BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSTOM ULTRASONICS

    MDR report key: 2537872 · Received January 15, 2009

    Report

    Report Number
    2523209-2009-00002
    Event Type
    Other
    Date Received
    January 15, 2009
    Date of Event
    January 7, 2009
    Report Date
    January 14, 2009
    Manufacturer
    CUSTOM ULTRASONICS, INC.
    Product Code
    FLG
    PMA / PMN Number
    K983017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL USER REQUEST FOR RECALIBRATION REQUIRED FOR CHANGE OF DISINFECTANT TYPE. CU SOFTWARE CALIBRATION FOR DISINFECTANT PARAMETER CHANGE NOT ACCESSIBLE BY END USER AND MUST BE PERFORMED BY CUSTOM ULTRASONICS. ROOT CAUSE WAS EMPLOYEE SOP ERROR WITH EFFECTING WRONG CALIBRATION OF DISK. THIS CONDITION AFFECTED ONLY ONE OF TWO SYSTEM BAYS. CORRECTLY CALIBRATED DISK WAS SENT AS REPLACEMENT AND THE SYSTEM IS WORKING PERFECTLY AS PER INTERVIEW WITH DR. (B)(6). PTS HAVE BEEN NOTIFIED OF THE POTENTIAL FOR INFECTION RISK AND FOLLOW-UP PT TESTING IS SCHEDULED AS NEEDED BY THE FACILITY PERSONNEL. ON-SITE SERVICE VISIT IS SCHEDULED FOR WEEK OF (B)(4) 2009 TO CONFIRM OVERALL FUNCTION OF BOTH SYSTEMS AT THIS FACILITY.

    Description of Event or Problem · 1

    SIX PTS WERE ENDOSCOPED OVER A 2 DAY PERIOD USING ENDOSCOPES DISINFECTED WITH RAPICIDE FOR 12 MIN SOAK AT 27-28 DEGREES CELSIUS. RAPICIDE LABELING CALLS FOR 5 MIN SOAK AT 35 DEGREES CELSIUS. WHILE UNLIKELY, THIS CONDITION MAY CREATE THE POTENTIAL FOR RISK OF INFECTION TO THESE PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ULTRASONICS SYSTEM 83+9 REPROCESSOR FLG CUSTOM ULTRASONICS, INC. SYSTEM 83+9 EQ 1767

    Patients

    Seq Age Sex Outcome Treatment
    1 Other