BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREEN RUSCHLITE DISP MTL MILL 2

    MDR report key: 3970581 · Received June 2, 2014

    Report

    Report Number
    1044475-2014-00166
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 16, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON VISUAL INSPECTION AT RECEIPT OF BLADE THE BROKEN PIPE LIGHT WAS CONFIRMED IN THE PACKAGE. THE HDR (DEVICE HISTORY RECORD) NOT AVAILABLE FOR REVIEW IN THE US. THE COMPLAINT HAS BEEN CONFIRMED. A ROOT CAUSE CANNOT BE ESTABLISHED DUE TO THE LACK OF DETAILED INFO REGARDING THE CIRCUMSTANCES OF THE BREAKAGE. NO CORRECTIVE/PREVENTATIVE ACTIONS ASSIGNED. CONCLUSIONS - NO CODE FOUND FOR CONCLUSION(S) OF THE EVAL. THE COMPLAINT WAS CONFIRMED, BUT THE ROOT CAUSE IS UNK.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE BULB APPEARED DETACHED FROM THE BLADE INSIDE THE PACKAGE. NO REPORT OF PT HARM/INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322179 RUSCH GREEN RUSCHLITE DISP MTL MILL 2 LARYNGOSCOPE BLADE CCW TELEFLEX 1312422

    Patients

    Seq Age Sex Outcome Treatment
    1