BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE REPROCESSOR

    MDR report key: 14423870 · Received May 17, 2022

    Report

    Report Number
    8010047-2022-08362
    Event Type
    Malfunction
    Date Received
    May 17, 2022
    Date of Event
    April 19, 2022
    Report Date
    July 8, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FEB
    UDI-DI
    04953170258589
    PMA / PMN Number
    K103264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FSE INDICATED THE CUSTOMER WAS STILL USING THE UNIT BECAUSE THEY WERE GOING BY THE TEST STRIP RESULTS AND NOT BY THE LCG LIGHT BLINKING. THE CUSTOMER WAS INFORMED OF THE EXPIRED LCG TO REPLACE, TO CHANGE THE LCG ON THE FIFTH DAY OR WHEN THE LCG LIGHT IS BLINKING. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDICAL DEVICE REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 6 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE OCCURRENCE WAS CAUSED BY THE FOLLOWING: THE USER DID NOT UNDERSTOOD THE MAXIMUM EXPIRATION DATE. THE USER DID NOT CONFIRM INSTRUCTIONS FOR USE (IFU) CONTENT. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. THE EVENT CAN BE DETECTED/PREVENTED BY READING THE FOLLOWING: 4. INFLUENCE OF MISUSE AND LABELING REVIEW INCLUDING IFU - WE CONFIRMED THAT IFU SAYS ABOUT THE SUGGESTED EVENT AND CALLS THE USER¿S ATTENTION. ¿6.4 SETTING THE DISINFECTANT SOLUTION COUNTER ·NOTE ON THE DISINFECTANT SOLUTION COUNTER FUNCTION¿ ACCORDING TO ACECIDE-C HOME PAGE, ¿REUSE PERIOD: UP TO 5 DAYS¿. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. MANUFACTURER DATE CORRECTED TO DEC 15, 2015.

    Description of Event or Problem · 0

    THE OLYMPUS FIELD SERVICE ENGINEER (FSE) BECAME AWARE THAT DURING A PREVENTATIVE MAINTENANCE ON THE CUSTOMER¿S ENDOSCOPE REPROCESSOR MACHINE, THE CUSTOMER REPORTED THE LIQUID CHEMICAL GERMICIDE (LCG) HAS BEEN IN OVERUSE FOR 4 DAYS AND NOT REPLACED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE. THE UNIT IS NOW ON DAY 9 FOR LCG USAGE. THE LCG LIGHT WAS BLINKING WHEN THE FSE ARRIVED ONSITE. NO DEATH, INJURY OR HARM WAS REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2345506 ENDOSCOPE REPROCESSOR ENDOSCOPE REPROCESSOR FEB OLYMPUS MEDICAL SYSTEMS CORP. OER-PRO 04953170258589

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown