BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREEN RUSCHLITE DISP MTL MAC 4

    MDR report key: 6605310 · Received June 1, 2017

    Report

    Report Number
    8030121-2017-00080
    Event Type
    Malfunction
    Date Received
    June 1, 2017
    Date of Event
    May 18, 2017
    Report Date
    May 18, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE LIGHT PIPE WAS BROKEN. BASED ON THE VISUAL EXAM, THE REPORTED COMPLAINT WAS CONFIRMED. A CAPA WAS OPENED TO ADDRESS THE BREAKAGE ISSUE. A CONCLUSION CODE COULD NOT BE FOUND.

    Additional Manufacturer Narrative · 1

    QN#(B)(4). THE DEVICE INVOLVED IN THIS COMPLAINT HAS NOT BEEN RETURNED TO 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 "THE LIGHT TIP BROKE OFF IN A PATIENT'S MOUTH IN CATH LAB."ALLEGED EVENT REPORTED AS DURING USE. IT WAS REPORTED THERE WAS NO INJURY OR CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "THE LIGHT TIP BROKE OFF IN A PATIENT'S MOUTH IN CATH LAB." ALLEGED EVENT REPORTED AS DURING USE. IT WAS REPORTED THERE WAS NO INJURY OR CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387242 RUSCH GREEN RUSCHLITE DISP MTL MAC 4 LARYNGOSCOPE, RIGID CCW TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1