BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREEN RUSCHLITE DISP MTL MILL 2

    MDR report key: 6490564 · Received April 13, 2017

    Report

    Report Number
    8030121-2017-00055
    Event Type
    Malfunction
    Date Received
    April 13, 2017
    Date of Event
    March 8, 2017
    Report Date
    March 30, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDWATCH# MW5068401. THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. IF THE SAMPLE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS RECEIVED VIA MEDWATCH (MW5068401). THE MEDWATCH REFERENCES TWO SEPARATE ISSUES: BREAKAGE AND LIGHT FLICKERING. THIS MDR REFERENCES THE LIGHT FLICKERING ISSUE. THE USER FACILITY WAS NOT LISTED ON THE MEDWATCH REPORT, THUS, ADDITIONAL INFORMATION REGARDING THE EVENT COULD NOT BE OBTAINED. THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE COMPLAINT WAS RECEIVED VIA MEDWATCH (MW5068401). THE COMPLAINT IS REPORTED AS: "THE LIGHT SOURCE OCCASIONALLY DOES NOT WORK INTERMITTENTLY DURING LARYNGOSCOPY".

    Description of Event or Problem · 1

    THE COMPLAINT WAS RECEIVED VIA MEDWATCH (MW5068401). THE COMPLAINT IS REPORTED AS: "THE LIGHT SOURCE OCCASIONALLY DOES NOT WORK INTERMITTENTLY DURING LARYNGOSCOPY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272700 RUSCH GREEN RUSCHLITE DISP MTL MILL 2 LARYNGOSCOPE, RIGID CCW TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1