BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSTEM 83 PLUS 2

    MDR report key: 3205234 · Received June 28, 2013

    Report

    Report Number
    2523209-2013-00009
    Event Type
    Other
    Date Received
    June 28, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    CUSTOM ULTRASONICS INC
    Product Code
    FEB
    PMA / PMN Number
    K122172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUPERVISOR IMMEDIATELY STOPPED THE PROCESS AND RE PROCESSED THE SCOPES THAT WERE CURRENTLY BEING PROCESSED. HOWEVER, THERE WERE 12 SCOPES THAT WERE USED ON PTS THAT WERE NOT PROPERLY DISINFECTED. THERE WERE NO PT INJURIES REPORTED AT THE TIME OF THIS REPORT. THERE MAY BE AN INCREASED RISK OF INFECTION ASSOCIATED WITH THIS INCIDENT. THE FACILITY REP STATED THAT THEY WILL NOTIFY THEIR PTS OF THIS INCIDENT. CUSTOM ULTRASONICS INC IS REPORTING THIS INCIDENT WITH AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    REPORTED EVENT: INEFFECTIVE REPROCESSING OF ENDOSCOPES. TWELVE (12) GI ENDOSCOPES WERE NOT PROPERLY PROCESSED THROUGH THE DISINFECT CYCLE. THE CAUSE OF THIS EVENT WAS DUE TO USER ERROR. THE USER (IN TRAINING) PROCESSED ENDOSCOPES USING A "WASH ONLY" CYCLE. OUR INVESTIGATION DETERMINED THAT THE USER WAS COMPLETING COMPETENCY TRAINING AT THE TIME OF THIS EVENT. THE SUPERVISOR OVERSEEING THE TRAINING REVIEWED AND ENSURED THE CORRECT SET UP PARAMETERS FOR PROCESSING OF ENDOSCOPES USING SYSTEM 83 PLUS. THE SUPERVISOR LEFT THE ROOM FOR A PERIOD OF TIME. UPON HER RETURN, THE SUPERVISOR VERIFIED PROCESS PARAMETERS FROM THE SYSTEM 83 PLUS PRINT OUT AND NOTICED THAT THE SCOPES WERE NOT PROCESSED THROUGH THE DISINFECT CYCLES, AS IT WOULD HAVE IF THE PROPER CYCLES HAD BEEN SELECTED INITIALLY. THE FACILITY REP INDICATED THAT THESE SCOPES WERE PRE-PROCESSED ACCORDING TO (B)(4). ALL SCOPE ADAPTERS WERE PROPERLY CONNECTED TO FACILITATE FLOW THROUGH THE SCOPES AS THEY WERE PROCESSED THROUGH THE WASH CYCLE. OUR RECORDS INDICATE THAT THERE WAS NO PREVIOUS HISTORY OF USER ERROR FOUND WITH THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295107 SYSTEM 83 PLUS 2 WASHER-DISINFECTOR FEB CUSTOM ULTRASONICS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other