BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR - UNKNOWN

    MDR report key: 4946194 · Received July 28, 2015

    Report

    Report Number
    1045254-2015-00258
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Date of Event
    June 22, 2015
    Report Date
    June 23, 2015
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCT: MICRODEBRIDER 1898200TRF IGS M4 REFURB, 510K: K041413, ERL, SERIAL #(B)(4), LOT# 39319900, MFR DATE: 2005-07-08. (B)(4). THE PRODUCT ANALYSIS FOR THE HANDPIECE FOUND THAT THE BUR WAS STUCK IN THE COLLET, THERE WERE NO OTHER ISSUES WITH THE HANDPIECE. ONCE THE BUR WAS REMOVED FROM THE COLLET, THE HANDPIECE PASSED ALL MANUFACTURING SPECIFICATIONS. THE PRODUCT ANALYSIS FOR THE HIGH SPEED BLADE FOUND THAT ONLY THE INNER HUB AND A PORTION OF THE INNER SHAFT OF THE HIGH SPEED BUR WERE RETURNED. THE BLUE COLOR OF THE HUB INDICATES THAT IT WAS A HIGH SPEED BUR, BUT LOT NUMBER IS STILL NOT KNOWN. THE INNER HUB WAS DEFORMED AT THE DISTAL FACE WHICH MAY HAVE CONTRIBUTED TO THE REPORTED MALFUNCTION. WHEN VIEWED UNDER MAGNIFICATION, THE SHAFT WAS CONSISTENT WITH BEING CUT OFF AND/OR POTENTIALLY BENT. THE SPIRAL WRAP WAS BROKEN AND WRAPPED IN ON ITSELF. IT COULD NOT BE DETERMINED WHEN THE DAMAGE TO THE DEVICE TOOK PLACE THEREFORE THE INTEGRITY OF THE RETURNED SAMPLE IS NOT INTACT TO CONFIRM OR REFUTE THE ALLEGED FAILURE.

    Description of Event or Problem · 1

    THE BUR WAS REPORTED TO HAVE BROKEN DURING A CASE. THE BUR WAS STUCK AND BENT INSIDE. THERE WERE NO FRAGMENTS OR IMPACT TO THE PATIENT. DR. (B)(6) DOES NOT REMEMBER IF THE BUR GOT HOT OR NOT. ACCORDING TO THE DOCTOR, THE BUR WAS NOT CUT IN AN ATTEMPT TO REMOVE IT FROM THE HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491906 XPS® BUR - UNKNOWN BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC XOM UNKNOWN BUR

    Patients

    Seq Age Sex Outcome Treatment
    1