BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA BRONCHOVIDEOSCOPE

    MDR report key: 17078130 · Received June 7, 2023

    Report

    Report Number
    9610595-2023-08508
    Event Type
    Malfunction
    Date Received
    June 7, 2023
    Report Date
    July 28, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    PMA / PMN Number
    K023984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE EVENT WAS UNABLE TO BE IDENTIFIED. THE FAILURE OF THE EQUIPMENT LEADING TO THE EVENT WAS UNABLE TO BE CONFIRMED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "INSPECTION OF THE ENDOSCOPIC IMAGE." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND EVALUATED BUT THE QUALITY INSPECTION RESULTS (QIR) ARE NOT AVAILABLE AS THE DEVICE HAS BEEN DISCONTINUED. THE CUSTOMER¿S ALLEGATION WAS NOT CONFIRMED. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT WHEN USING AN EVIS EXERA BRONCHOVIDEOSCOPE, THERE WAS A NO IMAGE ISSUE. THE DEVICE PASSED THE LEAK TEST, BUT IMAGING WAS NOT WORKING FROM THE SCOPE END. THE EVENT OCCURRED DURING THE DIAGNOSTIC PROCEDURE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587993 EVIS EXERA BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-P160

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown