NDI PASSIVE SPHERES
Received Dec 3, 2014 · Event occurred Oct 16, 2014
Report 3002743211-2014-00045 · MDR key 4346765
Device
Generic name
Reflective Passive Marker Spheres, Haw, Olo
Manufacturer
Northern Digital, Inc.Model number
8801075Lot number
1407141
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
STERILE SPHERE WERE NOT DETECTED BY CAMERA DURING PROCEDURE. ANOTHER SET OF STERILE SPHERES WERE USED TO COMPLETE THE PROCEDURE WITHOUT ANY FURTHER ISSUES NOTED. THIS EVENT WAS COMMUNICATED BY MEDTRONIC NAVIGATION. SITE/USER DISPOSED OF DEVICE AND DID NOT TAKE ANY PICTURES OF THE DEVICE. CONTRACT MANUFACTURER EVALUATED DHR BASED ON LOT NUMBER. NO QUALITY ISSUES WERE NOTED DURING IN PROCESS INSPECTIONS. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PATIENT WAS HARMED AND NO SERIOUS INJURY OCCURRED.