BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE BRONCHOVIDEOSCOPE

    MDR report key: 18151921 · Received November 16, 2023

    Report

    Report Number
    3002808148-2023-12989
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Date of Event
    October 29, 2023
    Report Date
    May 20, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO CORRECT THE MANUFACTURER INFORMATION PREVIOUSLY REPORTED; THE CORRECT MANUFACTURER IS AIZU OLYMPUS CO., LTD. (NOT SHIRAKAWA OLYMPUS CO., LTD.). SEE CHANGES TO D3 AND G1. THE CORRECT FACILITY NUMBER FOR AIZU OLYMPUS CO., LTD. IS (B)(4) (NOT (B)(4)). THIS REPORT IS ALSO 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, ONE OF THE FOLLOWING MECHANISMS OCCURRED CAUSING THE REPORTED EVENT: (1) WHEN PERFORMING HIGH-FREQUENCY CAUTERIZATION, THE USER MAY HAVE LET THE DISTAL END OF THE SUBJECT DEVICE CONTACT WITH MUCOSA, DID NOT PROTRUDE AN ENDO THERAPY ACCESSORY TO THE VISIBLE POSITION OF GREEN MARKING IN SHEATH OF THE ACCESSORY, OR ELECTRIFIED WITHOUT CONTACTING ELECTRODE OF AN ENDO THERAPY ACCESSORY WITH MUCOSA. (2) WHEN PERFORMING LASER CAUTERIZATION, THE USER MAY HAVE PERFORMED TREATMENT WITHOUT KEEPING DISTANCE FROM THE DISTAL END OF THE DEVICE UNTIL THE TIP OF THE LASER PROBE WAS SURELY VISIBLE ON ENDOSCOPIC IMAGE. (3) WHEN PERFORMING ARGON PLASMA COAGULATION (ACP), THE USER MAY NOT HAVE PROTRUDED AN APC PROBE TO THE VISIBLE POSITION OF THE BLACK RING AT TIP OF THE PROBE ON ENDOSCOPIC IMAGE (10 MM OR MORE). A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING WARNINGS FOR HIGH-FREQUENCY CAUTERIZATION: "ALWAYS CONFIRM THAT THE TISSUE IS AN APPROPRIATE DISTANCE AWAY FROM THE DISTAL END OF THE ENDOSCOPE. IF HIGH-FREQUENCY CAUTERIZATION IS PERFORMED WHEN THE DISTAL END OF THE ENDOSCOPE CONTACTS THE TISSUE, PATIENT INJURY, BURNS, BLEEDING, PERFORATION, AND EQUIPMENT DAMAGE MAY OCCUR. TO AVOID PATIENT INJURY, BURNS, BLEEDING, PERFORATION, AND/OR DAMAGE TO THE ENDOSCOPE, NEVER EMIT LASER RADIATION BEFORE CONFIRMING THAT AN APPROPRIATE DISTANCE BETWEEN THE TARGET AND THE ENDOSCOPE¿S DISTAL END IS MAINTAINED AND THE TIP OF THE LASER PROBE IS SURELY IN THE CORRECT POSITION IN THE ENDOSCOPIC IMAGE. THE INSTRUCTIONS FOR USE PROVIDES THE FOLLOWING WARNINGS FOR APC: "MAKE SURE THAT THE DISTAL END OF THE APC PROBE ALWAYS LIES MORE THAN 10 MM FROM THE ENDOSCOPE¿S DISTAL END (SEE FIGURE 4.9). THE PROTRUSION BY 10 MM OR MORE CAN BE IDENTIFIED WHEN THE FIRST BLACK RING ON THE APC PROBE¿S DISTAL END IS VISIBLE IN THE ENDOSCOPIC IMAGE. OTHERWISE, THE TREATED REGION CANNOT BE IRRADIATED CORRECTLY AND THE ENDOSCOPE MAY BE DAMAGED. USING A DAMAGED ENDOSCOPE MAY CAUSE PATIENT INJURY." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER¿S ALLEGATION WAS CONFIRMED. HOWEVER, THE REPORTABLE MALFUNCTION NOTED IN THE EVENT DESCRIPTION WAS OBSERVED. IN ADDITION, INSPECTION NOTED A PIN HOLE IN THE BENDING SECTION COVER RUBBER AND THE DISTAL END INSERTION SECTION WAS DAMAGED AND DEFORMED. THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIVING ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE EVIS LUCERA ELITE BRONCHOVIDEOSCOPE¿S BENDING COVER WAS LEAKING. IT WAS UNKNOWN WHEN THE ISSUE WAS FOUND. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, IT WAS OBSERVED THAT THE DISTAL END COVER WAS BURT. THERE WERE NO REPORTS OF PATIENT HARM, NO DELAYS AND THE PATIENT WAS NOT UNDER ANESTHESIA. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION FOUND DURING DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600824 EVIS LUCERA ELITE BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-1TQ290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown