BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERAIII BRONCHOVIDEOSCOPE

    MDR report key: 8627006 · Received May 21, 2019

    Report

    Report Number
    8010047-2019-01984
    Event Type
    Malfunction
    Date Received
    May 21, 2019
    Date of Event
    April 12, 2019
    Report Date
    July 10, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K121959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION RESULT. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS AUSTRALIA.(OAZ) FOR EVALUATION. IN THE EVALUATION, OAZ CONFIRMED A PART OF THE LIGHT GUIDE OF THE SUBJECT DEVICE WAS LOOSE. 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.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS (B)(4) FOR EVALUATION. IN THE EVALUATION, (B)(4) CONFIRMED THE LEAKAGE FROM THE INSTRUMENT CHANNEL OF THE SUBJECT DEVICE. 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 AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF ROUTINE MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SUBJECT DEVICE TESTED POSITIVE FOR UNSPECIFIED MICROBES. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION SUCH AS THE NUMBER AND THE TYPE OF MICROBES. THE DEVICE HAD BEEN MANUALLY REPROCESSED. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423669 EVIS EXERAIII BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1TH190

    Patients

    Seq Age Sex Outcome Treatment
    1