BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE REPROCESSOR

    MDR report key: 10373631 · Received August 6, 2020

    Report

    Report Number
    8010047-2020-05339
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 14, 2020
    Report Date
    January 7, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FEB
    UDI-DI
    04953170258589
    PMA / PMN Number
    K103264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION (H10) REGARDING THE REPORTED EVENT. ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE ISSUE HAS BEEN RESOLVED. AFTER THE UNIT COMPLETED THE CYCLE, THE CUSTOMER WAS ABLE TO LOAD A NEW SET INTO THE UNIT WITH NO ERRORS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION (H10) REGARDING THE REPORTED EVENT. ADDITIONAL INFORMATION RECEIVED IDENTIFIED THIS EVENT WAS A RESULT OF USER ERROR.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. BASED ON THE INVESTIGATION RESULTS, THE USER TRIED TO PULL OUT DISINFECTANT BOTTLE DRAWER TO START DISINFECTANT LOADING, BUT WAS UNABLE. WHEN INSTRUCTED TO DRAIN THE DISINFECTANT BEFORE STARTING THE LOADING, THE USER SUCCEEDED. THEREFORE, THE SUGGESTED EVENT WAS DUE TO THE USER HANDLING, NOT DUE TO THE DEVICE DESIGN. THE DEVICE'S OPERATION MANUAL GIVES DIRECTION UNDER SECTION 7.12 "REPLACING THE DISINFECTANT SOLUTION¿. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    CUSTOMER SUPPORT ADVISED THE CUSTOMER TO RESTART THE DRAIN LCG PROCESS AND THE LCG DRAINED WITHOUT ERROR. THE CUSTOMER WAS ALSO INSTRUCTED TO SELECT LOAD LCG ON THE SUBPANEL. THE CUSTOMER WAS ABLE TO OPEN THE DOOR AND LOAD LCG ON THE UNIT. IT IS THOUGHT THAT THE EVENT WAS POSSIBLY A RESULT OF USER ERROR INITIALLY. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER WAS UNABLE TO DRAIN THE DISINFECTANT BOTTLE DRAWER (LCG) ON THE UNIT AND WAS ALSO UNABLE TO A LOAD THE LCG WHEN SELECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840468 ENDOSCOPE REPROCESSOR ENDOSCOPE REPROCESSOR FEB OLYMPUS MEDICAL SYSTEMS CORP. OER-PRO 04953170258589

    Patients

    Seq Age Sex Outcome Treatment
    1