. THIS ISSUE WAS COMMUNICATED BY MEDTRONIC NAVIGATION. SPHERES WERE USED IN A PROCEDURE AND THEREFORE NOT RETURNED. DECONTAMINATION OF SPHERE WOULD RENDER INVESTIGATION IMPOSSIBLE. SITE/USER DID NOT TAKE PICTURES OF SPHERE. LOT NUMBERS WERE NOT PROVIDED. THEREFORE NO INVESTIGATION OR ANALYSIS COULD BE PERFORMED. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PT WAS HARMED AND NO SERIOUS INJURY OCCURRED.