BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR - UNKNOWN

    MDR report key: 6391345 · Received March 9, 2017

    Report

    Report Number
    1045254-2017-00076
    Event Type
    Malfunction
    Date Received
    March 9, 2017
    Date of Event
    December 16, 2016
    Report Date
    February 12, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: 3055601 ¿ SKEETER OTO-TOOL DRILL; SERIAL NUMBER - (B)(4); LOT NUMBER ¿ 34595700; MANUFACTURED DATE ¿ JULY 14, 2004; UDI NUMBER ¿ (B)(4); 510K NUMBER - K833874. THE PRODUCT ANALYSIS INDICATES THAT THE REPORTED ISSUE WAS CONFIRMED. THE BROKEN BUR WAS FOUND STUCK INSIDE THE HANDPIECE AND THE MOTOR WAS FAULTY. THE BROKEN BUR WAS REMOVED AND THE MOTOR WAS REPLACED. THE HANDPIECE WAS SUCCESSFULLY TESTED TO SPECIFICATION. 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 INTRAOPERATIVE, THE BUR BROKE AND WAS STUCK INSIDE THE HANDPIECE. THE BUR BREAK RESULTED IN A FRAGMENT(S) THAT REQUIRED RETRIEVAL FROM INSIDE THE PATIENT. THE FRAGMENT(S) WAS SUCCESSFULLY RETRIEVED WITH NO ADDITIONAL SURGICAL PROCEDURE OR EQUIPMENT NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172748 XPS® BUR - UNKNOWN BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. XOM UNKNOWN BUR

    Patients

    Seq Age Sex Outcome Treatment
    1