BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INST 960-615 PROBE LINEAR BLUNT TIP

    MDR report key: 8241594 · Received January 11, 2019

    Report

    Report Number
    1723170-2019-00219
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    December 14, 2018
    Report Date
    February 4, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION FOUND THAT THE RETURNED PROBE WAS VERY FADED AND WORN. THE CABLE WAS NOT DAMAGED, BUT THE CABLE STRAIN RELIEF WAS TORN AT THE PROBE END. THERE WERE NO INTERNAL WIRES EXPOSED. 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 AN INSTRUMENT USED WITH A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE BLUNT TIP PROBE HAD A DAMAGED CABLE. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32608 INST 960-615 PROBE LINEAR BLUNT TIP INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 960-615 147216

    Patients

    Seq Age Sex Outcome Treatment
    1