BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL

    MDR report key: 5541591 · Received March 30, 2016

    Report

    Report Number
    MW5061414
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Date of Event
    December 21, 2015
    Report Date
    March 18, 2016
    Manufacturer
    MEDTRONIC (1-800-962-9888)
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CRANIOTOMY AND CLIPPING OF ANEURYSM AND WHILE USING MIDAS DRILL, SURGEON NOTED BLACK DEBRIS COMING OUT OF THE ATTACHMENT FROM THE ELECTRIC DRILL. IRRIGATED WITH ANTIBIOTICS. CULTURE NEGATIVE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190816 DRILL DRILL HBE MEDTRONIC (1-800-962-9888)

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR