BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACH TUBE 8229965 5PK 6.5MM EMG FLX

    MDR report key: 3011132 · Received March 14, 2013

    Report

    Report Number
    1045254-2013-00281
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    July 12, 2012
    Report Date
    July 13, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TWO SAMPLES OF 6.5MM EMG ENDOTRACHEAL TUBES WERE RETURNED AND TESTED. THE CHANNELS WERE TESTED FOR RESISTANCE AND THE READINGS INDICATED AN IN SPEC CONDITION WITH NO OTHER DAMAGE OR DEFECT OBSERVED. THERE WAS AN OPEN (NO SHORT CIRCUIT) BETWEEN CHANNELS REQUIRED PER PRINT. NOTE: SAMPLE 1 STILL HAD THE WHITE TAPE INTACT THAT HOLD THE WIRES TOGETHER AND NO OTHER SIGNS OF USE. BASED ON THE OBSERVATION, THE MOST LIKELY UNDERLYING CAUSE FOR THIS EVENT IS CONSISTENT WITH MISUSE OF THE DEVICE [MISPLACEMENT DURING INTUBATION WHEREAS 1 CHANNEL WAS NOT MAKING CONTACT WITH A VOCAL FOLD]. THE ELECTROMYOGRAPHIC (EMG) ENDOTRACHEAL TUBE IS INTENDED FOR USE AS A MEANS OF PROVIDING BOTH AN OPEN AIRWAY FOR PT VENTILATOR 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. IT SHOULD BE NOTED THAT ARE MANY NON-DEVICE RELATED ISSUES THAT CAN BLOCK A COMPLETED ELECTRICAL CIRCUIT OR INHIBIT A RESPONSE: SUCH AS THE USE OF PARALYTIC ANESTHESIA AGENTS; NON-CONDUCTIVE/DRY TISSUES, OR A NERVE FATIGUED BY OVERSTIMULATION. IN ADDITION, DAMAGE TO THE DEVICE OR MISUSE CAN LEAD TO A DEVICE MALFUNCTION. WHEN SUCH SITUATION OCCUR, THE SURGEON CAN FALSELY MISINTERPRET THE INFO AS A NEGATIVE, I.E. THAT A NERVE IS NOT PRESENT WHEN IT REALLY IS PRESENT. 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 6.5MM ELECTROMYOGRAPHIC (EMG) ENDOTRACHEAL TUBE STATING THAT THERE WAS "NO SIGNAL ON ONE CHANNEL. CHANGE OF [ELECTRODES] HAD NO POSITIVE EFFECT. TUBE WAS REPLACED WITH A NEW ONE. AGAIN "NO SIGNAL ON ONE CHANNEL." THERE WAS NO ALLEGATION OF PT INJURY. TESTING/REPAIR COULD NOT CONFIRM THE REPORTED EVENT. 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 NEGATIVES 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
    108426 ENDOTRACH TUBE 8229965 5PK 6.5MM EMG FLX ETN - STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8229965 0205854237

    Patients

    Seq Age Sex Outcome Treatment
    1