BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® EMG - ENDOTRACHEAL TUBE

    MDR report key: 5286979 · Received December 10, 2015

    Report

    Report Number
    1045254-2015-00423
    Event Type
    Injury
    Date Received
    December 10, 2015
    Date of Event
    November 16, 2015
    Report Date
    November 17, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ANALYSIS INDICATES 1 UN-SEALED SAMPLE, PART NUMBER 8229307, FROM LOT NUMBER 0209062710 RECEIVED. THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE. VISUALLY, 3 OF THE 4 ELECTRODE WIRES WERE BENT OUTWARD PUNCTURING THROUGH THEIR RESPECTIVE LUMEN AND CUFF, WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. A PORTION OF THE CUFF WAS CONSISTENT WITH BEING CUT OFF (AND NOT RETURNED), WHICH LIKELY OCCURRED AFTER THE EVENT IN ORDER TO FURTHER OBSERVE THE MALFUNCTION. WHEN VIEWED UNDER MAGNIFICATION, THERE WERE MICRO-SCRATCHES ON 2 OF THE 4 ELECTRODE WIRES AT THE BLUE BAND AND 1 OF THE 2 WAS BENT. THE FINAL ASSEMBLY INSTRUCTIONS, INSTRUCT THE ASSEMBLER NOT TO BEND THE TUBE DURING (ELECTRODE) WIRE INSERTION AND TO VERIFY 100% THAT THE CUFF STAYS INFLATED AFTER HARNESSING. THE INSTRUCTIONS ALSO STATE, TO VISUALLY VERIFY ALL FOUR ELECTRODE WIRES DO NOT POKE THROUGH SIDES OF LUMEN, MAIN TUBE SHAFT, CUFF, OR THROUGH SIDES OF LUMENS, INCLUDING UNDER THE CUFF. THE CUSTOMER ADMITTEDLY INDICATED THAT THERE WAS NO ISSUE WITH THE DEVICE PRIOR TO USE AND THE MALFUNCTION OCCURRED DURING USE. THE COMPLAINT WAS CONFIRMED FOR THE ALLEGED MALFUNCTION (WIRE PUNCTURED CUFF). BASED ON THE AVAILABLE EVIDENCE AND INFORMATION, THE MOST LIKELY UNDERLYING CAUSE IS CONSISTENT WITH MISHANDLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR CHECKED THE EMG ENDOTRACHEAL TUBE PRIOR TO USE AND FOUND NO ISSUES. DURING THE SURGERY, A WIRE PUNCTURED THE CUFF AND PATIENT'S THROAT. THE PATIENT EXPERIENCED A MASSIVE HEMORRHAGE. THE DOCTOR QUICKLY REMOVED THE EMG TUBE AND SUTURED THE PATIENT'S THROAT. THE PATIENT'S CURRENT STATUS IS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817752 NIM® EMG - ENDOTRACHEAL TUBE STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8229307 0209062710

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Required Intervention