BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX

    MDR report key: 12127478 · Received July 7, 2021

    Report

    Report Number
    12127478
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 4, 2021
    Report Date
    June 22, 2021
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE MIDAS REX¿ LEGEND EHS STYLUS HIGH-SPEED SURGICAL DRILL WITH MEDTRONIC MIDAS REX AVS15 15CM VARIABLE EXPOSURE STRAIGHT SMALL BORE ATTACHMENT WERE RETURNED TO CENTRAL STERILE PROCESSING DEPARTMENT WITH REPAIR TAG "COMPLAINT WAS OVERHEATING." REPLACEMENT MIDAS REX DRILL WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029090 MIDAS REX MOTOR, DRILL, ELECTRIC HBC MEDTRONIC POWERED SURGICAL SOLUTIONS EM200

    Patients

    Seq Age Sex Outcome Treatment
    1 19710 DA