BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREEN RESCHLITE DISP. MILLER BLADE 2

    MDR report key: 3963210 · Received May 20, 2014

    Report

    Report Number
    1044475-2014-00131
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED AND VISUAL INSPECTION WAS PERFORMED. THE BLADE WAS OBSERVED TO HAVE A BROKEN PLASTIC BASE AND PIPE LIGHT. DIMENSIONAL AND FUNCTIONAL INSPECTIONS OF THE PRODUCT INVOLVED IN THE COMPLAINT WERE NOT CONDUCTED SINCE THE COMPLAINT WAS NOT RELATED TO A DIMENSIONAL AND FUNCTIONAL NONCONFORMITY. A ROOT CAUSE COULD NOT BE ESTABLISHED. THE CIRCUMSTANCES OF THE PACKAGING, SHIPPING AND HANDLING OF THE DEVICE IS UNK; THEREFORE, IT IS UNK IF THIS CONTRIBUTED TO THE REPORTED DEFECT. NO CORRECTIVE PREVENTATIVE ACTIONS WILL BE ASSIGNED. THERE WILL HOWEVER BE CONTINUED MONITORING AND TRENDING RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THERE WERE SEVERAL PIECES OF PLASTIC BROKEN FROM THE BASE OF THE LARYNGOSCOPE. THE REPORTED DEFECT WAS FOUND INSIDE OF THE PACKAGING AND PRIOR TO USE ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298390 RUSCH GREEN RESCHLITE DISP. MILLER BLADE 2 CCW TELEFLEX 1304422

    Patients

    Seq Age Sex Outcome Treatment
    1