BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACH TUBE 8229980 5PK 8MM EMG FLEX

    MDR report key: 2996215 · Received March 11, 2013

    Report

    Report Number
    1045254-2013-00241
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). G5: 510(K): THIS PRODUCT IS SIMILAR TO K925640. THE PRODUCT HAS NOT BEEN RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVAL: (B)(4) 2013. THE DEVICE WAS RETURNED FOR ANALYSIS BY THE QUALITY ENGINEERING TEAM. THE RETURNED SAMPLE WAS FOUND TO BE ITEM # (B)(4) AS THE SIZE WAS CONFIRMED BY THE STAMPINGS ON THE INFLATION BALLOON, '8.0MM.' THE TUBE WAS COMPARED TO DRAWING 90A1703, TRACHEAL TUBE, REINFORCED PVC, ASSEMBLY, REV H. THIS ITEM HAS A FLEX CIRCUIT WITH NON-WIRE ELECTRODES. THE RESISTANCE WAS MEASURED AS PER DRAWING (B)(4) EMG ET TUBE HARNESS, REV G, NOTE 2 AND 3. 'MAXIMUM RESISTANCE FROM ELECTRODES TO PINS: 20 OHMS.' OPEN CIRCUIT (>20 M OHMS) BETWEEN PINS. MEASUREMENTS WERE TAKEN WITH A FLUKE 21 MULTIMETER, ASSET # (B)(4), CAL DUE (B)(4) 2013. THE RESISTANCE READINGS WERE ERRATIC AND RANGED BETWEEN 115-250 OHMS. THERE WERE VISIBLE CREASES NOTICED ON THE FLEX CIRCUIT TAIL WHICH LIKELY CAUSED THE ERRATIC READINGS. FURTHERMORE, IF THE DEVICE IS DECONTAMINATED BY THE END USER, THEN THE CONDUCTIVITY ON THE ELECTRODES DIMINISHES, WHICH POSSIBLY CONTRIBUTES TO THE ANALYSIS FINDINGS. THE COMPLAINT EVENT WITH RESPECT TO DEVICE FUNCTIONALITY COULD NOT BE CONFIRMED; HOWEVER, THE MOST LIKELY ROOT CAUSE IS RELATED TO HANDLING/MISHANDLING OF THE DEVICE. CONCLUSION - OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL THYROIDECTOMY PROCEDURE THE LEAD ON THE LEFT SIDE OF THE EMG TUBE "DOES NOT COMPLETE CIRCUIT." THE TUBE WAS REPOSITIONED SEVERAL TIMES AND THEN IT WAS REMOVED. THE PATIENT WAS RE-INTUBATED WITH SMALLER EMG TUBE AND THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102207 ENDOTRACH TUBE 8229980 5PK 8MM EMG FLEX STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8229980 0205997970

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention