inforMED
MalfunctionHAW

NDI PASSIVE SPHERES

Received Apr 2, 2015 · Event occurred Apr 9, 2013

Report 3002743211-2015-00018 · MDR key 4652026

Device

Generic name

Reflective Passive Marker Spheres

Model number

8801075

Lot number

1304291 / 1304261

Product problems

  • Device Operates Differently Than Expected
  • Output Problem

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

THIS EVENT WAS COMMUNICATED BY MEDTRONIC NAVIGATION WHO REPORTED THAT A SITE ((B)(6) HOSPITAL) HAD INSTRUMENTS THAT WOULD NOT TRACK. SITE REPLACED SPHERES ON INSTRUMENT AND THEN THE INSTRUMENT WAS ABLE TO TRACK. SITE REPORTED SPHERES LOOKED LIKE THEY WERE SCUFFED. SITE DISPOSED OF SPHERES AND DID NOT TAKE ANY PICTURES OF THE SPHERES. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PATIENT/USER INJURY OR OTHER SERIOUS HARM OCCURRED.