BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARYNGOSCOPE

    MDR report key: 2903574 · Received December 31, 2012

    Report

    Report Number
    2903574
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    October 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    KARL STORZ
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    LARYNGOSCOPE HANDLE BROKE AT THE HEAD DURING INTUBATION. THE HANDLE CAME IN CONTACT WITH PATIENT'S GUM, CAUSING BLEEDING FROM A MINOR INJURY.THIS DEVICE, IN OUR OPINION, IS OF A POOR DESIGN. THE PRESS FITTING OF THE HANDLE WITH THE HEAD OF THE DEVICE IS NOT SUBSTANTIAL ENOUGH TO DEAL WITH THE LEVERAGE AND TORQUE THAT IS PRESENTED DURING USE. THIS FAILURE COULD HAVE CAUSED MAJOR DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARYNGOSCOPE LARYNGOSCOPE, HANDLE CCW KARL STORZ 8546 WZ4

    Patients

    Seq Age Sex Outcome Treatment
    1 *