BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC REX DRILL

    MDR report key: 588535 · Received March 4, 2005

    Report

    Report Number
    588535
    Event Type
    Malfunction
    Date Received
    March 4, 2005
    Date of Event
    February 23, 2005
    Report Date
    March 4, 2005
    Manufacturer
    MEDTRONIC MIDAS REX
    Product Code
    GET
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A SURGEON WAS USING A MIDAS REX DRILL. THE SURGICAL TECHNICIAN WAS TURNING UP THE NITROGEN, AND THE SURGEON NOTICED SMOKE COMING FROM THE MIDAS REX DRILL. THE OIL RESERVOIR WAS BROKEN ON THE MIDAS REX DRILL. ANOTHER MIDAS REX DRILL WAS SUBSTITUTED AND THE SURGICAL PROCEDURE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC REX DRILL DRILL GET MEDTRONIC MIDAS REX * *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR