BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSTOM ULTRASONICS

    MDR report key: 1315771 · Received February 19, 2009

    Report

    Report Number
    2523209-2009-00005
    Event Type
    Other
    Date Received
    February 19, 2009
    Date of Event
    January 21, 2009
    Report Date
    February 10, 2009
    Manufacturer
    CUSTOM ULTRASONICS INC
    Product Code
    NVE
    PMA / PMN Number
    K983017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT THAT A PT WAS EXPOSED TO AN INADEQUATELY DISINFECTED COLONOSCOPE AS A DIRECT RESULT OF IMPROPER CALIBRATION OF DISINFECTANT AND IMMERSION TIME BY SERVICE TECH AT INITIAL INSTALLATION. SVC TECH DISPATCHED IMMEDIATELY TO ADJUST CALIBRATION TO CORRECT DISINFECTANT PARAMETERS. ROOT CAUSE IS TECH ERROR. ALTHOUGH UNLIKELY, THIS CONDITION CAN PUT THE PT AT RISK FOR INFECTION. ONE PT DURING ONE PROCEDURE WAS PUT AT RISK ACCORDING TO THE FACILITY CONTACT. (B) (6) FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ULTRASONICS AUTOMATIC ENDOSCOPE REPROCESSOR NVE CUSTOM ULTRASONICS INC SYSTEM 83+9 EQ3467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other