BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACHEAL TUBE 8229306 NIM EMG 6MM RE

    MDR report key: 3071243 · Received April 22, 2013

    Report

    Report Number
    1045254-2013-00344
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE INITIAL REPORTER. THE PROCEDURE WAS FOR A THYROIDECTOMY. THE EMG TUBE HAD TO BE REPOSITIONED AT LEAST TWICE DURING INTUBATION. IT IS UNCERTAIN IF THE PATIENT WAS ACTUALLY PRICKED BY THE WIRE FROM THE TUBE BUT WHEN THE EMG TUBE WAS REMOVED POST-OPERATIVELY, THERE WAS BLOOD ON IT. THE PATIENT WAS REPORTED TO BE FINE WHEN RELEASED HOME. THE CUSTOMER STATED THEY STILL HAD THE DEVICE AVAILABLE FOR RETURN AND EVALUATION. THE DEVICE WAS RETURNED AND EVALUATED BY THE QUALITY ENGINEERING TEAM. UPON EVALUATION OF THE DEVICE, ONE OF THE FOUR ELECTRODE WIRES WAS FOUND POKING THROUGH THE CUFF ASSEMBLY. THE WIRE WAS SEVERELY BENT AT ITS DISTAL END WHICH INDICATED CUSTOMER MANIPULATION / EXCESSIVE HANDLING / USE OF THE DEVICE. THE CUFF WAS REMOVED TO CLOSELY OBSERVE THE WIRE LUMEN. IT WAS FOUND THAT THE ELECTRODE WIRE HAD TORN THROUGH THE WIRE LUMEN AND WAS SEVERELY BENT AND ORIENTING UPWARDS. NO OTHER DAMAGE WAS NOTICED ON THE WORKING LENGTH OF THE TUBE OR THE ELECTRODES. AS PART OF INVESTIGATION, THE DISTAL END OF THE TUBE WAS BENT / FLEXED TO SEE HOW THE OTHER WIRES REACT TO EXCESSIVE HANDLING / BENDING, IT WAS FOUND THAT WITH TOO MUCH EXCESSIVE FORCE, THE WIRE WOULD PUNCTURE THROUGH THE LUMEN AND LIKELY POKE THROUGH THE CUFF. THE REPORTED COMPLAINT WAS CONFIRMED. THE PRIMARY ROOT CAUSE IS LIKELY THE RESULT OF EXCESSIVE USE AND/OR MANIPULATION BY THE USER. METHOD - STRENGTH TESTING. RESULTS - STRESS PROBLEM.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS DISCARDED BY THE USER FACILITY. METHOD - NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE INITIAL REPORTER. THE PROCEDURE WAS FOR A THYROIDECTOMY. THE EMG TUBE HAD TO BE REPOSITIONED AT LEAST TWICE DURING INTUBATION. IT IS UNCERTAIN IF THE PATIENT WAS ACTUALLY PRICKED BY THE WIRE FROM THE TUBE BUT WHEN THE EMG TUBE WAS REMOVED POST-OPERATIVELY, THERE WAS BLOOD ON IT. THE PATIENT WAS REPORTED TO BE FINE WHEN RELEASED HOME. THE CUSTOMER STATED THEY STILL HAD THE DEVICE AVAILABLE FOR RETURN AND EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE ONE OF THE WIRES FROM THE EMG TUBE POKED THROUGH THE BALLOON AND POTENTIALLY NICKED THE PATIENT'S THROAT. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171529 ENDOTRACHEAL TUBE 8229306 NIM EMG 6MM RE STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8229306 0205719546

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Other