BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJINON

    MDR report key: 5405959 · Received February 2, 2016

    Report

    Report Number
    2431293-2016-00003
    Event Type
    Malfunction
    Date Received
    February 2, 2016
    Date of Event
    January 5, 2016
    Report Date
    January 5, 2016
    Manufacturer
    FUJIFILM OPTICS CO., LTD. SANO FACTORY
    Product Code
    EOQ
    PMA / PMN Number
    K122535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2016, A FUJIFILM (CS) REPRESENTATIVE ARRIVED ONSITE TO PERFORM A REPROCESSING RE-IN-SERVICE AND TO INVESTIGATE REPORTED DAMAGED BRONCHOSCOPES. STAFF FROM THE CENTRAL STERILE DEPARTMENT DEMONSTRATED ATTACHMENT OF THE FUJIFILM CLEANING ADAPTER (MODEL CA-503B/C) TO THE SUCTION VALVE CYLINDER (INSTEAD OF USING THE APPROPRIATE CLEANING ADAPTER). THIS ADAPTER (CA-503B/C) IS INTENDED FOR CONNECTION TO THE BIOPSY PORT. THE PROCESS SHOWN BY STAFF WAS INCORRECT (COMPARED TO MANUFACTURER'S INSTRUCTIONS) AND IS THE SUSPECTED CAUSE OF THE DAMAGED RUBBER FREEZE SWITCH ON THEIR BRONCHOSCOPES. THE CUSTOMER STATED THEY WERE TOLD TO USE THIS CLEANING ADAPTER DURING AN AER (MEDIVATORS DSD EDGE) IN-SERVICE AFTER THE FACILITY'S REPROCESSING ACTIVITIES WERE MOVED FROM THEIR PULMONARY DEPARTMENT TO THEIR CENTRAL STERILE IN (B)(4) 2015. UPON CONFIRMING THE DAMAGE TO THE BRONCHOSCOPES, IT WAS RECOMMENDED TO NOT USE THEM FOR PROCEDURES. THE HOSPITAL STAFF LOCATED THE PROPER CLEANING ADAPTERS AND AN IN-SERVICE WAS PERFORMED, DEMONSTRATING PROPER USE OF THE CLEANING ADAPTERS CONSISTENT WITH FUJIFILM MANUAL REPROCESSING RECOMMENDATIONS. ON THREE OCCASIONS (1/8/2016, 1/12/2016, 1/13/2016), ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER FOR FURTHER INFORMATION, SUCH AS ANY POSSIBLE PATIENT INJURIES OR SAFETY CONCERNS. AS OF 02/01/2016, NO RESPONSE HAS BEEN RECEIVED. ON 01/14/2016, THE SUBJECT BRONCHOSCOPE WAS RECEIVED AT FUJIFILM MEDICAL SYSTEMS USA- ENDOSCOPY DIVISION. THE DAMAGED RUBBER FREEZE SWITCH WAS CONFIRMED BY SIMULATING ATTACHMENT OF THE FUJIFILM CLEANING ADAPTER IN THE SAME MANNER AS THE CUSTOMER. THE DAMAGED SWITCH WILL BE REPLACED AND THE SUBJECT BRONCHOSCOPE WILL BE RETURNED TO THE CUSTOMER. ON 2/02/2016, THE CUSTOMER WAS INFORMED BY E-MAIL TO CONTACT MEDIVATORS, MANUFACTURER OF THEIR AER TO OBTAIN AND CONFIRM MEDIVATORS LATEST DEVICE-SPECIFIC INSTRUCTIONS FOR REPROCESSING FUJIFILM BRONCHOSCOPES. IT SHOULD BE NOTED THAT A TOTAL OF 5 MDRS (NOS.2431293-2016-00002 THOUGH 2431293-2016-00006) ARE BEING SUBMITTED FOR 5 BRONCHOSCOPES ASSOCIATED WITH THE REPORTED EVENT AT THIS HEALTHCARE FACILITY.

    Description of Event or Problem · 1

    THE CUSTOMER BELIEVED THE FUJIFILM CLEANING ADAPTER (MODEL CA-503 B/C) WAS DAMAGING THE FREEZE BUTTON ON THEIR FUJINON BRONCHOSCOPES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62108 FUJINON VIDEO BRONCHOSCOPE EOQ FUJIFILM OPTICS CO., LTD. SANO FACTORY EB-530H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MEDIVATORS DSD EDGE