BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    70 DEGREE CURVED SUCTION, EM

    MDR report key: 2912116 · Received January 11, 2013

    Report

    Report Number
    1723170-2013-00016
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 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

    PATIENT INFORMATION NOT AVAILABLE FROM SITE AT TIME OF THIS REPORT. RMA ISSUED. REPLACEMENT DEVICE SHIPPED TO SITE (B)(4) 2012. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE FINDS THE LASER WELD WAS NOT COMPLETED BETWEEN THE SUCTION BLOCK AND SUCTION TUBE. THE WELD ONLY GOES AROUND ABOUT ONE HALF OF THE TUBE CIRCUMFERENCE. MANUFACTURING DEFECT DIRECTLY CAUSED EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE EVALUATION PROVIDED IN THE ATTACHED FOLLOW-UP RESPONSE TO THE FDA 45DAY RESPONSE.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REPRESENTATIVE REPORTED THAT WHILE IN AN ENT PROCEDURE, A SUCTION TUBE ON THE 70 DEGREE CURVED SUCTION DISENGAGED FROM THE HANDLE. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE FUSION NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18792 70 DEGREE CURVED SUCTION, EM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 10355

    Patients

    Seq Age Sex Outcome Treatment
    1