BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 18848106 · Received March 6, 2024

    Report

    Report Number
    9610595-2024-04744
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    February 21, 2024
    Report Date
    April 10, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170335181
    PMA / PMN Number
    K121959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND THE EVALUATION FOUND THE REPORTED ISSUE WAS REPRODUCED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. 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, IT IS LIKELY THE USER USED A HIGH ENERGY ENDO THERAPY ACCESSORY, SUCH AS LASER AND HIGH FREQUENCY, WITHOUT KEEPING ENOUGH DISTANCE FROM THE DISTAL END OF THE SUBJECT DEVICE. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. USER CAN DETECT THE SUGGESTED EVENT BY HANDLING DEVICE IN ACCORDANCE WITH THE FOLLOWING INSTRUCTIONS FOR USE (IFU). OPERATION MANUAL_ PREPARATION AND INSPECTION_ INSPECTION OF THE ENDOSCOPE "INSPECT THE EXTERNAL SURFACE OF THE ENTIRE INSERTION SECTION, INCLUDING THE BENDING SECTION AND THE DISTAL END FOR DENTS, BULGES, SWELLING, SCRATCHES, PEELING OF COATING, HOLES, SAGGING, TRANSFORMATION, BENDS, ADHESION OF FOREIGN BODIES, MISSING PARTS, PROTRUDING OBJECTS, OR OTHER IRREGULARITIES". USER MAY PREVENT THE SUGGESTED EVENT BY HANDLING DEVICE IN ACCORDANCE WITH THE FOLLOWING INSTRUCTIONS FOR USE (IFU). OPERATION MANUAL: USING ENDOTHERAPY ACCESSORIES *HIGH-FREQUENCY CAUTERIZATION TREATMENT "ALWAYS CONFIRM THAT THE ELECTRODE SECTION OF THE ELECTROSURGICAL ACCESSORY IS AT AN APPROPRIATE DISTANCE FROM THE DISTAL END OF THE ENDOSCOPE. CONFIRM THAT THE ENTIRE GREEN MARKING (IN CASE OF WLI OBSERVATION MODE) AT THE DISTAL TIP OF THE ELECTROSURGICAL ACCESSORY CAN BE OBSERVED ON THE ENDOSCOPIC IMAGE. IF THE ELECTRODE IS USED WHEN IT IS TOO CLOSE TO THE DISTAL END OF THE ENDOSCOPE, THE ENDOSCOPE AND/OR ANCILLARY EQUIPMENT MAY BE DAMAGED. PATIENT INJURY, BURNS, BLEEDING, PERFORATION, AND/OR EQUIPMENT DAMAGE MAY RESULT". LASER CAUTERIZATION WARNING: "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". OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE BRONCHOVIDEOSCOPE TIP WAS BURNT BY A TOOL. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534439 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-1TH190 04953170335181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown