BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH

    MDR report key: 1053274 · Received May 9, 2008

    Report

    Report Number
    1053274
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 9, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    THE FLEX SCOPE WAS INTRODUCED INTO THE NOSE AND NASOPHARYNX. THE FLEX SCOPE WAS REMOVED, AND THE PT WAS REPOSITIONED. THE TOOTHGUARD WAS PLACED. WITH THE HELP OF AN LARYNGOSCOPE (#3.5) WITH A RIGID BRONCHOSCOPE, THE LARYNGOSCOPE WAS PLACED INTO THE MOUTH AND LARYNX. THE LARYNGOSCOPE WAS REMOVED AND THE BRONCHOSCOPE WAS ADVANCED. THE BRONCHOSCOPE WAS REMOVED. PT INTUBATED AND IT WAS NOTED THAT THE LARYNGOSCOPE BLADE LIGHT BULB HAD BROKEN AT TIP, AND HAD FALLEN INTO THE POST PHARYNGEAL WALL WITH SECRETIONS. THE PT WAS SUCTIONED AND A PIECE OF THE LIGHT BULB WAS STILL ATTACHED TO LARYNGOSCOPE. THE PIECE HAD FALLEN OFF WHILE MD WAS HANDLING THE DEVICE. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH BLADE, LARYNGOSCOPE CCW TELEFLEX MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR