BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLADE EXTENDER FOR ADULT LARYNGOSCOPE, 6/PKG

    MDR report key: 1579904 · Received January 13, 2010

    Report

    Report Number
    1519132-2010-00002
    Event Type
    Other
    Date Received
    January 13, 2010
    Date of Event
    March 1, 2009
    Report Date
    January 13, 2010
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXTENDER BLADE WAS NOT RETURNED. A REVIEW OF PAST INCIDENTS AND RECENT TESTING DATA LEADS TO A CONCLUSION THAT THE DEVICE WAS NOT FASTENED SECURELY TO THE LARYNGOSCOPE PRIOR TO INTUBATION. REMOVAL OF THE BLADE EXTENDER IS QUITE DIFFICULT UNLESS AN LAR-ER REMOVING TOOL IS USED. THUS, NORMAL USAGE WILL NOT RESULT IN THE DEVICE DETACHING FROM THE LARYNGOSCOPE.

    Description of Event or Problem · 1

    WHILE USING THE BULLARD LARYNGOSCOPE FOR INTUBATION, THE PLASTIC EXTENDER PIECE DETACHED AND WAS LEFT IN THE PATIENT'S THROAT. THE PATIENT RETURNED HOME AND COUGHED UP THE EXTENDER PIECE THE FOLLOWING DAY AFTER THE PROCEDURE. THERE WAS NO PATIENT HARM. THIS INCIDENT WAS REPORTED TO GYRUS ACMI IN DECEMBER, 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADE EXTENDER FOR ADULT LARYNGOSCOPE, 6/PKG BLADE EXTENDER FOR ADULT LARYNGOSCOPE CCW GYRUS ACMI, INC. LAR-AE NONE

    Patients

    Seq Age Sex Outcome Treatment
    1