BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJINON

    MDR report key: 3063967 · Received March 25, 2013

    Report

    Report Number
    2431293-2013-00002
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    December 1, 2012
    Report Date
    February 15, 2013
    Manufacturer
    FUJINON, INC.
    Product Code
    EOQ
    PMA / PMN Number
    K050907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FMSU WAS INFORMED BY ITS DISTRIBUTOR THAT THEIR CUSTOMER HAD REPORTED POSITIVE GROWTH OF PSEUDOMONAS IN SEVERAL PATIENTS AND TWO FUJINON BRONCHOSCOPES (SNS: (B)(4)). DURING OUR INVESTIGATION FMSU CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION REGARDING THIS EVENT. THE CUSTOMER INFORMED FMSU THAT SEVERAL BAL CULTURES OBTAINED DURING BRONCHOSCOPY PROCEDURES HAD TESTED POSITIVE FOR PSEUDOMONAS. HOWEVER, SUBSEQUENT PATIENT SPUTUM SAMPLES YIELDED NEGATIVE RESULTS. TO THE BEST OF OUR KNOWLEDGE, NO PATIENTS HAVE SHOWN SYMPTOMS OF INFECTION OR HAVE ACTUALLY BEEN INFECTED AS A RESULT OF THEIR BRONCHOSCOPY PROCEDURES. BASED UPON OUR INVESTIGATION THIS SITUATION APPEARS TO BE THAT OF A PSEUDOINFECTION IN WHICH CERTAIN COMPONENTS/PORTION OF THE ENDOSCOPE MAY HAVE INTERMITTENTLY TESTED POSITIVE FOR BACTERIA (VIA THE BAL CULTURES), HOWEVER, THERE WAS NO TRANSFERENCE OF CONTAMINANTS TO A PATIENT. THIS COULD HAVE OCCURRED IF A CERTAIN PORTION OF THE SCOPE OR SCOPE COMPONENT (EX. SUCTION BUTTON) INTENDED FOR THE MOVEMENT OF FLUIDS AWAY FROM THE PATIENT WERE NOT ADEQUATELY REPROCESSED AND/OR THOROUGHLY DRIED. DURING THE COURSE OF OUR INVESTIGATION AND IN-SERVICE AT THE CUSTOMER'S FACILITY, WE DISCOVERED THAT THE USER HAD BEEN REPROCESSING THEIR FUJINON BRONCHOSCOPES AND AER OEM (MEDIVATORS) INSTRUCTIONS. WE BELIEVE THESE REPROCESSING INCONSISTENCIES (USER ERROR) RESULTED IN THE POSITIVE BAL CULTURES. AS A PREVENTATIVE MEASURE, FMSU IN-SERVICED THE CUSTOMER ON (B)(6) 2013 REGARDING THE MANUAL REPROCESSING OF THEIR FUJINON BRONCHOSCOPES/COMPONENTS AND HAS RECOMMENDED THAT THE CUSTOMER CONTACT THEIR AER OEM FOR TRAINING/IN-SERVICING. THE ROOT CAUSE FOR THIS INCIDENT IS USER ERROR. TO DATE, FMSU HAS NOT RECEIVED OTHER REPORTS OF THIS NATURE. THIS REPORT IS BEING SUBMITTED AS MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, FUJIFILM MEDICAL SYSTEMS U.S.A. , INC. WAS INFORMED BY ITS DISTRIBUTOR, THAT THEIR CUSTOMER REPORTED POSITIVE GROWTH OF PSEUDOMONAS IN SEVERAL PATIENTS AND FUJINON BRONCHOSCOPES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121394 FUJINON BRONCHOSCOPE EOQ FUJINON, INC. EB-470S

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDIVATORS CER