BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX PERFORATOR DRIVER

    MDR report key: 7457528 · Received April 25, 2018

    Report

    Report Number
    7457528
    Event Type
    Malfunction
    Date Received
    April 25, 2018
    Date of Event
    August 2, 2017
    Report Date
    April 23, 2018
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    GFF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS UTILIZING THE MIDAS REX DRILL TO ENTER SKULL FOR CRANIOTOMY. WHEN THE PERFORATOR STOPPED, THE REGULATOR (MIDAS REX DRILL) CONTINUED TO SPIN, WRAPPING THE CORD AROUND THE DEVICE 4-5 TIMES. SURGEONS' HAND WAS CAUGHT IN THE CORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305789 MIDAS REX PERFORATOR DRIVER MOTOR, DRILL, PNEUMATIC GFF MEDTRONIC POWERED SURGICAL SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR CODMAN DISPOSABLE PERFORATOR (DRILL BIT FOR THE MI