BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER FLEX TRACHEAL TUBE, CUFFED

    MDR report key: 245266 · Received October 15, 1999

    Report

    Report Number
    245266
    Event Type
    Injury
    Date Received
    October 15, 1999
    Date of Event
    October 8, 1999
    Report Date
    October 13, 1999
    Manufacturer
    MALLINCKRODT MEDICAL, INC. CRITICAL CARE DIV.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN SURGERY FOR ABLATION OF A LARYNGEAL PAPILLOMA; CO2 LASER OF VOCAL CORDS. A 6.0MM LASER FLEX CUFFED TRACHEAL TUBE, MADE BY MALLINCKRODT MEDICAL USED. HALFWAY THROUGH PROCEDURE (APPROX. 10 MIN.) SURGEON AND ANESTHESIOLOGIST CALLED "FIRE". THE SCRUB NURSE IMMEDIATELY GRABBED A BUCKET OF WATER AND THREW IT ALL OVER THE AREA AND DOWN THE TUBE. IT WAS IMMEDIATELY EXTINGUISHED. THE SURGEON EXAMINED THE PT'S AIRWAY WITH A FLEXIBLE LARYNGOSCOPE AND NO TISSUE DAMAGE WAS NOTED. THE TUBE WAS REMOVED AND THE CUFF AREA WAS CHARRED. IT WAS NOTED THAT ALL MFR RECOMMENDATIONS AND WARNINGS WERE ADHERED TO: THE CUFF WAS LUBRICATED WITH WATER SOLUBLE LUBRICANT AND FILLED WITH SALINE. OXYGEN AT 27%-RECOMMENDED RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER FLEX TRACHEAL TUBE, CUFFED TRACHEAL TUBE - 6.0 BTR MALLINCKRODT MEDICAL, INC. CRITICAL CARE DIV. * 1998-06 1479

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention