BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRODEBRIDER 1898200T IGS M4

    MDR report key: 2862352 · Received December 10, 2012

    Report

    Report Number
    1045254-2012-00702
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 9, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ERL
    PMA / PMN Number
    K041413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR SERVICE AND REPAIR. THE OVERHEATING DEVICE WAS CONFIRMED TO HEAT-UP DURING EVALUATION. THE UNIT'S TEMPERATURES MEASURED BETWEEN 109 AND 132 DEGREES. THE MOST LIKELY ROOT CAUSE IS DETERMINED AS CORRODED BEARINGS. BEARINGS WERE REPLACED AND THE UNIT RECEIVED ADDITIONAL PREVENTATIVE MAINTENANCE; WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER'S SERVICE AND REPAIR DEPARTMENT THAT THE HANDPIECE WAS GETTING HOT. THERE WAS NO PATIENT IMPACT AS THE EVENT OCCURRED DURING TESTING THE DEVICE PREOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRODEBRIDER 1898200T IGS M4 DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL XOMED MFG JACKSONVILLE 1898200T 53851200

    Patients

    Seq Age Sex Outcome Treatment
    1