BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDI PASSIVE SPHERES

    MDR report key: 4170612 · Received July 11, 2014

    Report

    Report Number
    3002743211-2014-00010
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    May 9, 2014
    Report Date
    July 11, 2014
    Manufacturer
    NORTHERN DIGITAL, INC.
    Product Code
    HAW
    PMA / PMN Number
    K033621
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408405 NDI PASSIVE SPHERES REFLECTIVE PASSIVE MARKER SPHERES HAW NORTHERN DIGITAL, INC. 8801075 1308271

    Patients

    Seq Age Sex Outcome Treatment
    1