BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREENLITE DISP MTL MAC 4

    MDR report key: 12579792 · Received October 5, 2021

    Report

    Report Number
    8030121-2021-00032
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 10, 2021
    Report Date
    September 10, 2021
    Product Code
    CCW
    UDI-DI
    14026734626074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE 004551004 RUSCH GREENLITE DISPOSABLE METAL MAC 4 FOR INVESTIGATION. THE SAMPLE WAS RETURNED UNOPENED IN ITS ORIGINAL PACKAGING. VISUAL EXAMINATION REVEALED THE LIGHT GUIDE WAS BROKEN AS THERE WERE SEVERAL BROKEN PIECES IN THE PACKAGING. THE DEVICE HISTORY RECORD OF LOT 2010341 WAS REVIEWED AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. THE RUSCH GREENLITE INSTRUCTIONS FOR USE (IFU) STATES, "DO NOT STERILIZE OR AUTOCLAVE. THIS PRODUCT IS NOT SUITABLE FOR AN MRI ENVIRONMENT. DO NOT USE IF INDIVIDUAL UNIT HAS BEEN OPENED OR DAMAGED. ONLY PERSONNEL ADEQUATELY TRAINED TO PERFORM TRACHEAL INTUBATION SHOULD USE LARYNGOSCOPES." THE REPORTED COMPLAINT OF A BROKEN BLADE PRIOR TO USE IS CONFIRMED. THE SAMPLE WAS RETURNED UNOPENED IN ITS ORIGINAL PACKAGING. THE LIGHT GUIDE WAS BROKEN AND THERE WERE SEVERAL BROKEN PIECES IN THE PACKAGING. BASED ON THE DAMAGE OBSERVED, THE ROOT CAUSE WAS DETERMINED TO BE PACKAGING. A CAPA WAS INITIATED FOR AN INCREASE IN GREENLITE BREAKAGE COMPLAINTS. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED 4 BROKEN BLADES FROM THE SAME LOT. NO PATIENT INVOLEMENT REPORTED.

    Additional Manufacturer Narrative · 1

    QN#(B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED 4 BROKEN BLADES FROM THE SAME LOT. NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1473011 RUSCH GREENLITE DISP MTL MAC 4 LARYNGOSCOPE, RIGID CCW IPN048386 2010341 14026734626074

    Patients

    Seq Age Sex Outcome Treatment
    1