BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® PROBE

    MDR report key: 4763557 · Received May 11, 2015

    Report

    Report Number
    1045254-2015-00159
    Event Type
    Malfunction
    Date Received
    May 11, 2015
    Date of Event
    April 15, 2015
    Report Date
    April 15, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K934426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: (1) 7.0MM ID NIM TRIVANTAGE EMG TUBE (8229707); LOT: 0209406571; MANUFACTURED: MARCH 26, 2015; USE BY DATE: MARCH 25, 2019; RETURNED TO MEDTRONIC: (B)(4) 2015; 510K: K112686. (B)(4). IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, BOTH DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION AND REPAIR (DETAILED AS FOLLOWS): (B)(4) ¿ ANALYSIS FOUND THE CONNECTOR INSIDE THE HANDLE WAS ALIGNED WITH THE INSERTION HOLE, AND THERE WAS NO PHYSICAL DAMAGE TO THE HANDLES. THE RESISTANCE OF THE TIP, HANDLE, AND OVERALL ASSEMBLY WERE AS FOLLOWS: PROBE TIP - 0.8 OHM, HANDLE - 0.9 OHMS, AND ASSEMBLY - 1.5 OHMS...RESISTANCE SHOULD MEASURE LESS THAN 3.3 OHMS, VERIFYING AN IN-SPEC CONDITION. NO FAULT OR OUT OF SPECIFICATION CONDITIONS WERE FOUND WITH THIS DEVICE OR ITS COMPONENTS. (B)(4) ¿ ANALYSIS FOUND BIOLOGICAL CONTAMINATION AND A SUBSTANCE CONSISTENT WITH MUCOUS ON THE TUBE. THERE WERE NO SIGNS OF PHYSICAL DAMAGE OR ANOMALIES IN THE CONSTRUCTION OF THE DEVICE, AND THERE WERE NO CRACKS IN THE ELECTRODE CONTACTS WHICH INCLUDES TESTING THE GROUND ELECTRODES FOR ABNORMALITIES. THE RESISTANCE OF THE ELECTRODES FROM END TO END WERE AS FOLLOWS: RED (W/WHITE BAND) 35.4 OHMS; RED 15.1 OHMS, BLUE (W/WHITE BAND) 23.9 OHMS; AND BLUE 18.4 OHMS...EACH LESS THAN 200 OHMS, INDICATING NO OPEN CIRCUITS AND NO OUT OF SPECIFICATION CONDITIONS. THERE WERE NO SHORTS BETWEEN CIRCUITS AND NO INTERMITTENT BEHAVIOR WHILE MANIPULATING THE TUBE AND WIRES. END TO END RESISTANCE FOR THE GREEN ELECTRODE MEASURED 2.0 OHMS (<(><<)>2.5OHMS); RED/WHITE ELECTRODE MEASURED 1.8 OHMS (<(><<)>2.5OHMS)...READINGS ARE WITHIN SPECIFICATION. NO FAULT OR OUT OF SPECIFICATION CONDITIONS WERE FOUND WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ¿NEGATIVE STIM RESPONSE¿ WAS RECEIVED WHEN STIMULATING AN ¿INTACT NERVE¿ WITH A STANDARD PRASS TIP INCREMENTING PROBE INTRAOPERATIVELY, DURING A THYROIDECTOMY. HOWEVER, THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITH NO REPORT OF PATIENT IMPACT OR INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306421 NIM® PROBE STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8225825 0209460835

    Patients

    Seq Age Sex Outcome Treatment
    1