BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE PLUS

    MDR report key: 8684983 · Received June 10, 2019

    Report

    Report Number
    2150060-2019-00048
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    May 20, 2019
    Report Date
    June 10, 2019
    Manufacturer
    MEDIVATORS INC.
    Product Code
    FEB
    UDI-DI
    00677964044755
    PMA / PMN Number
    K102996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MEDIVATORS SALES REPRESENTATIVE REPORTED A FACILITY USING PROLYSTICA ENZYMATIC INSTRUMENT DETERGENT IN THEIR ADVANTAGE PLUS AUTOMATED ENDOSCOPE REPROCESSOR (AER). PROLYSTICA DETERGENT IS NOT VALIDATED FOR USE WITH THE ADVANTAGE PLUS AER. PER THE AER IFU, ONLY INTERCEPT DETERGENT IS VALIDATED FOR USE IN THE CLEANING CYCLE OF THE AER, THEREFORE THERE IS POTENTIAL THAT THE ENDOSCOPES CLEANED WITH PROLYSTICA DETERGENT WERE NOT ADEQUATELY REPROCESSED. IT IS UNKNOWN HOW LONG THE FACILITY HAS BEEN USING PROLYSTICA WITH THEIR ADVANTAGE PLUS AER. IT WAS REPORTED THAT THE FACILITY OTHERWISE FOLLOWS APPROPRIATE REPROCESSING PROCESSES. MEDIVATORS FIELD SERVICE REPRESENTATIVE INSTRUCTED THE FACILITY TO DISCONTINUE USE OF PROLYSTICA DETERGENT WITH THE ADVANTAGE PLUS AER. THERE HAVE BEEN NO REPORTS OF PATIENT HARM. THIS COMPLAINT WILL CONTINUE TO BE MONITORED IN THE MEDIVATORS COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    MEDIVATORS SALES REPRESENTATIVE REPORTED A FACILITY USING PROLYSTICA ENZYMATIC INSTRUMENT DETERGENT IN THEIR ADVANTAGE PLUS AUTOMATED ENDOSCOPE REPROCESSOR (AER). PROLYSTICA DETERGENT IS NOT VALIDATED FOR USE WITH THE ADVANTAGE PLUS AER. PER THE AER IFU, ONLY INTERCEPT DETERGENT IS VALIDATED FOR USE IN THE CLEANING CYCLE OF THE AER, THEREFORE THERE IS POTENTIAL THAT THE ENDOSCOPES CLEANED WITH PROLYSTICA DETERGENT WERE NOT ADEQUATELY REPROCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479028 ADVANTAGE PLUS AUTOMATED ENDOSCOPE REPROCESSOR FEB MEDIVATORS INC. 00677964044755

    Patients

    Seq Age Sex Outcome Treatment
    1 Other