BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSTOM ULTRASONICS

    MDR report key: 1916569 · Received December 6, 2010

    Report

    Report Number
    2523209-2010-00003
    Event Type
    Other
    Date Received
    December 6, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 18, 2010
    Manufacturer
    CUSTOM ULTRASONICS, INC.
    Product Code
    FLG
    PMA / PMN Number
    983017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR SERVICE TECHNICIAN WAS DISPATCHED TO THE USER FACILITY. IT WAS OBSERVED THAT THE FACILITY WAS ATTEMPTING TO WASH/DISINFECT THE OLYMPUS (B)(4) IRRIGATION TUBING ALONG WITH OLYMPUS FILTERS. ALL ARE NOT RECOMMENDED FOR WASHING/DISINFECTION IN THE SYSTEM 83. RE-INSERVICE TRAINING WAS CONDUCTED.

    Description of Event or Problem · 1

    POSSIBILITY FOR PT COLITIS DUE TO IMPROPER REPROCESSING PROCEDURES. THIS MAY HAVE RESULTED IN RESIDUAL DISINFECTANT IN THIS FACILITY'S FLEXIBLE ENDOSCOPES AND THE (B)(4) IRRIGATION ACCESSORY TO POSSIBLY TRANSFER TO PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ULTRASONICS SYSTEM 83 PLUS FLG CUSTOM ULTRASONICS, INC. SYSTEM 83+9 EQ#3285

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other