BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOR EM210 LEGEND STYLUS TOUCH

    MDR report key: 3232924 · Received July 18, 2013

    Report

    Report Number
    1045254-2013-00462
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCT: LEGEND STYLUS TOUCH #EM210, SN# (B)(4), LOT#206345498; MFR DATE: 11/17/2012. (B)(4). THE TWO DEVICES WERE RETURNED FOR EVALUATION AND REPAIR BY THE QUALITY ENGINEERING TEAM. ANALYSIS FOR EM210 (B)(4), THE PRODUCT FAILURE ANALYSIS FOUND THERE WAS NO SIGNIFICANT PHYSICAL DAMAGE; HOWEVER, THE DRILL COULD NOT BE TAKEN OUT OF THE ¿SAFE¿ MODE. THUS, THE REPORTED COMPLAINT FOR ¿GETTING HOT¿ COULD NOT BE CONFIRMED, AS TEMPERATURE TESTING COULD NOT BE PERFORMED. ANALYSIS FOR EM210 (B)(4) THE PRODUCT FAILURE ANALYSIS FOUND THE CONDITION OF THE DEVICE SHOWED THE SAFETY SWITCH ON THE FINGER LEVER HAD DETACHED. THE DRILL COULD NOT BE TAKEN OUT OF THE ¿SAFE¿ MODE; THUS, THE REPORTED COMPLAINT FOR ¿GETTING HOT¿ COULD NOT BE CONFIRMED, AS TEMPERATURE TESTING COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE HANDPIECE GO HOT ALMOST IMMEDIATELY AFTER LOADING THE BUR AND POWERING ON THE DEVICE. THE HANDPIECE WAS SET ASIDE AND A SECOND HANDPIECE OF THE SAME MODEL WAS THEN OBTAINED. THE BUR WAS LOADED INTO THE HANDPIECE AND POWERED ON AND IT ALSO GOT HOT ALMOST IMMEDIATELY. THE SECOND HANDPIECE WAS SET ASIDE AND A THIRD HANDPIECE OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333958 MOTOR EM210 LEGEND STYLUS TOUCH BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC. EM210 73617800

    Patients

    Seq Age Sex Outcome Treatment
    1