BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 10668614 · Received October 13, 2020

    Report

    Report Number
    8010047-2020-07600
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Date of Event
    September 14, 2020
    Report Date
    December 10, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305115
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE SUBJECT DEVICE EVALUATION RESULT. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS AUSTRALIA (OAZ). OAZ SERVICE DEPARTMENT CHECKED THE SUBJECT DEVICE AND FOUND THE FOLLOWINGS. THE RANGE OF THE ANGULATION WAS INSUFFICIENT FOR SPECIFICATION. THE RUBBER GLUE WERE DETACHED, CHIPPED, CRACKED, AND BURRED. THE SWITCH 1 COVER WAS CUT. OAZ REQUESTED THE FACILITY TO PROVIDE THE INFORMATION REGARDING REPROCESSING, HOWEVER THE FACILITY DID NOT PROVIDE AND OAZ COULD NOT OBTAIN IT. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE DEVICE FAILED A MICROBIOLOGICAL TEST TWICE AT THE USER FACILITY. THE SAMPLE COLLECTED FROM THE DEVICE TESTED POSITIVE FOR KLEBSIELLA PNEUMONIAE. 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
    1137694 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-HQ190L 04953170305115

    Patients

    Seq Age Sex Outcome Treatment
    1