BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AWL, 9733161, VMAX, CANNULATED

    MDR report key: 8724766 · Received June 21, 2019

    Report

    Report Number
    1723170-2019-03740
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    January 26, 2018
    Report Date
    June 21, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994258847
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED FOR ANALYSIS AND IT WAS CONFIRMED THAT THE INSTRUMENT WAS BENT. 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 INSTRUMENT USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A BENT AWL TIP FOUND DURING INSPECTION. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518331 AWL, 9733161, VMAX, CANNULATED INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733161 140527 00613994258847

    Patients

    Seq Age Sex Outcome Treatment
    1