BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® UNKNOWN

    MDR report key: 5278804 · Received December 9, 2015

    Report

    Report Number
    1045254-2015-00421
    Event Type
    Malfunction
    Date Received
    December 9, 2015
    Report Date
    September 15, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT DEVICE: EC300: MASTER CONSOLE EC300, LEGEND EHS, S/N (B)(4), LOT 62672100, MANUFACTURED 06/30/2009, 510K K081475, HBE. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT: (B)(6) 2015 IT WAS ORIGINALLY REPORTED AS (B)(6) 2015. DATE RECEIVED BY MANUFACTURER: 12/23/2015.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING STARTUP, THE DEVICE GIVES A SYSTEM ERROR AND THE MOTOR UNIT (DRILL) GETS REALLY WARM." IT WAS STATED THAT THE CUSTOMER BELIEVES THAT THE CONSOLE CAUSED THE HANDPIECE TO HEAT UP; THE HANDPIECE WAS TESTED WITH OTHER CONSOLES AND DID NOT GET WARM. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813483 XPS® UNKNOWN DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC. UNKNOWN XPS

    Patients

    Seq Age Sex Outcome Treatment
    1