BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACHEAL TUBE 7060350 LASER-SHIELD II

    MDR report key: 3371185 · Received September 26, 2013

    Report

    Report Number
    1045254-2013-00522
    Event Type
    Injury
    Date Received
    September 26, 2013
    Date of Event
    September 3, 2013
    Report Date
    September 3, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    GEX
    PMA / PMN Number
    K901016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED FOR ANALYSIS ON SEPTEMBER 30, 2013. EVALUATION SUMMARY: THE DEVICE WAS EVALUATED BY THE QUALITY ENGINEER. THE CONDITION OF THE DEVICE SHOWED CUSTOMER USE AS THERE WAS PRESENCE OF RESIDUE THROUGHOUT THE WORKING LENGTH OF DEVICE. UPON VISUAL EVALUATION, THE CUFF WAS FOUND TORN AWAY FROM THE TUBE ASSEMBLY. WITHOUT THE CUFF BEING INTACT TO THE TUBE, A LEAK TEST COULD NOT BE PERFORMED AND THEREFORE THE RETURNED DEVICE COULD NOT FULLY EVALUATED FOR THE REPORTED EVENT THE SYRINGE WAS FOUND ATTACHED TO THE INFLATION VALVE AND THERE WAS CONSIDERABLE AMOUNT OF BLUE COLOR FLUID RESIDUE (LIKELY METHLYNE BLUE SOLUTION) INSIDE THE PILLOW OF THE VALVE AND NEAR THE DISTAL END OF TUBE. THERE APPEARED TO BE BROWN COLOR PATCH NOTICED ON THE WHITE TAPE WHICH IS WRAPPED AROUND THE WORKING LENGTH OF THE TUBE ASSEMBLY. THERE WAS ALSO BROWN COLOR RESIDUE FOUND INSIDE THE DISTAL TIP OF THE TUBE. THERE WERE OBVIOUS SCRATCH MARKS AND MINOR PIN HOLES OBSERVED ON THE WHITE TAPE WHICH POSSIBLY OCCURRED DUE TO CONTACT WITH ANOTHER DEVICE DURING INTUBATION OR REMOVAL OF DEVICE. THE REPORTED MALFUNCTION COULD NOT BE CONFIRMED, SINCE THE OVERALL INTEGRITY OF THE DEVICE WAS NOT INTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): PRODUCT EVALUATION: NO ANALYSIS AVAILABLE, DEVICE NOT RETURNED FOR EVALUATION. METHOD: NO TESTING METHODS PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUFF FAILED, RESULTING IN AN EMERGENCY CRICOTHYROTOMY. FURTHER INFORMATION OBTAINED STATES THAT THE CUFF LEAKED DURING THE MICROLARYNGOSCOPY WITH CO2 LASER, CAUSING THE PATIENTS STATS TO DROP INTO THE 40¿S. THE CUFF LEAK WAS DISCOVERED AFTER REMOVING THE TUBE. IT WAS PUT IN USING A GLIDE SCOPE. THE PREVAILING THOUGHT IS THE METHLYNE BLUE SOLUTION CAUSED LARYNGO/BRONCHO SPASM WHICH MADE THEM NOT ABLE TO RE- INTUBATE, RESULTING IN AN EMERGENCY SURGICAL AIRWAY. THE LAST REPORT STATES THAT THE PATIENT IS NOW DOING ¿FINE¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486718 ENDOTRACHEAL TUBE 7060350 LASER-SHIELD II LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC XOMED, INC. 7060350 55892100

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention