BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR - STYLUS TRANSNASAL

    MDR report key: 6411324 · Received March 16, 2017

    Report

    Report Number
    1045254-2017-00085
    Event Type
    Malfunction
    Date Received
    March 16, 2017
    Date of Event
    February 8, 2017
    Report Date
    October 17, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    PMA / PMN Number
    K081277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: EM200 (MOTOR, LEGEND EHS STYLUS); SERIAL NUMBER - (B)(4); LOT NUMBER ¿ 206167425; MANUFACTURED DATE ¿ SEPTEMBER 14, 2012; UDI NUMBER ¿ (B)(4); 510K NUMBER - K012457. THE DEVICE WAS DISCARDED BY THE CUSTOMER. A PRODUCT ANALYSIS HAS NOT BEEN PERFORMED. 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 DURING PREOPERATIVE PREPARATION, THE BUR OVERHEATED SEVERAL SECONDS AFTER BEING USED. A NEW BUR, SAME PRODUCT NUMBER FROM A DIFFERENT LOT, WAS USED TO COMPLETE THE PROCEDURE AND THERE WERE NO FURTHER ISSUES. THERE WAS NO PATIENT OR USER IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193064 XPS® BUR - STYLUS TRANSNASAL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC. TN45RCD 0211274889

    Patients

    Seq Age Sex Outcome Treatment
    1