BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACHEAL TUBE 8229306 NIM EMG 6MM RE

    MDR report key: 2810016 · Received October 23, 2012

    Report

    Report Number
    1045254-2012-00552
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    November 15, 2011
    Report Date
    November 25, 2011
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING DID NOT CONFIRM THE REPORTED MALFUNCTION: [SUCTION TUBE GOT STUCK INSIDE THE EMG TUBE]. THE ELECTROMYOGRAPHIC (EMG) ENDOTRACHEAL TUBE IS INTENDED FOR USE AS A MEANS OF PROVIDING BOTH AN OPEN AIRWAY FOR PATIENT 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, APPROXIMATELY 30MM., SLIGHTLY SUPERIOR TO THE CUFF. THE ELECTRODES ARE DESIGNED TO MAKE CONTACT WITH THE PATIENT'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 PATIENT'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. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. SIMPLE MANEUVERS TO REPOSITION THE TUBE OR PATIENT ARE NOT CONSIDERED MEDICAL OR SURGICAL INTERVENTION; BUT IF THE TUBE REQUIRES REMOVAL AND REPLACEMENT AFTER THE AIRWAY HAS BEEN ESTABLISHED SUCH ACTIONS ARE CONSIDERED AN INTERVENTION. IN THIS REPORTED EVENT RE-INTUBATION OCCURRED DURING SURGERY, THUS WE ARE FILLING THIS REPORT AS AN ADVERSE EVENT.

    Description of Event or Problem · 1

    THE MANUFACTURER HAS CHANGED/IMPROVED THE CRITERIA FOR MAKING MDR DECISIONS REGARDING ELECTROMYOGRAPHIC (EMG) ENDOTRACHEAL TUBES, PER DISCUSSION WITH OSB. ANY RE-INTUBATION (MEDICAL INTERVENTION) DURING A SURGICAL PROCEDURE IS BELIEVED TO BE A REPORTABLE EVENT, AS EMG ENDOTRACHEAL TUBES PROVIDE AN OPEN AIRWAY AS WELL AS MONITORING FOR EMG ACTIVITY. A RETROSPECTIVE REVIEW FOUND THE FOLLOWING EVENT: A CUSTOMER REPORTED THAT "DURING THE OPERATION, BECAUSE THE PATIENT SECRETED TOO MUCH SALIVA, AN ANESTHETIST USED A SUCTION TUBE TO CLEAN THE SALIVA. HOWEVER, WHEN THE ANESTHETIST TRIED TO PULL OUT THE SUCTION TUBE, THE SUCTION TUBE GOT STUCK WITH THE ENDOTRACHEAL TUBE ACCIDENTALLY. THUS, THE ANESTHETIST REMOVED THIS ENDOTRACHEAL TUBE WITH THE SUCTION TUBE TOGETHER AND INTUBATED A NEW ENDOTRACHEAL TUBE." THIS RE-INTUBATION OCCURRED INTRAOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTRACHEAL TUBE 8229306 NIM EMG 6MM RE ETN - STIMULATOR, NERVE ETN XOMED MFG JACKSONVILLE 8229306 73362000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention