BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 17476009 · Received August 7, 2023

    Report

    Report Number
    9610595-2023-11271
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    March 17, 2023
    Report Date
    August 7, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170434983
    PMA / PMN Number
    K201758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY¿S MDR AND COMPLAINT HANDLING PROCESSES. CAPAS HAVE BEEN OPENED TO MANAGE THE ACTIONS THAT ARE BEING TAKEN TO REMEDIATE THIS ISSUE AND ENSURE ANY REQUIRED MDR REPORTING IS COMPLETED. IN ADDITION TO B5, THE FOLLOWING NON-REPORTABLE MALFUNCTIONS WERE FOUND DURING THE DEVICE EVALUATION: THE BENDING SECTION ADHESIVE HAD A HOLE CAUSING A LEAK, AND THE SCOPE CONNECTED WAS LOOSE. 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 VENTING CONNECTOR OF THE SCOPE CONNECTOR WAS LOOSENED BY IMPROPER HANDLING OF ENDO THERAPY ACCESSORIES BY THE USER. THAT CAUSED FLUID INVASION ON THE SCOPE CONNECTOR, AS A RESULT NO IMAGE APPEARED. USERS MAY BE ABLE TO DETECT THE SUGGESTED EVENT BY HANDLING DEVICE IN ACCORDANCE WITH THE FOLLOWING INSTRUCTIONS FOR USE (IFU): - "PERFORM A LEAKAGE TEST ON THE ENDOSCOPE AFTER EACH PRECLEANING PROCEDURE. DO NOT USE THE ENDOSCOPE IF A LEAK IS DETECTED. USE OF AN ENDOSCOPE WITH A LEAK MAY CAUSE A SUDDEN LOSS OF THE ENDOSCOPIC IMAGE, DAMAGE TO THE BENDING MECHANISM, OR OTHER MALFUNCTIONS. USE OF A LEAKING ENDOSCOPE MAY ALSO POSE AN INFECTION CONTROL RISK." USERS MAY BE ABLE TO REDUCE / PREVENT OCCURRENCE OF THE SUGGESTED EVENT BY HANDLING DEVICE IN ACCORDANCE WITH THE FOLLOWING IFU: - "WHEN INSERTING OR WITHDRAWING AN ENDO THERAPY ACCESSORY, CONFIRM THAT ITS DISTAL END IS CLOSED OR COMPLETELY RETRACTED INTO THE SHEATH. SLOWLY INSERT OR WITHDRAW THE ENDO THERAPY ACCESSORY STRAIGHT INTO OR FROM THE SLIT OF THE BIOPSY VALVE. OTHERWISE, THE BIOPSY VALVE OR INSTRUMENT CHANNEL MAY BE DAMAGED AND PIECES OF IT COULD FALL OFF. IT MAY CAUSE PATIENT INJURY. - IF INSERTION OR WITHDRAWAL OF ENDO THERAPY ACCESSORIES IS DIFFICULT, STRAIGHTEN THE BENDING SECTION AS MUCH AS POSSIBLE WITHOUT LOSING THE ENDOSCOPIC IMAGE. INSERTING OR WITHDRAWING ENDO THERAPY ACCESSORIES WITH EXCESSIVE FORCE MAY DAMAGE THE INSTRUMENT CHANNEL OR ENDO THERAPY ACCESSORIES AND COULD CAUSE SOME PARTS TO FALL OFF AND/OR CAUSE PATIENT INJURY. - IF THE DISTAL END OF AN ENDO THERAPY ACCESSORY IS NOT VISIBLE IN THE ENDOSCOPIC IMAGE, DO NOT OPEN THE DISTAL END OR EXTEND THE NEEDLE OF THE ENDO THERAPY ACCESSORY. THIS COULD CAUSE PATIENT INJURY, BLEEDING, PERFORATION, AND/OR EQUIPMENT DAMAGE." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    A USER FACILITY RETURNED AN OLYMPUS ASSET TO THE SERVICE CENTER. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, NO IMAGE WAS OBSERVED AFTER AERATION. THIS REPORT IS BEING SUBMITTED FOR THE EVENT FOUND DURING EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699394 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-P190 04953170434983

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown