BEUDAMED
    FDA Adverse Event Summary report: N

    FUJINON

    MDR report key: 4101496 · Received August 27, 2014

    Report

    Report Number
    2431293-2014-00005
    Date Received
    August 27, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 27, 2014
    Manufacturer
    FUJIFILM OPTICS CO., LTD. MITO FACTORY
    Product Code
    FDA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MICROMED SALES REPRESENTATIVE ADVISED THE CUSTOMER TO CONTACT THE ASP AER MANUFACTURER DIRECTLY TO VERIFY THAT THE FACILITY WAS CORRECTLY FOLLOWING AER MANUFACTURER INSTRUCTIONS IN THE REPROCESSING OF FUJIFILM ENDOSCOPES. THE CUSTOMER PROVIDED NO DETAILS ON THE DURATION OR DATES FOR THE SUSPECT ENDOSCOPE REPROCESSING. FUJIFILM FOLLOWED UP WITH (B)(6), THE SURGICAL DIRECTOR, TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS INCIDENT. MS. (B)(6) INFORMED FUJIFILM THAT THERE WERE NO PATIENT INCIDENCES ASSOCIATED WITH THE INCORRECT REPROCESSING DURING THIS TIME PERIOD. MS. (B)(6) STATED THAT SHE HAD VERIFIED WITH THEIR THIRD PARTY SERVICE PROVIDER AND THE (B)(4) AER REPRESENTATIVE THAT THERE WAS SUFFICIENT CHEMICAL EXPOSURE TO THE BIOPSY CHANNEL TO NOT POSE RISK TO PATIENT SAFETY. ENDOSCOPE MODELS EG-530WR, EC-530HL2 AND EC-530LS2 WERE IDENTIFIED BY THE CUSTOMER AS BEING INVOLVED DURING THIS EVENT TIME PERIOD. THE DEVICES DESCRIBED IN THIS REPORT HAVE NOT BEEN RETURNED TO FUJIFILM FOR EVALUATION. THE DEVICES REMAIN IN USE BY THE FACILITY. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE INCORRECT REPROCESSING IS USER ERROR. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED A MICROMED LLC (FUJIFILM CONTRACTED SALES/SERVICE PROVIDER) SALES REPRESENTATIVE TO INQUIRE WHETHER PROPER HIGH-LEVEL DISINFECTION OF FUJIFILM ENDOSCOPES WITH AN ASP AUTOMATIC ENDOSCOPE REPROCESSOR (AER) HAD BEEN COMPROMISED DUE TO INCORRECT CHANNEL CONNECTIONS. THE CUSTOMER STATED THAT ITS STAFF HAD FAILED TO CONNECT TUBING TO THE INSTRUMENT/BIOPSY CHANNEL (AT THE FORCEPS INLET) ON FUJIFILM GASTROSCOPES AND COLONOSCOPES DURING REPROCESSING WITH THE AER. THE CUSTOMER HAD REALIZED THAT FOR APPROXIMATELY 80 PATIENT PROCEDURES THEY HAD NOT BEEN FOLLOWING THEIR AER OEM (ASP) RECOMMENDATIONS FOR THE AUTOMATED REPROCESSING OF CERTAIN FUJIFILM ENDOSCOPES AND THEY HAD WANTED TO KNOW IF FUJIFILM COULD CONFIRM IF THEIR INSTRUMENTS HAD BEEN ADEQUATELY DISINFECTED (WHILE USING THESE PROCEDURES INCONSISTENT WITH ASP AER RECOMMENDATIONS). THE FACILITY WAS ADVISED THAT SINCE FUJIFILM DOES NOT VALIDATE ASP AERS AND SINCE FUJIFILM DOES NOT HAVE VALIDATION DATA TO SUPPORT THEIR SPECIFIC AER/CHANNEL CONNECTIONS PREVIOUSLY USED THAT THEY SHOULD CONTACT ASP DIRECTLY. THIS EVENT IS A POTENTIAL PATIENT SAFETY CONCERN DUE TO USER ERROR, RESULTING FROM INADEQUATE REPROCESSING OF REUSABLE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522518 FUJINON FUJINON ENDOSCOPES FDA FUJIFILM OPTICS CO., LTD. MITO FACTORY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other RELATED ADAPTERS| ADVANCED STERILIZATION PRODUCTS (ASP)| AUTOMATED ENDOSCOPE REPROCESSOR (AER)