NDI PASSIVE SPHERES

Description of Event or Problem

REFLECTIVE STERILE SPHERES FAILED TO TRACK DURING A PROCEDURE. ANOTHER SET OF STERILE SPHERES WERE USED TO COMPLETE THE PROCEDURE. THIS ISSUE WAS COMMUNICATED BY MEDTRONIC NAVIGATION. SPHERES WERE ANALYZED BY MEDTRONIC NAVIGATION AND REPORTED AS HAVING A "BLOTCHY, IRREGULAR SURFACE". FURTHER ANALYSIS AT NORTHERN DIGITAL INC. WAS NOT COMPLETED AS SPHERES WERE USED IN A PROCEDURE AND CONSIDERED A BIOHAZARD. DECONTAMINATION OF SPHERE WOULD RENDER INVESTIGATION IMPOSSIBLE. SITE/USER DID NOT TAKE PICTURES OF SPHERE. REVIEW OF DHRS SHOWED NO QUALITY ISSUES. CONTRACT MFR (IIMAK) UPDATED PROCEDURES TO INSPECT FOR "BLOTCHY, IRREGULAR SPHERES". HOWEVER, SINCE THIS IS THE ONLY KNOWN OCCURRENCE OF THIS FAILURE, NO ROOT CAUSE CAN BE ESTABLISHED. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PT WAS HARMED AND NO SERIOUS INJURY OCCURRED.