BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE 8229306 NIM EMG 6MM RE

    MDR report key: 3011103 · Received March 14, 2013

    Report

    Report Number
    1045254-2013-00284
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    June 5, 2012
    Report Date
    June 21, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. THE ELECTROMYOGRAPHIC (EMG) ENDOTRACHEAL TUBE IS INTENDED FOR USE AS A MEANS OF PROVIDING BOTH AN OPEN AIRWAY FOR PT VENTILATION AND FOR INTRAOPERATIVE MONITORING OF EMG ACTIVITY OF THE LARYNGEAL MUSCULATURE DURING SURGERY WHEN CONNECTED TO A MULTI-CHANNEL EMG NEUROMONITORING DEVICE. THE EMG ENDOTRACHEAL TUBE IS A FLEXIBLE SILICONE ENDOTRACHEAL TUBE WITH AN INFLATABLE CUFF AND IS FITTED WITH ELECTRODES ON THE MAIN SHAFT OF THE ENDOTRACHEAL TUBE, WHICH ARE EXPOSED ONLY FOR A SHORT DISTANCE, APPROX 30MM, SLIGHTLY SUPERIOR TO THE CUFF. THE ELECTRODES ARE DESIGNED TO MAKE CONTACT WITH THE PT'S VOCAL CORDS TO FACILITATE EMG MONITORING OF THE VOCAL CORDS DURING SURGERY WHEN CONNECTED TO AN EMG MONITORING DEVICE. BOTH THE TUBE AND THE CUFF ARE MANUFACTURED FROM MATERIAL THAT ALLOWS THE TUBE TO READILY CONFORM TO THE SHAPE OF THE PT'S TRACHEA WITH MINIMAL TRAUMA TO TISSUES. THE EMG ENDOTRACHEAL TUBE IS PACKAGED AS A STERILE SINGLE-USE DEVICE. NERVE MONITORS ARE MANDATORY FOR USE WITH THE EMG ENDOTRACHEAL TUBE. THERE ARE MANY NON-DEVICE RELATED ISSUES THAT CAN BLOCK A COMPLETED ELECTRICAL CIRCUIT OR INHIBIT A RESPONSE: SUCH AS PARALYTIC ANESTHETIC; NONCONDUCTIVE/DRY TISSUES, OR A NERVE FATIGUED BY OVER STIMULATION. IN ADDITION, DAMAGE TO THE DEVICE OR MISUSE CAN LEAD TO A DEVICE MALFUNCTION. WHEN SUCH SITUATIONS OCCUR, THE SURGEON CAN FALSELY MISINTERPRET THE INFO AS A NEGATIVE. WHEN INFO SUGGESTS THAT THE NIM EQUIPMENT HAD THE POTENTIAL TO CAUSE PT INJURY IT IS ASSUMED THAT THE FAILURE MAY GO UNDETECTED. THEREFORE, WITHOUT INFO TO REASONABLY SUGGEST SERIOUS INJURY, OR THAT MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE SERIOUS INJURY, WE ARE FILING THIS REPORT AS A PRODUCT PROBLEM. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    THE MFR HAS REFINED THE CRITERIA FOR MAKING MDR DECISIONS. UPON A RETROSPECTIVE REVIEW, THE FOLLOWING EVENT IS NOW BELIEVED TO BE REPORTABLE. A CUSTOMER RETURNED A 6MM ELECTROMYOGRAPHIC (EMG) ENDOTRACHEAL TUBE STATING "AFTER THE ANESTHETIST INSERTS TUBE, DISCOVERY THE AIR LEAKAGE PHENOMENON." THERE WAS NO SUGGESTION OF PT INJURY. IT IS UNCLEAR WHETHER OR NOT THE PT WAS REINTUBATED. THE DEVICE WAS NOT RETURNED FOR EVAL AND NO FURTHER INFO IS AVAILABLE. THE AVAILABLE INFO INDICATES THAT THERE WAS A CUFF LEAK DURING THE PROCEDURE. THIS IS IN REFERENCE TO THE AIR SYSTEM OF THE CUFF AND PILLOW (INFLATION LUMEN). SMALL UNDETECTED CUFF LEAKS (SUCH AS PIN HOLES OR PUNCTURES BY A LEAD WIRE) HAVE RESULTED IN INTRAOPERATIVE CUFF DEFLATION. INTRAOPERATIVE CUFF DEFLATION AFFECTS THE VENTILATION OF THE PT. IF REINTUBATION IS REQUIRED THAT CONSTITUTES MEDICAL INTERVENTION AND MAKES THIS A SERIOUS INJURY. IF NO FURTHER INFO IS PROVIDED OR CAN BE OBTAINED, MEDTRONIC WILL CONSERVATIVELY ASSUME THAT THE REPORTED LEAK IS MALL AND POSSIBLY UNDETECTABLE IN NATURE AND REQUIRED REINTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108218 ENDOTRACHEAL TUBE 8229306 NIM EMG 6MM RE ETN - STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8229306 0205324249

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR