BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRODEBRIDER 1898200T IGS M4

    MDR report key: 3107080 · Received May 10, 2013

    Report

    Report Number
    1045254-2013-00377
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Report Date
    April 16, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ERL
    PMA / PMN Number
    K041413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCT: (1) XPS 3000 CONSOLE (1897102); SN: (B)(4); LOT: 35546000; MANUFACTURED: OCTOBER 5, 2004; RETURNED TO MEDTRONIC: (B)(4) 2013. (B)(4). ONLY THE XPS 3000 CONSOLE, 1897102, WAS RETURNED FOR EVALUATION AND REPAIR. SERVICE AND REPAIR COULD NOT DUPLICATE OR CONFIRM THE ALLEGED COMPLAINT FOR ¿RUN-ON¿. HOWEVER, THE DISPLAY BOARD WAS PHYSICALLY DAMAGED CAUSING THE DEVICE NOT TO WORK PROPERLY. THE DISPLAY BOARD WAS REPLACED ALONG WITH THE PUMP MOTOR DUE TO FAILING THE RPM SPEED TEST. THE DEVICE WAS REPAIRED, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PRE-OPERATIVE SETUP, THE M4 MICRODEBRIDER HANDPIECE BEGAN TO RUN ON ITS OWN AT ABOUT 50-100 RPM WITHOUT THE FOOT PEDAL BEING PRESSED. THE UNIT WAS TURNED OFF AND BACK ON AND OPERATED FINE. NO PATIENT IMPACT OR INJURY WAS REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207811 MICRODEBRIDER 1898200T IGS M4 DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED, INC. 1898200T NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1