BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AW-500-G VERSION C

    MDR report key: 6727866 · Received July 12, 2017

    Report

    Report Number
    6727866
    Event Type
    Injury
    Date Received
    July 12, 2017
    Date of Event
    June 13, 2017
    Report Date
    July 11, 2017
    Manufacturer
    FUJI FILM MEDICAL SYSTEMS
    Product Code
    FFY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN SCOPE WAS REMOVED FROM PATIENT AT THE END OF THE PROCEDURE AND PHYSICIAN WENT TO SUCTION ENZYMATIC CLEANER THROUGH THE SCOPE HE NOTICED THAT THE SCOPE WAS CONTINUOUSLY BLOWING AIR BY ITSELF. PATIENT UNDERWENT COLONOSCOPY ON (B)(6)2017. UPON COMPLETION OF PROCEDURE WHEN PHYSICIAN WENT TO SUCTION ENZYMATIC SOLUTION THROUGH THE SCOPE HE NOTICED THAT THERE WAS CONTINUOUS AIR FLOW GOING THROUGH THE SCOPE EVEN THOUGH HE WAS NOT PRESSING THE AIR/WATER BUTTON. ENDOSCOPE AND BUTTONS WERE CLEANED AND PROCESSED BY MEANS OF HIGH LEVEL DISINFECTION AND WHEN TESTED FOR USE FOR ANOTHER PROCEDURE IT WAS NOTICED THAT THE SCOPE STILL HAD A CONTINUOUS AIR FLOW EVEN THOUGH THE AIR/WATER BUTTON WAS NOT BEING PRESSED. THE BUTTONS WERE CHANGED WITH DIFFERENT BUTTONS BUT THE PROBLEM CONTINUED AND THE SCOPE WAS TAKEN OUT OF SERVICE. PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6)2017 VIA THE EMERGENCY DEPARTMENT AND UNDERWENT SURGERY FOR COLONIC PERFORATION. PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6)2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488943 AW-500-G VERSION C AIR WATER BUTTON (VALVE) FFY FUJI FILM MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| O| R