NDI PASSIVE SPHERES
Received Jul 11, 2014 · Event occurred May 5, 2014
Report 3002743211-2014-00006 · MDR key 4170664
Device
Generic name
Reflective Passive Marker Sphere - Haw, Olo
Manufacturer
Northern Digital, Inc.Model number
8801002Lot number
1303011
Product problems
- Device Operates Differently Than Expected
- Torn Material
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. MARKINGS WERE VISIBLE ON THE SPHERES. ANOTHER SET OF STERILE SPHERE WERE USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THIS ISSUE WAS COMMUNICATED BY SALES AND SUPPORT MGR WHICH OCCURRED AT MORNINGSIDE HOSPITAL IN (B)(6). SPHERES WERE USED IN A PROCEDURE AND THEREFORE NOT RETURNED. INVESTIGATION WAS CARRIED OUT BASED ON PICTURES OF DEFECTIVE DEVICE. MARKS ON THE SPHERE APPEAR TO BE TEARS WITH SHARP EDGES IN THE REFLECTIVE FILM THAT COVERS THE SPHERE. ROOT CAUSE OF REPORTED DEFECT CANNOT BE CLEARLY DETERMINED AS THIS IS A SINGLE OCCURRENCE OF THIS ISSUE. THIS ISSUE HAS NOT REOCCURRED SINCE THIS REPORT. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PT WAS HARMED AND NO SERIOUS INJURY OCCURRED.