BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INST KIT PROBE THORACIC ASSY

    MDR report key: 8861380 · Received August 5, 2019

    Report

    Report Number
    1723170-2019-04371
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    July 10, 2019
    Report Date
    October 16, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    UDI-DI
    00763000207625
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION:THE PROBE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THAT THE TIP OF THE RETURNED PROBE WAS TWISTED. THERE WERE ALSO IMPACT MARKS AT THE BACK END CAUSING FIT ISSUES WITH THE MATING TRACKER. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE TIP OF THE THORACIC PROBE WAS BENT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE INSTRUMENT COULD NOT BE VERIFIED AND USED BECAUSE OF THE BENT TIP. IT WAS REPORTED THAT THE CAUSE WAS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655324 INST KIT PROBE THORACIC ASSY ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 9734680 180629 00763000207625

    Patients

    Seq Age Sex Outcome Treatment
    1