BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRODEBRIDER 1898200T IGS M4

    MDR report key: 3132253 · Received May 29, 2013

    Report

    Report Number
    1045254-2013-00400
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ERL
    PMA / PMN Number
    K041413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). EVALUATION SUMMARY: DEVICE ANALYSIS DETERMINED THAT THE MOTOR HAD INTERMITTENT PROBLEMS; IT FAILED THE HI-POT TEST, PLUS IT RUNS CONTINUOUSLY. BEARINGS AND SEALS WERE CORRODED. MOTOR/CABLE, BEARING SEALS AND OTHER PARTS WERE REPLACED. THE ITEM WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE RUNS AND STOPS ON IT'S OWN, THERE WAS NO PATIENT IMPACT. CONFIRMED WITH THE USER THAT THE DEVICE WOULD START WHEN THE FOOT PEDAL WAS PRESSED, STOP WHEN IT WAS LET UP, BUT THEN IT WOULD START AGAIN ON IT'S OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236018 MICRODEBRIDER 1898200T IGS M4 DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED, INC. 1898200T 51481100

    Patients

    Seq Age Sex Outcome Treatment
    1