BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRODEBRIDER 1898200T IGS M4

    MDR report key: 3020662 · Received March 26, 2013

    Report

    Report Number
    1045254-2013-00298
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 3, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ERL
    PMA / PMN Number
    K041413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4): THE CUSTOMER REPORTED THAT THE HANDPIECE FROZE UP AND WAS GETTING HOT. THE DEVICE WAS RETURNED FOR ANALYSIS. THE OVERHEATING COULD NOT BE CONFIRMED BECAUSE THE HANDPIECE WAS FROZEN. SEVERAL COMPONENTS, INCLUDING THE MOTOR, HOUSING, AND BEARINGS, WERE REPLACED DUE TO CORROSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, A MICRODEBRIDER HAND PIECE WAS NOT WORKING PROPERLY. IT FROZE UP AND WAS GETTING HOT. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123997 MICRODEBRIDER 1898200T IGS M4 DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED, INC. 1898200T 36930200

    Patients

    Seq Age Sex Outcome Treatment
    1