inforMED
MalfunctionHAW

NDI PASSIVE SPHERES

Received Dec 3, 2014 · Event occurred Oct 24, 2014

Report 3002743211-2014-00046 · MDR key 4346768

Device

Generic name

Reflective Passive Marker Spheres, Haw, Olo

Model number

8801075

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 INTERMITTENTLY TRACKING 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, 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.