BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE PLUS

    MDR report key: 8547022 · Received April 24, 2019

    Report

    Report Number
    2150060-2019-00033
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    March 26, 2019
    Report Date
    April 24, 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

    DURING A SERVICE VISIT FOR AN ADVANTAGE PLUS AUTOMATED ENDOSCOPE RE-PROCESSOR (AER), A MEDIVATORS FIELD SERVICE ENGINEER (FSE) REPORTED THE RIGHT BASIN SPRAY HEAD OF THE AER WAS NOT SPINNING DURING A REPROCESSING CYCLE. THERE IS POTENTIAL THAT ENDOSCOPES REPROCESSED IN THE RIGHT BASIN OF THE AER WERE NOT ADEQUATELY HIGH-LEVEL DISINFECTED AND, THEREFORE, POTENTIAL FOR PATIENT CROSS-CONTAMINATION. MEDIVATORS FSE REPLACED THE RIGHT BASIN SPRAY HEAD AND RETURNED THE UNIT TO SERVICE. THE AER USER MANUAL INSTRUCTS USERS TO VERIFY THAT THE SPRAY HEAD IS SPINNING DURING EACH REPROCESSING CYCLE. IF NOT, THE EXTERIOR PARTS OF ENDOSCOPES THAT ARE NOT FULLY SUBMERGED IN THE BASIN DURING REPROCESSING ARE POTENTIALLY NOT ADEQUATELY HIGH-LEVEL DISINFECTED. THE INTERNAL CHANNELS OF THE ENDOSCOPE ARE NOT AFFECTED AND WOULD HAVE BEEN PROPERLY HIGH-LEVEL DISINFECTED. THE PORTION OF THE ENDOSCOPE IN DIRECT CONTACT WITH THE PATIENT IS PLACED TOWARD THE BOTTOM OF THE AER BASIN DURING REPROCESSING AND WOULD BE FULLY SUBMERGED DURING THE CYCLE AND, THEREFORE, RECEIVE ADEQUATE HIGH-LEVEL DISINFECTION. AT THIS TIME, THE TYPES AND NUMBER OF ENDOSCOPES REPROCESSED WHILE THE RIGHT BASIN SPRAY HEAD WAS NOT SPINNING IS UNKNOWN. 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

    DURING A SERVICE VISIT FOR AN ADVANTAGE PLUS AUTOMATED ENDOSCOPE RE-PROCESSOR (AER), A MEDIVATORS FIELD SERVICE ENGINEER (FSE) REPORTED THE RIGHT BASIN SPRAY HEAD OF THE AER WAS NOT SPINNING DURING A REPROCESSING CYCLE. THERE IS POTENTIAL THAT ENDOSCOPES REPROCESSED IN THE RIGHT BASIN OF THE AER WERE NOT ADEQUATELY HIGH-LEVEL DISINFECTED AND, THEREFORE, POTENTIAL FOR PATIENT CROSS-CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337308 ADVANTAGE PLUS AUTOMATED ENDOSCOPE REPROCESSOR FEB MEDIVATORS INC. 00677964044755

    Patients

    Seq Age Sex Outcome Treatment
    1 Other