BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJIFILM

    MDR report key: 5161461 · Received October 20, 2015

    Report

    Report Number
    2431293-2015-00010
    Event Type
    Injury
    Date Received
    October 20, 2015
    Date of Event
    August 24, 2015
    Report Date
    September 16, 2015
    Manufacturer
    FUJIFILM OPTICS CO., LTD. SANO FACTORY
    Product Code
    EOQ
    PMA / PMN Number
    K121035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), WAS RECENTLY TOLD BY THE HOSPITAL THAT 7 OUT OF 13 PATIENTS THAT UNDERWENT BRONCHOSCOPY BETWEEN (B)(6) 2015 WERE SHOWN TO HAVE PSEUDOMONAS; FROM (B)(6) 2015, SAMPLES FROM 28 PATIENTS WERE EITHER REPORTED AS NO GROWTH, OR GREW A FAIRLY RANDOM SELECTION OF ORGANISMS, 8 OUT OF 21 PATIENTS GREW SERRATIA BETWEEN (B)(6) 2015. CURRENTLY, NO REPORTS OF PATIENT ILLNESS. HOSPITAL WAS USING ULTRASOUND BRONCHOSCOPE EB-530US FOR ENDOSCOPIC ULTRASOUND PROCEDURES. IT IS IMPORTANT TO NOTE THAT NO BACTERIUM WAS FOUND IN TESTING OF REPROCESSED SCOPES. BACTERIUM WAS ONLY DETECTED ON SCOPES AFTER USE IN PROCEDURE, BUT PRIOR TO REPROCESSING. ROOT CAUSE IS CURRENTLY UNKNOWN. DEALER AND FUJIFILM STAFF OBSERVED, DURING FOLLOW-UP VISITS, THAT HOSPITAL STAFF DID NOT FULLY COMPLY WITH FUJIFILM'S REPROCESSING INSTRUCTIONS. FURTHER, AER CONNECTIONS USED BY HOSPITAL MAY NOT BE COMPATIBLE WITH THE ULTRASOUND BRONCHOSCOPE EB-530US. FUJIFILM CANNOT EVALUATE THE TECHNICAL ADEQUACY OF THIS CHOSEN SOLUTION BY THE HOSPITAL; THIS CAN ONLY BE DONE BY THE AER MANUFACTURER. ONE OF THE SUBJECTED ENDOSCOPES WAS SENT TO FUJIFILM AND AN INITIAL INVESTIGATION WAS PERFORMED. IN THE INVESTIGATION, AIR LEAK WAS FOUND FROM THE FORCEPS CHANNEL. IT IS BELIEVED THAT THE FORCEPS TUBING WAS DAMAGED BY TREATMENT ACCESSORIES RESULTING IN AIR LEAKING. ALL CUSTOMERS ARE REQUIRED TO AIR LEAK TEST EACH ENDOSCOPE BEFORE DISINFECTION TO AVOID USE OF SUCH DEVICE IN PROCEDURES. FUJIFILM BELIEVES THAT THIS IS NOT AN ISSUE CAUSED BY DEVICE MALFUNCTION. NO DEVICE ISSUE FOUND. HOWEVER FUJIFILM / AUTHORIZED DEALER WILL PROVIDE IN-SERVICE TRAINING TO THE USER.

    Description of Event or Problem · 1

    FUJIFILM (B)(4) WAS INFORMED BY THE (B)(6) THAT A NUMBER OF PATIENTS TESTED POSITIVE FOR SERRATIA AND PSEUDOMONAS BACTERIA AFTER HAVING AN ENDOSCOPIC ULTRASOUND PROCEDURE. THE ROOT CAUSE IS CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693176 FUJIFILM FLEXIBLE ULTRASONIC BRONCHOSCOPE EOQ FUJIFILM OPTICS CO., LTD. SANO FACTORY EB-530US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other