BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 12479155 · Received September 16, 2021

    Report

    Report Number
    8010047-2021-11794
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    August 23, 2021
    Report Date
    December 22, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305191
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICES HAVE BEEN RETURNED OLYMPUS AUSTRALIA (OAZ). FOR EVALUATION. IN THE EVALUATION OF OAZ THE FOLLOWING WAS CONFIRMED; - BENDING SECTION DAMAGED - AIR/WATER CYLINDER DEFORMED - SUCTION CYLINDER DEFORMED - ENDOSCOPE CONNECTOR DEFORMED OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION BUT WAS RETURNED TO OLYMPUS (B)(4). THE EVALUATION IS IN PROGRESS CURRENTLY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. STAPHYLOCOCCUS AUREUS. OTHER DETAILED INFORMATION SUCH AS THE REPROCESSING METHOD WAS NOT PROVIDED. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378915 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. PCF-H190L 04953170305191

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown