BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH EQUIPLITE MTL DISP MILL 2

    MDR report key: 6677759 · Received June 29, 2017

    Report

    Report Number
    8030121-2017-00092
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Date of Event
    June 7, 2017
    Report Date
    June 8, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. THE INVESTIGATION INTO THIS COMPLAINT IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "DEVICE FAILED ON INTUBATION. WHEN APPLYING PRESSURE TO BLADE, LIGHT WENT OUT. DIFFERENT HANDLES WERE USED AND BLADE STILL FAILED." ALLEGED MALFUNCTION REPORTED AS OCCURRING DURING USE. NO REPORT OF PATIENT HARM. PATIENT CONDITION REPORTED AS "FINE".

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "DEVICE FAILED ON INTUBATION. WHEN APPLYING PRESSURE TO BLADE, LIGHT WENT OUT. DIFFERENT HANDLES WERE USED AND BLADE STILL FAILED." ALLEGED MALFUNCTION REPORTED AS OCCURRING DURING USE. NO REPORT OF PATIENT HARM. PATIENT CONDITION REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458590 RUSCH EQUIPLITE MTL DISP MILL 2 LARYNGOSCOPE, RIGID CCW TELEFLEX MEDICAL 1609822

    Patients

    Seq Age Sex Outcome Treatment
    1