BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRICUT® ANGLE-TIP BRONCHIAL BLADE

    MDR report key: 3980130 · Received August 5, 2014

    Report

    Report Number
    1045254-2014-00170
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 12, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: 1898200T: MICRODEBRIDER, 1898200T IGS M4, 510K: K041413, ERL. (B)(4). PRODUCT EVALUATION: NO ANALYSIS RESULTS AVAILABLE. DEVICES WILL NOT BE RETURNED FOR EVALUATION. METHOD: NO TESTING METHODS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC THAT A PHYSICIAN WAS NOTIFIED BY A COLLEAGUE, THAT SOMETIME WITHIN THE PAST 10 YEARS THE FOLLOWING ACCOUNT OCCURRED WHEN A MICRODEBRIDER WAS BEING USED WITH THE TRICUT BLADE: ¿A CASE INVOLVING USE OF THE MICRODEBRIDER FOR AN OBSTRUCTING SQUAMOUS CELL CARCINOMA RESULTED IN AN ANTERIOR SUBGLOTTIC TEAR CAUSING THE PATIENT TO UNDERGO URGENT TRACHEOSTOMY. THE PATIENT WAS DECANNULATED SHORTLY THEREAFTER AND WAS ABLE TO RESUME PLANNED TREATMENT WITH CHEMORADIATION WITHOUT DELAY OF THERAPY.¿ THE DOCTOR HAS CONFIRMED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457796 TRICUT® ANGLE-TIP BRONCHIAL BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. UNKNOWN TRICUT BLADE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention