MalfunctionHAW
NDI PASSIVE SPHERES
Received Jan 5, 2015 · Event occurred Dec 17, 2014
Report 3002743211-2015-00002 · MDR key 4382126
Device
Product problems
- Accessory Incompatible
- Failure to Sense
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
STERILE SPHERE WERE NOT RECOGNIZED BY SOFTWARE DURING PROCEDURE. SPHERES WERE REPLACED WITH ANOTHER SET OF STERILE SPHERES. NEW SPHERES WERE TRACKED AND PROCEDURE WAS COMPLETED. THIS EVENT WAS COMMUNICATED BY MEDTRONIC NAVIGATION. SITE/USER DISPOSED OF DEVICE, DID NOT RECORD LOT NUMBER AND DID NOT TAKE ANY PICTURES OF THE DEVICE. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PATIENT/USER INJURY OR OTHER SERIOUS HARM OCCURRED.
Additional Manufacturer Narrative
(B)(4)