BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION

    MDR report key: 8704100 · Received June 17, 2019

    Report

    Report Number
    1723170-2019-03438
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    May 23, 2019
    Report Date
    July 23, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994378477
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CURVED SUCTION WAS RETURNED TO THE MANUFACTURE FOR EVALUATION. AFTER FUNCTIONAL TESTING AND VISUAL/PHYSICAL EXAMINATION THE REPORTED ISSUE WAS CONFIRMED. THE RETURNED CURVED SUCTION WAS VISIBLY BENT. WHEN ATTACHED TO A KNOWN GOOD TRACKER THE SUCTION WAS NOT IDENTIFIED AND WOULD NOT VERIFY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE 70 DEGREE SUCTION WAS BENT BY THE HEALTH CARE PROFESSIONAL INSIDE OF THE PATIENT ANATOMY. THERE WAS NO DELAY TO THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497403 FUSION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733450 16071321 00613994378477

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR