BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBE

    MDR report key: 9367278 · Received November 24, 2019

    Report

    Report Number
    1723170-2019-05741
    Event Type
    Malfunction
    Date Received
    November 24, 2019
    Date of Event
    November 7, 2019
    Report Date
    February 6, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994335968
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBE HAS NOT BEEN RETURNED FOR ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PROBE 9733457 PEDICLE 2.25MM (LOT# 170222) WAS RETURNED FOR ANALYSIS. ANALYSIS FOUND THAT THE RETURNED PROBE HAD A VISIBLY BENT TIP. THE PROBE RETURNED A GOOD GEOMETRY ERROR WITH MARKERS ATTACHED AND FULLY SEATED, BUT A HIGH DIVOT ERROR DUE TO THE BENT TIP. 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 DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT DURING SERVICING THE PRODUCT WAS DAMAGED IN APPEARANCE. THE TIP WAS BENT. THE DECISION WAS MADE TO NOT REPLACE THE PROBE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161551 PROBE INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733457 170222 00613994335968

    Patients

    Seq Age Sex Outcome Treatment
    1