BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAF-GM (E)

    MDR report key: 6126959 · Received November 24, 2016

    Report

    Report Number
    8010047-2016-10070
    Event Type
    Malfunction
    Date Received
    November 24, 2016
    Date of Event
    October 15, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    PK082720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS TO PROVIDE THE DEVICE EVALUATION RESULTS. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS (B)(4) FOR FURTHER EVALUATION. AS A RESULT OF THE CULTURE TEST ON THE SUBJECT DEVICE WHICH (B)(4) ORDERED AN INDEPENDENT LABORATORY, NO MICROORGANISM WAS DETECTED. AS A RESULT OF DEVICE EVALUATION AT (B)(4), THE LEAKAGE FROM THE SWITCH BUTTON OF THE SUBJECT DEVICE WAS CONFIRMED. SIGNS OF WEAR AND TEAR WERE FOUND ON THE BENDING SECTION OF THE SUBJECT DEVICE. AS STATED ABOVE, THE EXACT CAUSE OF THE REPORTED EVENT HAS NOT BEEN DETERMINED. HOWEVER, THE POSSIBILITY CANNOT BE RULED OUT THAT IT WAS CAUSED BY INSUFFICIENT MAINTENANCE AT THE USER FACILITY SUCH AS CONTINUOUS USE OF THE SUBJECT DEVICE IN SPITE OF THE LEAKAGE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORD OF THE DEVICE WAS REVIEWED WITHOUT IRREGULARITY. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS REPAIR CENTER IN (B)(4). THE OLYMPUS REPAIR CENTER HAS SEGREGATED THE SCOPE UNTIL THE FINAL RESULTS OF THE CULTURE TEST WILL BE FOUND. THE EXACT CAUSE COULD NOT BE DETERMINED AT PRESENT. OMSC IS FOLLOWING UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL FOLLOW. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT ENTEROBACTERIACEAE WAS DETECTED FROM THE INSTRUMENT CHANNEL OF THE SUBJECT DEVICE DURING A CULTURE TEST. STAPHYLOCOCCUS EPIDERMIDIS AND ENTEROBACTERIACEAE WERE DETECTED FROM THE DETERGENT SOLUTION WHICH WAS USED FOR THE SUBJECT DEVICE. RHIZOBIUM RADIOBACTER WAS DETECTED FROM THE RINSE WATER OF MINI ETD (OLYMPUS AUTOMATED ENDOSCOPE PREPROCESSOR). THERE WAS NO INFECTION REPORT ASSOCIATED WITH THIS REPORT. THE FACILITY HAS CONTINUED THE CULTURE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777821 MAF-GM (E) AIRWAY MOBILESCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. MAF-GM

    Patients

    Seq Age Sex Outcome Treatment
    1