BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSTOM ULTRASONICS

    MDR report key: 2214010 · Received August 1, 2011

    Report

    Report Number
    2523209-2011-00004
    Event Type
    Other
    Date Received
    August 1, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 28, 2011
    Manufacturer
    CUSTOM ULTRASONICS, INC.
    Product Code
    FLG
    PMA / PMN Number
    983017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4) REC'D A TELEPHONE CALL FROM (B)(6), FROM (B)(6). SHE INDICATED THAT THE HOSPITAL RAN TWO "WASH ONLY" CYCLES ON TWO SEPARATE COLONOSCOPES USED ON TWO PTS, W/O THE SCOPES BEING HIGH-LEVEL DISINFECTED. THE HOSPITAL INDICATED THAT THE TWO SCOPES IN QUESTION WERE PRE-CLEANED IN THE PROCEDURE ROOM, FOLLOWED WITH MANUAL CLEANING, LEAK TESTING, PLUNGED WITH DETERGENT AND H2O, VIA SCOPE BUDDY, WASHED IN THE SYSTEM 83 AND FLUSHED WITH ALCOHOL. HOWEVER, THE SCOPES WERE NOT EXPOSED TO A HIGH-LEVEL DISINFECTANT THERE IS A POTENTIAL "LOW" RISK OF EXPOSURE TO VEGETATIVE BACTERIA AND FUNGI AND A BREACH WITHIN THE SYSTEM 83 SPECIFICATIONS AND PROCEDURES. CUSTOM HAS PROVIDED A RISK ASSESSMENT AND SCREEN SHOT OF THE "WASH-ONLY" WARNING AND IS INCLUDED WITH THIS FILING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ULTRASONICS SYSTEM 83 PLUS FLG CUSTOM ULTRASONICS, INC. 83+9 EQ 2335

    Patients

    Seq Age Sex Outcome Treatment
    1 Other