BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH TRULED HANDLE, MEDIUM, EUROPE

    MDR report key: 10356224 · Received August 3, 2020

    Report

    Report Number
    8030121-2020-00134
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    July 15, 2020
    Report Date
    July 29, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION AND SENT TO THE MANUFACTURING SITE FOR INVESTIGATION. THE MANUFACTURING SITE REPORTS THAT THE CARTRIDGE WAS "RESPONDING RED AND GREEN LIGHT WHEN IT HAD CONNECTED WITH THE POWER SOURCE LIKE CHARGER WITH ELECTRICITY". THE MANUFACTURING SITE ALSO REPORTS THAT IT WAS OBSERVED THAT THERE WAS A THICK FORMATION INSIDE OF THE INNER CARTRIDGE INDICATING AN INCORRECT STERILIZATION OR CLEANING PROCESS. THE DEVICE HISTORY RECORD OF LOT OF THE SAMPLE RECEIVED (190601) WAS REVIEWED AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. THE MANUFACTURING SITE REPORTS THE "FAILURE CANNOT BE JUSTIFIED AS DURING INVESTIGATION WE NOTICED TRACES OF CHEMICAL /DISINFECTANT ON THE SURFACE ON THE INNER CARTRIDGES AND DEFINITELY DISINFECTANT /CHEMICAL HAD ENTERED ON THE INNER SURFACE AND THERE IS POSSIBILITY THAT DUE TO CHEMICAL EXPOSURE INTERNAL ELECTRICAL CIRCUIT OF LED HAS GOT FUSED. AS PER THE IFU INSTRUCTIONS THE OUTER HANDLE MAY BE AUTOCLAVED OR STERILIZED VIA STERIS OR STERRAD AND THE INNER CARTRIDGE IS NOT SUITABLE FOR STERILIZATION BUT DURING INVESTIGATION WE HAVE TRACES THE CHEMICAL AGENT LAYER ON INNER CARTRIDGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE LED LIGHT DID NOT WORK PRIOR TO PATIENT USE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE LED LIGHT DID NOT WORK PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821969 RUSCH TRULED HANDLE, MEDIUM, EUROPE LARYNGOSCOPE, RIGID CCW TELEFLEX MEDICAL 190301

    Patients

    Seq Age Sex Outcome Treatment
    1