BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBE, ENV FRAZIER SUCTION

    MDR report key: 2043195 · Received February 24, 2011

    Report

    Report Number
    1723170-2011-00155
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. DEVICE MANUFACTURE DATE NOT AVAILABLE AT TIME OF THIS REPORT. THE DEVICE HAD NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION AT THE TIME OF THIS REPORT. RMA ISSUED.

    Description of Event or Problem · 1

    A MEDTRONIC MEDICRAFT REPRESENTATIVE, REPORTED THAT THE FRAZIER SUCTION NEEDS TO BE REPLACED. THE TIP WILL ONLY VERIFY IN A SPECIFIC ORIENTATION AND GIVES A 2.4 DISTANCE TO DIVOT ERROR WHEN ROTATED IN A DIFFERENT DIRECTION. NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROBE, ENV FRAZIER SUCTION STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE