BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACH TUBE 8229306J NIM EMG 6MM

    MDR report key: 2990965 · Received March 6, 2013

    Report

    Report Number
    1045254-2013-00196
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    ETN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS DEVICE IS CLEARED FOR SALE IN JAPAN ONLY, BUT IS SIMILAR TO DEVICE CLEARED UNDER 510K K925640. PRODUCT WAS DISCARDED BY USER FACILITY. PRODUCT ANALYSIS WAS NOT PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY / PROBABLE ROOT CAUSE OF THE ISSUE APPEARS TO BE RELATED WITH CUSTOMER MISUSE / MISHANDLING OF THE DEVICE. AS PER THE INSTRUCTIONS FOR USE (IFU) 68E4127 REV. B OF THE PRODUCT, IT IS RECOMMENDED FOR THE CUSTOMER TO USE A BITE BLOCK WHEN USING AN EMG TUBE TO PREVENT DAMAGE. A BITE BLOCK WOULD HAVE LIKELY PREVENTED THE PATIENT FROM INADVERTENTLY BITING ONTO THE TUBE AND CAUSING OVERALL DEVICE DAMAGE. IFU ALSO INDICATES THE EMG TUBE IS INDICATED FOR USE WHERE CONTINUOUS MONITORING OF THE NERVES SUPPLYING THE LARYNGEAL MUSCULATURE IS REQUIRED DURING SURGICAL PROCEDURES. THE EMG TUBE IS NOT INTENDED FOR POSTOPERATIVE USE. METHOD - NO TESTING METHODS PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AFTER USING THE EMG ENDOTRACHEAL TUBE DURING THE OPERATION, THE PATIENT WENT TO THE ICU, AND THE PATIENT WAS STILL INTUBATED. IN THE ICU, THE PATIENT BIT THE TUBE SO HARD AND THE INTERNAL METALLIC COIL BECOME UNCOVERED FROM THE TUBE. THE PATIENT SEEMS TO BE UNAFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95442 ENDOTRACH TUBE 8229306J NIM EMG 6MM ETN MEDTRONIC XOMED, INC 8229306J 0205707126

    Patients

    Seq Age Sex Outcome Treatment
    1