BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACHEAL TUBE 7060200 LASER-SHIELD I

    MDR report key: 2544136 · Received April 21, 2012

    Report

    Report Number
    1045254-2012-00206
    Event Type
    Injury
    Date Received
    April 21, 2012
    Date of Event
    February 3, 2012
    Report Date
    March 30, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    BSK
    PMA / PMN Number
    K901016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED. NEITHER APPLICABLE IMAGING FILMS NOR MEDICAL RECORDS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. DEVICE DESCRIPTION- THIS DEVICE IS AN ENDOTRACHEAL TUBE WITH A LASER RESISTANT OVERWRAP OF ALUMINUM AND A FLUOROPLASTIC COVERING THE SILICONE ELASTOMER SHAFT. THE WHITE WRAP AREA, EXCLUDING THE MOST DISTAL 2MM O WHITE WRAPPING, IS LASER RESISTANT. THE SMOOTH, LOW TRAUMATIZING ENDOTRACHEAL TUBE IS FITTED WITH A CUFF DESIGNED TO PROVIDE AN EFFECTIVE TRACHEAL SEAL UNDER MULTIPLE ANATOMICAL VARIATIONS. THE CUFF INFLATION VALVE HAS BEEN EQUIPPED WITH DRY METHYLENE BLUE TO ENABLE THE DETECTION OF CUFF RUPTURES. THE TUBE AND CUFF ARE NON-WETTING, WHICH ALLOWS FOR EASY INSERTION AND REMOVAL AND REDUCES SECRETION ACCUMULATION DURING INTUBATION. THE TUBE IS FLEXIBLE AND ADAPTS EASILY TO CHANGES IN AIRWAY POSITION. THE TUBES ARE PROVIDED STERILE AND INTENDED FOR SINGLE US ONLY. DO NOT USE WITH AND ND: YAG LASER OR ARGON LASER, OR A LASER TYPE OTHER THAN CO2 OR DPT. DO NOT USE ANY CONTACT TIP STYLE LASER DELIVERY INSTRUMENT WITH THIS PRODUCT. DO NOT IMPACT THIS INSTRUMENT WITH A LASER BEAM. THE REFLECTIVE ALUMINUM WRAPPING IS EXPOSED AND ENERGY OF THE LASER BEAM MAY BE REFLECTED ONTO THE PATIENT'S TISSUE CAUSING INJURY. DO NOT CONTACT THE CUFF OR DISTAL END OF THE SHAFT WITH A LASER BEAM OR ELECTROSURGICAL INSTRUMENT. CONTACT MAY CAUSE DEFLATION OF THE CUFF AND RESULT IN COMBUSTION AND FIRE. DO NOT USE SURGICAL LASERS OR ELECTRO OR THERMAL CAUTERY POWER SOURCES IN THE PRESENCE OF ELEVATED OXYGEN LEVELS OR OTHER FLAMMABLE GASSES, OR DAMAGE TO THE TUBE MAY RESULT IN IGNITION AND SERIOUS PATIENT INJURY. DO NOT USE NITROUS OXIDE FOR DILUTION OF OXYGEN. NITROUS OXIDE IS A FLAMMABLE GAS AND MAY RESULT IN IGNITION AND SERIOUS PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: DEVICE EVALUATED BY MFR?: NO EVAL EXPLAIN CODE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE FOLLOWING EVENT WAS NOT REPORTED TO THE MANUFACTURER BUT WAS SUBSEQUENTLY FOUND DURING AN INVESTIGATION OF A SIMILAR EVENT (REPORTED THROUGH MDR #1045254-2012-00124). A VOLUNTARY MEDWATCH ((B)(4)) WAS REPORTED TO THE FDA BY THE USER FACILITY; HOWEVER, THIS REPORT WAS NOT RECEIVED BY THE MANUFACTURER OF THE DEVICE. FURTHER INVESTIGATION COULD NOT BE CONDUCTED AS THE INITIAL REPORTER IS NOT AVAILABLE. THIS REPORT IS BEING SUBMITTED TO AS ACKNOWLEDGMENT OF THE EVENT. THE REPORTED EVENT STATES: "MEDTRONIC LASER-SHIELD II ENDOTRACHEAL TUBE USED FOR DIRECT LARYNGOSCOPY WITH LASER OF A VOCAL CORD LESION. THERE WAS A "POP" AND SMOKE CAME OUT OF PT'S MOUTH WITH FIRE BURNING THE DISTAL PORTION OF THE ENDOTRACHEAL TUBE AND BURNING AIRWAY. SALINE WAS POURED INTO PT'S MOUTH. ENDOTRACHEAL TUBE WAS REPLACED. INSPECTION OF THE LASER-SHIELD II ENDOTRACHEAL TUBE SHOWED A BLUNTING OF THE END OF THE TUBE DISTAL TO THE LASER COATING. THE CUFF WAS MURPHY EYE WERE COMPLETELY MISSING. PT REQUIRED BRONCHOSCOPY AND TRANSFER TO HIGHER LEVEL OF CARE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTRACHEAL TUBE 7060200 LASER-SHIELD I CUFF, TRACHEAL TUBE, INFLATABLE BSK XOMED MFG JACKSONVILLE 7060200 0205255530

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R