BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREENLITE DISP MTL MAC 4

    MDR report key: 10266879 · Received July 13, 2020

    Report

    Report Number
    8030121-2020-00098
    Event Type
    Malfunction
    Date Received
    July 13, 2020
    Date of Event
    June 25, 2020
    Report Date
    June 26, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE SAMPLE WAS RECEIVED AND RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. THE MANUFACTURING SITE REPORTS THAT NO INVESTIGATION COULD BE PERFORMED AS THE SAMPLE WAS RECEIVED DAMAGED. THE MANUFACTURER ALSO REPORTS THIS PRODUCT FAMILY DOES NOT HAVE A LIGHT SOURCE IN THE BLADE. IT ONLY TRANSMITS THE HANDLE'S LIGHT THROUGH THE BLADE LIGHT GUIDE. THE DEVICE HISTORY RECORD WAS REVIEWED FOR LOT NO. 2002341 AND NO ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WERE NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT REPORTED AS: "DURING THE LARYNGOSCOPY, AS SOON AS THE BLADE WAS PROPERLY IN THE RIGHT POSITION IN THE MOUTH OF THE PATIENT, THE LIGHT BLINKED AND THEN STOPPED. LIKELY IT WAS A BAD CONNECTION BETWEEN THE HANDLE AND THE BLADE." IT WAS REPORTED THERE WAS NO CONSEQUENCE FOR THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT REPORTED AS: "DURING THE LARYNGOSCOPY, AS SOON AS THE BLADE WAS PROPERLY IN THE RIGHT POSITION IN THE MOUTH OF THE PATIENT, THE LIGHT BLINKED AND THEN STOPPED. LIKELY IT WAS A BAD CONNECTION BETWEEN THE HANDLE AND THE BLADE." IT WAS REPORTED THERE WAS NO CONSEQUENCE FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730284 RUSCH GREENLITE DISP MTL MAC 4 LARYNGOSCOPE, RIGID CCW TELEFLEX MEDICAL 2002341

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED.| NONE REPORTED.