BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH FIBEROPTIC LARYNGOSCOPE HANDLE

    MDR report key: 3190578 · Received June 21, 2013

    Report

    Report Number
    3004365956-2013-00202
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 30, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION: FIVE (5) HANDLES WERE RECEIVED UNDER THE LOT/SERIAL #(B)(4). THE HANDLES DO NOT DISPLAY ANY VISIBLE SIGNS OF DAMAGE OTHER THAN LIGHT SUPERFICIAL SCRATCHES THAT WOULD COME FROM NORMAL WEAR AND TEAR. FUNCTIONAL INSPECTION: PER THE ATTACHED PICTURE IN THIS SAP COMPLAINT, THREE DIFFERENT STYLE BLADES (RUSCH DISPOSABLE GREEN LITE MILL 2, SNAP LIGHT MILL 4, AND EMERALD RUSCH MIL 1.5) WERE ATTACHED TO EACH OF THE FIVE SUSPECTED DEFECTIVE HANDLES AND REMOVED WITHOUT ANY REASONABLE FORCE. ROOT CAUSE: NO FUNCTIONAL ISSUES FOUND.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: THE CUSTOMER ALLEGES THAT THEY ARE UNABLE TO REMOVE THE BLADE FROM THE HANDLE WITHOUT EXTRAORDINARY EFFORT. THE HANDLES ARE USED WITH SUNMED, PHILLIPS AND RUSCH BLADES. THE END-USER STATES THAT THE ISSUE OCCURS OVER TIME. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283977 RUSCH FIBEROPTIC LARYNGOSCOPE HANDLE FIBEROPTIC LARYNGOSCOPE HANDLE CCW TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 SUNMED BLADES| RUSCH BLADES| PHILLIPS BLADES