BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACHEAL TUBE 7060300 LASER-SHIELD II

    MDR report key: 1916785 · Received December 8, 2010

    Report

    Report Number
    1045254-2010-00063
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 12, 2010
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    BSK
    PMA / PMN Number
    K901016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS BEING USED FOR TREATMENT AND NOT FOR DIAGNOSIS THE PRODUCT INSTRUCTIONS INCLUDE WITH EACH LASER ET TUBE STATES IN THE WARNING SECTION: "DO NOT IMPACT THE LASER SHIELD II WITH A LASER BEAM. THE REFLECTIVE ALUMINUM WRAPPING IS EXPOSED AND ENERGY OF THE LASER MAYBE REFLECTED ONTO THE PATIENT'S TISSUE CAUSING INJURY."

    Description of Event or Problem · 1

    INFORMATION PROVIDED BY MEDWATCH FORM (B)(4) RECEIVED FROM THE CUSTOMER CONTACT REPORTED UPON REMOVAL FROM THE ENDOTRACHEAL TUBE, IT WAS DISCOVERED THE BALLOON HAD DEFLATED AT SOME TIME DURING THE PROCEDURE (LARYNGOSCOPY) DIRECT MICRO WITH A CO2 LASER AND BIOPSY) DUE TO A TEAR IN THE BALLOON. THE PHYSICIAN WAS CONCERNED PARTICULATES FROM THE INCIDENT MAY HAVE FALLEN INTO THE PATIENT'S BRONCHIAL. A VISUAL OBSERVATION OF THE RETURNED PRODUCT HAD SHOWN A DIAGONAL GASH ACROSS THE LENGTH OF THE CUFF. A MAGNIFIED VIEW OF THE GASH INDICATED BURNED DEBRIS IN THE OPENED AREA AND ON THE EDGES OF THE GASH. THIS WOULD INDICATE A LASER HAD STRUCK THE CUFF. IN A FOLLOW UP CONVERSATION WITH THE CUSTOMER CONTACT STATED THE PATIENT WAS X-RAYED AND THE IMAGE "LOOKED GOOD." IT WAS FURTHER STATED THERE WAS, "NO ISSUE WITH THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTRACHEAL TUBE 7060300 LASER-SHIELD II CUFF, TRACHEAL TUBE, INFLATABLE BSK MEDTRONIC XOMED INC. 7060300 67866800

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention