BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREEN RUSCHLITE DISP MTL MAC 4

    MDR report key: 6540880 · Received May 3, 2017

    Report

    Report Number
    8030121-2017-00076
    Event Type
    Malfunction
    Date Received
    May 3, 2017
    Date of Event
    April 18, 2017
    Report Date
    April 19, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT, THE BLADE WAS INSPECTED VISUALLY TO SEE IF THERE WERE ANY SIGNS OF ABUSE/MISUSE/DAMAGE THAT COULD BE DETECTED. THE PIPE LIGHT WAS OBSERVED TO BE BROKEN OFF AND LOOSE IN THE RETURN PACKAGE. THE PIPE LIGHT WAS BROKEN OFF WHERE THE GREEN SHEATHING BEGINS. THE COMPLAINT HAS BEEN CONFIRMED. ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. A CAPA HAS BEEN OPENED TO ADDRESS PIPE LIGHT BREAKAGE ON GREEN RUSCH LIGHT DISPOSABLE BLADES. A CONCLUSION CODE COULD NOT BE FOUND. THE COMPLAINT IS CONFIRMED HOWEVER THE ROOT CAUSE IS NOT KNOWN.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "WHEN USING THE GREEN RUSCH LITE MAC 4 BLADE WHERE THE GREEN TUBE CAME OFF AND ENDED UP IN THE PATIENTS THROAT". IT WAS REPORTED THERE WAS NO PATIENT INJURY OR CONSEQUENCE. PATIENT CONDITION REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322203 RUSCH GREEN RUSCHLITE DISP MTL MAC 4 LARYNGOSCOPE, RIGID CCW TELEFLEX MEDICAL 1505342

    Patients

    Seq Age Sex Outcome Treatment
    1