BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRODEBRIDER 1898200T IGS M4

    MDR report key: 3221731 · Received July 11, 2013

    Report

    Report Number
    1045254-2013-00453
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    June 12, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ERL
    PMA / PMN Number
    K041413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. IN AS RECEIVED CONDITION, THE DEVICE WAS NOT WORKING DUE TO THE MOTOR BEING SEIZED. AS A RESULT THE CUSTOMER¿S COMPLAINT CONCERNING THE DEVICE OVERHEATING COULD NOT BE VERIFIED OR CONFIRMED. BEARINGS AND OTHER PARTS REQUIRED REPLACEMENT DUE TO CORROSION. THE DEVICE WAS REPAIRED, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDTRONIC M4 MICRODEBRIDER HANDPIECE OVERHEATED DURING TESTING. THERE WAS NO REPORT OF PATIENT IMPACT OR INVOLVEMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320118 MICRODEBRIDER 1898200T IGS M4 DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED, INC. 1898200T 73796900

    Patients

    Seq Age Sex Outcome Treatment
    1