BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE

    MDR report key: 22720783 · Received August 5, 2025

    Report

    Report Number
    9615393-2025-00086
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 16, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE WAS NOT RETURNED TO VERATHON FOR EVALUATION. SINCE THE DEVICE WAS NOT MADE AVAILABLE FOR ANALYSIS, THE EXACT CAUSE OF THE REPORTED IMAGE ISSUE COULD NOT BE DETERMINED. REVIEW OF COMPLAINT HISTORY FOR LOT KS250904 DID NOT IDENTIFY ANY OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. VERATHON CONFIRMED THAT THE RISK ASSOCIATED WITH THE REPORTED SCENARIO HAS BEEN ADEQUATELY CAPTURED AND CHARACTERIZED IN THE SYSTEM RISK ASSESSMENT. TRENDING ANALYSIS FOR THE BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE DOES NOT IDENTIFY ANY TRENDS EXCEEDING ACCEPTABLE LIMITS. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. VERATHON WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    B4, D9, G3, G6, H2, H3, H6, H11. THE SUBJECT BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE WAS RETURNED TO VERATHON FOR EVALUATION. A VERATHON TECHNICAL SERVICE REPRESENTATIVE (TSR) EVALUATED THE RETURNED DEVICE BUT WAS UNABLE TO CONFIRM THE REPORTED IMAGE ISSUE. WHEN CONNECTED TO VERATHON'S TEST EQUIPMENT, THE FAILURE COULD NOT BE DUPLICATED. THE SYSTEM WAS POWERED WITH THE BFLEX FOR OVER TEN (10) MINUTES WITHOUT ISSUE. THE BFLEX CONNECTION WAS MANIPULATED BUT STILL NO IMAGE ISSUES WERE OBSERVED. THE BFLEX PASSED BOTH VISUAL INSPECTION AND VERATHON'S DEVICE FUNCTIONALITY TESTING AND CONFIRMED TO BE WITHIN SPECIFICATION. THE MONITOR AND CABLE THAT WERE CONNECTED TO THE BFLEX DURING THE REPORTED INCIDENT WERE NOT MADE AVAILABLE TO VERATHON FOR EVALUATION. UPON COMPLETION OF VERATHON'S DEVICE EVALUATION, 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 PATIENT PROCEDURE, A BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE WAS PLUGGED IN ALONGSIDE A LARYNGOSCOPE BLADE FOR APPROXIMATELY 10 MINUTES DURING CASE SETUP. WHEN THE CASE BEGAN, THE CRNA SELECTED THE BFLEX 2 REGULAR 5.0 SCOPE TO INTUBATE A PATIENT WITH A KNOWN DIFFICULT AIRWAY. THE SCOPE WAS CONFIRMED TO BE POWERED ON WITH AN IMAGE VISIBLE PRIOR TO USE. UPON INSERTION INTO THE PATIENT'S NOSE, THE IMAGE BRIEFLY TURNED RED/GREEN AND THEN IMMEDIATELY WENT BLACK. THE CRNA UNPLUGGED THE SCOPE AND COMPLETED THE INTUBATION USING A MAC3 BLADE, WHICH REMAINED CONNECTED THROUGHOUT. THE BLADE VIDEO WAS NOT IN USE AT THE TIME OF THE ISSUE (NOT A DUAL-VIEW SETUP). A VERATHON CLINICAL SPECIALIST WAS PRESENT IN THE ROOM, RETAINED THE AFFECTED SCOPE, AND ATTEMPTED TO RECREATE THE REPORTED ISSUE MULTIPLE TIMES WITHOUT SUCCESS. AN ADDITIONAL ATTEMPT TO REPLICATE THE BEHAVIOR WAS CONDUCTED THE FOLLOWING MORNING, AGAIN WITH NO RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431866 BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE BRONCHOSCOPE EOQ VERATHON MEDICAL ULC 0570-0423 KS250904 00879123008565

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown