BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XOM UNKNOWN ENDO

    MDR report key: 4759844 · Received May 8, 2015

    Report

    Report Number
    1045254-2015-00154
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Report Date
    March 27, 2015
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF THE EVENT IS UNKNOWN. HOWEVER, THE INITIAL REPORTER STATED THAT THE PRODUCT EVENT TOOK PLACE THE WEEK OF (B)(6) 2015. CONCOMITANT MEDICAL DEVICES: 1899200 ¿ M5 MICRODEBRIDER; MANUFACTURED DATE ¿ SEPTEMBER 4, 2014; S/N ¿ (B)(4); LOT ¿ 208718126; 510K - K081277. (B)(4). THE PRODUCT ANALYSIS INDICATES THAT THE HANDPIECE AND BROKEN BUR WERE RETURNED FOR EVALUATION. UPON REMOVING THE HANDPIECE FROM A PLASTIC BAG, A BROKEN BUR FELL OUT. THE HANDPIECE SHOWED NO SIGNIFICANT PHYSICAL DAMAGE. THE HANDPIECE WAS CONNECTED TO THE CONSOLE AND OPERATED AT DEFAULT SPEED. IT SOUNDED AND FUNCTIONED NORMALLY. ONLY A SMALL PORTION OF THE BUR WAS RETURNED. ALTHOUGH THE PART NUMBER COULD NOT BE IDENTIFIED, ITS GRAY HUB INDICATED THAT IT WAS A HIGH SPEED BUR AND THE INNER AND OUTER HUBS WERE MELTED TOGETHER. THE SERVICE REPORT INDICATES THAT THE CUSTOMER COMPLAINT WAS VERIFIED. THE BUR WAS REMOVED FROM THE COLLET. THE HANDPIECE WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRAINING COURSE, THE TRAINEES WERE GIVEN A HIGH SPEED BUR (NOT INTENDED FOR USE AT 30K RPMS) TO USE WITH THE M5 HANDPIECE. THE TRAINEES WERE ASKED NOT TO RUN THE BURS AT 30K RPMS, BUT DID IT ANYWAY. AS A RESULT, THE HIGH SPEED BUR BROKE AND GOT STUCK IN THE HANDPIECE. THE TRAINING COURSE TOOK PLACE IN A MEDTRONIC TRAINING LAB. THERE WAS NO PATIENT INVOLVED AND NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303336 XOM UNKNOWN ENDO EQJ MEDTRONIC XOMED, INC. XOM UNKNOWN ENDO

    Patients

    Seq Age Sex Outcome Treatment
    1