BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEELITE

    MDR report key: 4004906 · Received July 31, 2014

    Report

    Report Number
    4004906
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 31, 2014
    Manufacturer
    VITAL SIGNS, INC.
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DISPOSABLE GE STEELITE LARYNGOCOPE BLADES HAVE BEEN RECENTLY INTRODUCED IN OUR ANESTHESIA/OPERATING ROOM DEPARTMENT. WHEN USED WITH STORZ HANDLES, THESE DISPOSABLE BLADES PROVIDE SUBOPTIMAL INTUBATING CONDITIONS INCLUDING A FLICKERING LIGHT AND/OR TOTAL DISAPPEARANCE OF LIGHT DURING DIRECT LARYNGOSCOPY, AS NOTICED BY SEVERAL TRAINED CLINICIANS IN OUR DEPARTMENT. DURING AN URGENT ORAL INTUBATION OF A PATIENT, THE PATIENT REQUIRED A RAPID SEQUENCE INDUCTION. A GE STEELITE MAC 3 BLADE WAS TESTED BEFORE INDUCTION AND WAS FOUND FUNCTIONAL. HOWEVER, DURING A DIRECT LARYNGOSCOPY FOLLOWING INDUCTION OF ANESTHESIA, THE LIGHT WENT OFF. TO PREVENT DESATURATION, WE HAD TO MASK VENTILATE THE PATIENT POTENTIALLY INCREASING THE RISK OF ASPIRATION OF GASTRIC CONTENT. THE GE BLADE WAS REPLACED BY A MAC 4 STORZ BLADE AND THE PATIENT WAS UNEVENTFULLY INTUBATED. IN ADDITION, THE DISPOSABLE MAC 3 GE BLADE DAMAGED THE RIM OF THE LIGHT CONNECTOR/BUTTON OF THE STORZ HANDLE. THE USE OF QUESTIONABLY COMPATIBLE GE BLADES WITH STORZ HANDLES MAY REPRESENT A SERIOUS SAFETY CONCERN WHEN THE MARGIN FOR PRODUCT FAILURES SHOULD RARELY EXIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446368 STEELITE DISPOSABLE LARYNOSCOPE BLADE CCW VITAL SIGNS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR DISPOSABLE GE STEELITE LARYNGOSCOPE BLADE WITH A| STORZ BATTERY CHARGED HANDLE.