BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACH TUBE 8229507 CONTACT EMG 7MM

    MDR report key: 2859699 · Received December 6, 2012

    Report

    Report Number
    1045254-2012-00696
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE BLUE AND RED LEADS EXHIBITED NO VISIBLE DAMAGE. THE ELECTRODES WERE FOUND INSERTED THROUGH THE LUMEN AND WERE ALSO FREE OF DAMAGE. THE ELECTRODES DID NOT APPEAR TO PENETRATE THROUGH THE LUMEN AND/OR THE CUFF AREA. A FUNCTIONAL TEST WAS PERFORMED. THE CUFF WAS INFLATED AND SUBMERGED, AND BUBBLES WERE OBSERVED. THE CUFF APPEARED TO HAVE A PINHOLE CLOSE TO PROXIMAL CIRCUMFERENCE OF THE CUFF. THE DAMAGE WAS MOST LIKELY CAUSED BY A SHARP INSTRUMENT BEFORE OR DURING THE PROCEDURE. THE CUSTOMER COMPLAINT WAS CONFIRMED FOR DEVICE LEAKAGE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. THIS EVENT IS FILED AS A SERIOUS INJURY, DUE TO THE REINTUBATION OF THE PATIENT. (B)(4). THE DEVICE WAS RETURNED, EVALUATION HAS NOT YET BEEN COMPLETED. THE FOLLOWING METHOD AND RESULTS CODE WERE NOT IN OUR GCH SYSTEM: METHOD: NO TESTING METHODS PERFORMED (NOT AVAILABLE IN GCH). RESULT: RESULTS PENDING COMPLETION OF EVALUATION (NOT AVAILABLE IN GCH).

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC THAT DURING A RIGHT SUBTOTAL THYROIDECTOMY, IT WAS REALIZED THAT AN ENDOTRACHEAL TUBE HAD AN AIR LEAK IN THE CUFF. THE TUBE HAD TO BE SWITCHED OUT AND THE PATIENT HAD TO BE REINTUBATED. THE ANESTHETIST REPORTEDLY CHECKED THE INTEGRITY OF THE CUFF PRIOR TO INTUBATION. THE LEAK REPORTEDLY TOOK PLACE IMMEDIATELY AFTER INTUBATION. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTRACH TUBE 8229507 CONTACT EMG 7MM STIMULATOR, NERVE ETN XOMED MFG JACKSONVILLE 8229507 0205991339

    Patients

    Seq Age Sex Outcome Treatment
    1 Other