BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS COLONOSCOPE

    MDR report key: 15401589 · Received September 9, 2022

    Report

    Report Number
    MW5111956
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    June 17, 2022
    Report Date
    September 8, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    MNL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON 06/17/2022 INSPECTION OF A COLONOSCOPE IDENTIFIED FOREIGN MATERIAL IN AN OLYMPUS MODEL CF-HQ190L, SERIES COLONOSCOPE. THIS SPURRED SEQUESTRATION OF THE IDENTIFIED SCOPES AND INVESTIGATION OF MODEL 190 SERIES ENDOSCOPES. THIS INVESTIGATION REVEALED AN INTERNAL LOCATION WHERE AVAILABLE BRUSHES WOULD NOT CONTACT THE WALL OF THE DEVICE, RENDERING THE LOCATION UNABLE TO BE CLEANED USING THE MANUFACTURER'S REPROCESSING INSTRUCTIONS. THIS ISSUE WAS IDENTIFIED USING A BORESCOPE WHICH IS USED TO VISUALIZE THE INTERNAL CHANNELS OF ENDOSCOPES TO ENSURE THERE IS NOT DEBRIS OR AREAS THAT NEED REPAIR. IN THIS INSTANCE THE BORESCOPE WAS PASSED THROUGH A DIFFERENT PORT TO SPECIFICALLY LOOK AT THE UNIVERSAL CORD CONNECTOR, FINDING THE DEBRIS. IT WAS DETERMINED THAT THE OLYMPUS BRUSH MODEL CF-HQ190L DOES EFFECTIVELY CLEAN THE IMPACTED AREA. TWO OTHER BRUSHES IN USE AT THAT TIME DID NOT APPROPRIATELY CLEAN THE IMPACTED AREA (B)(4). THE TWO BRUSHES THAT DID NOT EFFECTIVELY CLEAN THE SCOPES ARE: HEDGE HOG BSCI SBD-289-50, BRSH ENDO CLN STERIS CORP 100402. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2545951 OLYMPUS COLONOSCOPE COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID MNL OLYMPUS MEDICAL SYSTEMS CORP. CF-HQ190L
    2607822 HEDGE HOG BSCI ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE MNL BOSTON SCIENTIFIC CORPORATION SBD 289-50
    2607823 BRISH ENDO CLN ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE MNL STERIS CORPORATION 100402

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown BORESCOPE