BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA BRONCHOVIDEOSCOPE

    MDR report key: 11907549 · Received May 31, 2021

    Report

    Report Number
    8010047-2021-06914
    Event Type
    Malfunction
    Date Received
    May 31, 2021
    Report Date
    July 13, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K023984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION BUT WAS RETURNED TO OLYMPUS EUROPE (B)(4). OLYMPUS EUROPE (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THE REPORTED PHENOMENON. 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

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. 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. HOWEVER, BASED ON THE REPORTED INFORMATION, IT IS PRESUMED THAT THIS EVENT WAS CAUSED BY SOME PHYSICAL TRESS TO THE INSERTION SECTION. WE CANNOT RULE OUT A POSSIBILITY OF CHEMICAL STRESS DUE TO REPROCESSING, BUT THIS EVENT WAS LIKELY CAUSED BY PHYSICAL STRESS, SUCH AS RUBBING THE INSERTION SECTION WITH SOMETHING HARD. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT IT WAS FOUND THAT THE COATING OF THE INSERTION TUBE HAD BEEN PARTIALLY PEELED OFF DURING THE INCOMING INSPECTION OF THE SUBJECT DEVICE FOR THE REPAIR AT THE SERVICE DEPARTMENT OF OLYMPUS EUROPE (B)(4). THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805993 EVIS EXERA BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-XT160

    Patients

    Seq Age Sex Outcome Treatment
    1