BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XOM UNKNOWN ENDO

    MDR report key: 3590771 · Received January 24, 2014

    Report

    Report Number
    1045254-2014-00018
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Report Date
    January 2, 2014
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS : * 1845020, INDIGO ANGLED ATTACHMENT, SERIAL # (B)(4), LOT # 20611096; K081475, HBE, MANUFACTURE DATE 09/2012. * 1845000 INDIGO HIGH SPEED OTOLOGIC DRILL, SEIRAL # (B)(4), LOT # 206315563; K081475; MANUFACTURE DATE 11/2012. THE ATTACHMENT RETURNED WAS VISUALLY REVIEWED AND CONFIRMED THERE WAS A PORTION OF A BUR STUCK IN THE DEVICE. RESULTS - FRACTURE PROBLEM.

    Description of Event or Problem · 1

    LJF06/06/14 IT WAS REPORTED THE HANDPIECE AND ATTACHMENT WERE RUNNING ROUGH. DURING ANALYSIS A BROKEN BUR WAS FOUND STUCK IN ATTACHMENT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56623 XOM UNKNOWN ENDO EQJ MEDTRONIC XOMED, INC. XOM UNKNOWN ENDO

    Patients

    Seq Age Sex Outcome Treatment
    1