BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE

    MDR report key: 22720784 · Received August 5, 2025

    Report

    Report Number
    9615393-2025-00087
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 17, 2025
    Report Date
    August 19, 2025
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    EOQ
    UDI-DI
    00879123008565
    PMA / PMN Number
    K183256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE HAS NOT YET BEEN RETURNED TO VERATHON FOR EVALUATION. AT THE TIME OF THIS REPORT, THE DEVICE IS STILL PENDING RETURN FROM THE FACILITY. AS A RESULT, THE INVESTIGATION IS ONGOING AND THE CAUSE OF THE REPORTED IMAGE ISSUE HAS NOT BEEN DETERMINED. VERATHON REVIEWED COMPLAINT HISTORY FOR LOT KS251800 AND DID NOT IDENTIFY ANY SIMILAR COMPLAINTS ASSOCIATED WITH THIS LOT. TRENDING ANALYSIS FOR THE BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE DOES NOT IDENTIFY ANY TRENDS EXCEEDING ACCEPTABLE LIMITS. VERATHON CONFIRMED THAT THE RISK ASSOCIATED WITH THE REPORTED SCENARIO HAS BEEN ADEQUATELY CAPTURED AND CHARACTERIZED PER THE SYSTEM RISK ASSESSMENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    B4, D9, G3, G4, G6, H2, H3, H6, H11. THE CUSTOMER'S BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE WAS RETURNED TO VERATHON FOR EVALUATION ALONG WITH THE GLIDESCOPE CORE 15-INCH FHD MONITOR AND TWO (2) GLIDESCOPE CORE 2M QUICKCONNECT CABLES USED DURING THE REPORTED EVENT. A VERATHON TECHNICAL SERVICE REPRESENTATIVE (TSR) EVALUATED THE RETURNED DEVICES BUT WAS UNABLE TO CONFIRM THE REPORTED IMAGE ISSUE. FIRST, WHEN CONNECTING THE CUSTOMER'S MONITOR TO VERATHON'S TEST EQUIPMENT, THE TSR TRIED WIGGLING THE CONNECTIONS, DETACHING AND REATTACHING THE TEST DEVICES, POWER-CYCLING THE MONITOR WITH TEST DEVICES ATTACHED, AND SWAPPING THE TEST DEVICES BETWEEN THE A AND B PORTS. NO IMAGE ISSUES WERE OBSERVED WITH THE CUSOTMER'S MONITOR. NEXT, THE CUSTOMER'S CABLES WERE TESTED BUT NO IMAGE ISSUES WERE FOUND. LASTLY, THE CUSTOMER'S BFLEX WAS TESTED AND AGAIN, NO IMAGE ISSUES WERE OBSERVED. ALL OF THE CUSTOMER'S DEVICES PASSED VERATHON'S DEVICE FUNCTIONALITY TESTING AND CONFIRMED TO BE WITHIN SPECIFICATION. UPON COMPLETION OF VERATHON'S DEVICE EVALUATION, THE MONITOR AND BOTH CABLES WERE RETURNED TO THE CUSTOMER. THE BFLEX WAS SCRAPPED DUE TO BEING A SINGLE-USE DEVICE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. VERATHON WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT DURING A BRONCHOSCOPY PROCEDURE IN THE ICU USING A BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE WITH A GLIDESCOPE CORE 15-INCH FHD MONITOR, THE BRONCHOSCOPE IMAGE WENT BLACK AND DISPLAYED COLORED LINES. THE BRONCHOSCOPE WAS REMOVED FROM THE AIRWAY AND CLEANED, BUT THE ISSUE PERSISTED. THE DEVICE WAS TAKEN OUT OF SERVICE, AND THE PROCEDURE WAS COMPLETED USING A NEW BRONCHOSCOPE FROM A DIFFERENT LOT. NO HARM TO THE PATIENT WAS REPORTED. THE FACILITY ATTEMPTED TO RECREATE THE ISSUE USING THE SAME AND DIFFERENT COMPONENTS BUT WAS UNABLE TO REPLICATE THE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431867 BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE BRONCHOSCOPE EOQ VERATHON MEDICAL ULC 0570-0423 KS251800 00879123008565

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown