BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSTOM ULTRASONICS

    MDR report key: 1289478 · Received January 13, 2009

    Report

    Report Number
    2523209-2009-00001
    Event Type
    Other
    Date Received
    January 13, 2009
    Date of Event
    December 15, 2008
    Report Date
    January 12, 2009
    Manufacturer
    CUSTOM ULTRASONICS, INC.
    Product Code
    FLG
    PMA / PMN Number
    K983017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OUR SERVICE TECHNICIAN WAS DISPATCHED TO THE FACILITY UPON LEARNING OF THE INCIDENT. TESTING AND INSPECTION OF THE 3 SYSTEM 83 REPROCESSORS REVEALED RANDOM AND ROUTINE STORAGE OF IRRIGATION BOTTLES AND DISINFECTANT BOWLS INSIDE THE DISINFECTANT RESERVOIR OF ALL 3 FACILITY OWNED CUSTOM ULTRASONICS DEVICES. WE HAVE CONCLUDED THE RESIDUAL DISINFECTANT WAS ABLE TO ENTER IRRIGATION BOTTLE AND LINES. UNLESS PROPERLY PROCESSED, RESIDUAL DISINFECTANT WILL REMAIN IN THE IRRIGATION BOTTLE LINES. FACILITY PERSONNEL COULD NOT PRODUCE ANY SOP FOR PROPER PROCESSING OF THE BOTTLES AND LINES. THESE ARE ACCESSORIES SUPPLIED BY ANOTHER MANUFACTURER AND NOT SUPPLIED BY CU. IT IS THEREFORE, ALSO LIKELY THAT DISINFECTANT SOLUTION WAS INTRODUCED INTO AT LEAST 4 PATIENTS AT THE TIME OF COLONOSCOPY VIA THE IRRIGATION BOTTLE AND OR ITS TUBING. DISINFECTION SOLUTION CAN CAUSE DAMAGE WHEN EXPOSED TO TISSUE. IN THE EVENT OF CONTACT WITH THE COLON, COLITIS CAN OCCUR. SERVICE TECHNICIAN COMPLETED THE EVALUATION AND TESTING OF ALL SYSTEM 83+9'S AT THIS FACILITY. STAFF WAS RETRAINED FOR PROPER USE OF THE REPROCESSOR AND WERE DIRECTED TO THE USER MANUAL REQUIREMENTS WHICH CAUTION AGAINST STORING ANYTHING IN THE DISINFECTANT RESERVOIR OF THE SYSTEM 83+9 OR INJURY TO PATIENTS COULD OCCUR. INFECTION CONTROL MANAGEMENT WERE URGED TO PROVIDE ON-SITE SURVEILLANCE OF CONTAINER STORAGE PRACTICES SO THAT NO RESIDUAL DISINFECTANT INJURY WOULD OCCUR. DISINFECTANT NOT SUPPLIED OR MARKETED BY CUSTOM ULTRASONICS, INC. THE 3 SYSTEM 83+9'S WERE FOUND TO BE IN PERFECT WORKING ORDER. WE DID RECOMMEND A ROUTINE PREVENTATIVE MAINTENANCE AND REPLACEMENT OF SCOPE ADAPTERS WHICH WERE FOUND TO BE OLD.

    Description of Event or Problem · 1

    POSSIBLE COLITIS CONDITION REPORTED FOR 4 PATIENTS RECEIVING COLONOSCOPIES IN 2008, FOLLOWING COLONOSCOPE REPROCESSING USING CUSTOM ULTRASONICS SYSTEM 83+9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ULTRASONICS SYSTEM 83+9 WASHER /DISINFECTOR FLG CUSTOM ULTRASONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other & FLUSH BOWLS ROUTINELY USED.| COLONOSCOPE ACCESSORY IRRIGATION SUPPLY BOTTLES