BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJINON

    MDR report key: 2177872 · Received July 1, 2011

    Report

    Report Number
    2431293-2011-00003
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 3, 2011
    Report Date
    July 1, 2011
    Manufacturer
    FUJIFILM CORP.
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER NOTIFIED FUJINON OF AN INCIDENT INVOLVING A FUJINON EB-470T BRONCHOSCOPE. THE SCOPE WAS SHIPPED TO FUJINON IN A RED BIOHAZARD BAG. THE SCOPE COULD NOT BE REPROCESSED BECAUSE, THE DISTAL END PORTION ON THE INSERTION TUBE WAS DAMAGED AND ENTIRELY OPENED. FUJINON EXAMINED THE SUBJECT SCOPE CLOSELY AND FOUND THAT THE INSERTION TUBE HAD GOTTEN STUCK INSIDE THE TRACHEAL TUBE. THE TRACHEAL TUBE HAD IDENTIFYING MARKS "(B)(4)." THE SCOPE WAS RETURNED WITH THE TRACHEAL TUBE INTACT. THE OUTER DIAMETER OF THE SCOPE IS 5.9 MM AND THE INNER DIAMETER OF THE TRACHEAL TUBE IS 8 MM. THERE IS A POSSIBILITY FOR FRICTION TO OCCUR BETWEEN THE SCOPE AND THE TRACHEAL TUBE. THE FOLLOWING DEFECTS ON THE SUBJECT SCOPE WERE ALSO OBSERVED, THESE APPEARED ON THE DISTAL END OF THE INSERTION SECTION: TORN BENDING RUBBER. BROKEN LIGHT GUIDE, BENDING SECTION WAS SEPARATED FROM THE DISTAL TIP AND A BROKEN CHARGED COUPLE DEVICE (CCD) WHICH WAS SEPARATED FROM THE OBJECTIVE LENS. BASED ON THE CONSTRUCTION OF THE INSERTION PORTION AND DEFECTS OBSERVED, IT IS LIKELY THAT THE DISTAL TIP WAS CAUGHT AT THE TIP OF THE TRACHEAL TUBE, THEN THE PHYSICIAN APPLIED EXCESSIVE FORCE TO REMOVE IT. IT IS POSSIBLE THAT DUE TO THE FRICTION BETWEEN THE SCOPE AND THE TRACHEAL TUBE, AND PHYSICIAN APPLYING EXCESSIVE FORCE TO REMOVE THE SCOPE, THIS CAUSED DAMAGE TO THE SCOPE. THE BLACK MATERIAL THE PHYSICIAN NOTICED ON HIS HANDS IS MOST LIKELY MOLYCOAT. MOLYCOAT IS MOLYDENUM POWDER WHICH IS USED AS A LUBRICANT INSIDE THE INSERTION PORTION OF THE SCOPE. THIS IS A UNIQUE INCIDENT. THIS IS THE FIRST INCIDENT OF THIS NATURE REPORTED TO FUJINON. NO OTHER SIMILAR INCIDENCES INVOLVING THIS SN OR MODEL.

    Description of Event or Problem · 1

    DURING BRONCHOSCOPY PROCEDURE, PHYSICIAN WENT IN THE LEFT SIDE OF LUNG TO WASH WITH NO DIFFICULTIES. THE PHYSICIAN THEN PULLED BACK TO GO INTO THE RIGHT LUNG, AS THE PHYSICIAN PULLED BACK, HE NOTICED DIFFICULTY PULLING THE SCOPE BACK WHICH SEEMED TO BE GETTING CAUGHT, HE WAS UNABLE TO PULL THE SCOPE OUT OF THE ET TUBE. THE PHYSICIAN THEN NOTICED BLACK ALL OVER HIS HANDS, STOPPED PULLING AND INTUBATED THE PT TO GET THE SCOPE OUT. THE SCOPE APPEARED TO HAVE BUCKLED IN ON ITSELF. THE TIP OF THE SCOPE WAS EXPOSED. THE OUTER SHEATH HAD DISINTEGRATED LEAVING THE SCOPE FIBERS EXPOSED AND THE ET TUBE ADHERED TO THE SCOPE. ON THE SCREEN, IT APPEARED TO HAVE PARTICLES FROM THE SCOPE IN THE LUNGS. THE PT WAS RE-INTUBATED TO CONTINUE THE PROCEDURE. THE PHYSICIAN LAVAGED THE PT'S LUNGS UNTIL ALL PARTICLES WERE REMOVED FROM THE LUNGS AND A CLEAR PICTURE ON THE SCREEN WAS OBTAINED. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER UNIT. HE HAS SINCE SEEN THE PT SINCE THIS INCIDENT AND HE REMAINS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUJINON BRONCHOSCOPE EOQ FUJIFILM CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention