BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACH TUBE 8229506 CONTACT EMG 6MM

    MDR report key: 3011113 · Received March 14, 2013

    Report

    Report Number
    1045254-2013-00283
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    April 20, 2012
    Report Date
    April 20, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT 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 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. WITHOUT RETURN OF THE DEVICE, IT CANNOT BE DETERMINED WHETHER OR NOT IT FAILED TO MEET SPEC. THE RELATIONSHIP OF THE DEVICE TO THE REPORTED INCIDENT IS UNCLEAR. NOTHING HAS BEEN RETURNED TO THE MFR FOR EVAL - NEITHER THE DEVICE IN QUESTION, APPLICABLE IMAGING FILMS, NOR MEDICAL RECORDS. THE REPORT IS INCONCLUSIVE AS TO THE CAUSE OF THE REPORTED PRODUCT PROBLEM. 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 REPORTING ON A 6MM ELECTROMYOGRAPHIC (EMG) ENDOTRACHEAL TUBE STATED THAT IT "WAS PLACED IN THE PT... NO MONITORING SIGNAL WAS DETECTED FROM THE TUBE. THE TUBE WAS REMOVED AND REPLACED WITH ANOTHER TUBE, THE SECOND TUBE WORKED FINE. "THERE WAS NO SUGGESTION OF PT INJURY. THE DEVICE WAS NOT RETURNED FOR EVAL AND NO FURTHER INFO IS AVAILABLE. THE AVAILABLE INFO INDICATES THAT THE EMG TUBE WAS NOT RESPONDING OR STOPPED RESPONDING, AND THE USER WAS NOT ALERTED BY A SYSTEM ALARM, WARNING SCREEN OR ERROR MESSAGE. THIS HAS THE POTENTIAL TO RESULT IN A FALSE NEGATIVE. FALSE NEGATIVE COULD POTENTIALLY CAUSE INJURY TO THE PT BY FAILING TO IDENTIFY A NERVE. THIS COULD RESULT IN THE SURGEON DAMAGING THE NERVE. MEDTRONIC WILL ASSUME THAT THE USER DID NOT RECEIVE A SYSTEM ALARM, WARNING SCREEN OR ERROR MESSAGE, UNTIL IT IS CONFIRMED THAT THEY DID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108220 ENDOTRACH TUBE 8229506 CONTACT EMG 6MM ETN - STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8229506 0205677056

    Patients

    Seq Age Sex Outcome Treatment
    1