BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 2944041 · Received January 31, 2013

    Report

    Report Number
    1045254-2013-00066
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    September 25, 2009
    Report Date
    November 27, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTROMYOGRAPHIC (EMG) ENDOTRACHEAL TUBE IS INTENDED FOR USE AS 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 FLEXIBLE SILICONE ENDOTRACHEAL TUBE WITH AN INFLATABLE CUFF AND IS FITTED THE ELECTRODE 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 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. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. SIMPLE MANEUVERS TO REPOSITION THE TUBE OR PT 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 FILING THIS REPORT AS AN ADVERSE EVENT.

    Description of Event or Problem · 1

    THE MFR HAS CHANGED/IMPROVED THE CRITERIA FOR MAKING MDR DECISIONS. UPON A RETROSPECTIVE REVIEW, THE FOLLOWING EVENT IS NOW BELIEVED TO BE REPORTABLE: A CUSTOMER REPORTING ON A 7MM NIM ENDOTRACHEAL TUBE STATED "DURING A PARATHYROIDECTOMY THE CUFF LEAKED CAUSING THE PHYSICIAN TO REMOVE IT, AND INSERT A STANDARD TUBE." TESTING/REPAIR VERIFIED THE REPORTED EVENT, FINDING "TWO 7 MM TEARS APPROX .5MM APART IN THE CUFF... IT APPEARS THE TEARS ARE FROM A FORCEPS WHICH WERE USED TO GRIP THE CUFF." THERE WAS NO SUGGESTION OF PT INJURY. IF A TUBE REQUIRES REMOVAL AND REPLACEMENT AFTER THE AIRWAY HAS BEEN ESTABLISHED SUCH ACTIONS ARE CONSIDERED AN INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42083 NA ETN-STIMULATOR, NERVE ETN XOMED MFG JACKSONVILLE 8229507 62622300

    Patients

    Seq Age Sex Outcome Treatment
    1