BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH FIBEROPTIC LARYNGOSCOPE HANDLE

    MDR report key: 3190585 · Received June 21, 2013

    Report

    Report Number
    3004365956-2013-00210
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 19, 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. ON (1) HANDLE WAS RECEIVED UNDER THE LOT/SERIAL #073501. THE ONLY VISIBLE SIGN OF DAMAGE ON THIS HANDLE IS THE RETAINER RING AROUND THE LAMP WHICH WILL NOT STAY PROPERLY LOCATED; HOWEVER, THIS RING HAS NO IMPACT ON THE ALLEGED DEFECT. 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 UNREASONABLE FORCE. THE COMPLAINT IS UNCONFIRMED PER FUNCTIONAL TESTING. 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 PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283559 RUSCH FIBEROPTIC LARYNGOSCOPE HANDLE FIBEROPTIC LARYNGOSCOPE HANDLE CCW TELEFLEX MEDICAL

    Patients

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