BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR - UNKNOWN

    MDR report key: 6390081 · Received March 8, 2017

    Report

    Report Number
    1045254-2017-00075
    Event Type
    Malfunction
    Date Received
    March 8, 2017
    Report Date
    February 7, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 3055601 ¿ SKEETER OTO-TOOL DRILL, SERIAL NUMBER ¿ (B)(4), LOT NUMBER - 205913645, MANUFACTURED DATE ¿ MAY 22, 2012, (B)(4), 510K NUMBER - K833874. UNKNOWN BUR: THE PRODUCT ANALYSIS INDICATES THAT THE REPORTED ISSUE WAS CONFIRMED. THE REMAINING PIECE OF BUR WAS STUCK IN THE HANDPIECE/BUR PIPE. THE PHOTO OF THE BROKEN BUR WAS PROVIDED. THE TIP OF THE BUR IS MISSING. 3055601 (SKEETER OTO-TOOL DRILL): THE PRODUCT ANALYSIS INDICATES THAT THE REMAINING PIECE OF BUR WAS STUCK IN THE HANDPIECE/BUR PIPE. THE CABLE WAS CORRODED AND CONNECTOR WAS WORN. THE BUR PIPE WAS DAMAGED. THE REMAINING PIECE OF BUR WAS REMOVED. THE CABLE, CONNECTOR, BUR PIPE, MOTOR, AND ADDITIONAL PARTS WERE REPLACED. THE DEVICE WAS CLEANED AND SUCCESSFULLY TESTED TO SPECIFICATIONS. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUR BROKE AND A PORTION OF THE BUR REMAINED STUCK IN THE BUR PIPE/CHANNEL OF THE HANDPIECE. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169258 XPS® BUR - UNKNOWN BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. XOM UNKNOWN BUR

    Patients

    Seq Age Sex Outcome Treatment
    1