BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    70 DEG CURVED SUCTION, AXIEM¿

    MDR report key: 2964024 · Received February 15, 2013

    Report

    Report Number
    1723170-2012-00698
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PROVIDED CORRECT LOT NUMBER AND DEVICE MANUFACTURER DATE.MANUFACTURER NARRATIVE:THE MEDTRONIC REPRESENTATIVE WAS INFORMED THAT INSTRUMENTS SHOULD BE REPLACED IF THEY WILL NOT CONSISTENTLY VERIFY, AND THAT THEY SHOULD NOT BE MANIPULATED IN ORDER TO PASS VERIFICATION.

    Additional Manufacturer Narrative · 1

    NO PT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION. D4: DEVICE LOT NUMBER IS UNKNOWN PENDING THE DEVICE RETURN. DEVICE MANUFACTURE DATE IS UNKNOWN PENDING THE DEVICE RETURN. SUSPECT PART HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    LOT NUMBER PROVIDED.

    Additional Manufacturer Narrative · 1

    THE INTIAL REPORT IDENTIFIED A STRAIGHT PROBE, EM ENT, THE CORRECT DEVICE IS 70 DEG CURVED SUCTION, AXIEM. THE INTIAL REPORT IDENTIFIED CATALOG NUMBER 9733447XOM, THE CORRECT CATALOG NUMBER IS 9733450.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED RE-ALIGNING THE STRAIGHT PROBE, EM ENT IN ORDER TO OBTAIN PROPER VERIFICATION. ISSUE WAS RESOLVED, INSTRUMENTS WORKED FINE. THERE WAS NO PT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67163 70 DEG CURVED SUCTION, AXIEM¿ NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 59561700

    Patients

    Seq Age Sex Outcome Treatment
    1