BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE

    MDR report key: 10420106 · Received August 18, 2020

    Report

    Report Number
    9615393-2020-00156
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    July 21, 2020
    Report Date
    July 21, 2020
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    EOQ
    UDI-DI
    00879123006332
    PMA / PMN Number
    K183256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D9, G3, G6, H2, H3, H6, H10 THE GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE WAS RETURNED TO VERATHON FOR EVALUATION. A VERATHON TECHNICAL SERVICE REPRESENTATIVE EVALUATED THE RETURNED BFLEX 5.0 AND CONFIRMED THE NO IMAGE ISSUE. THE TECHNICAL SERVICE REPRESENTATIVE FOUND THAT WHEN THE B-FLEX 5.0 WAS CONNECTED TO A WORKING CORE 10" MONITOR AND A QUICKCONNECT CABLE, THE LIGHT POWERED ON BRIEFLY BUT STOPPED WORKING WITHIN FIVE (5) SECONDS. THE CORE 10" MONITOR INDICATED A USER CAMERA ATTACHMENT WAS NEEDED EVEN THOUGH THE BFLEX 5.0 WAS SECURELY ATTACHED. THE GLIDESCOPE BFLEX 5.0 BRONCHOSCOPE WAS SENT TO ENGINEERING FOR FURTHER INVESTIGATION. FURTHER INVESTIGATION CONFIRMED THE CORE 10" MONITOR WAS UNABLE TO RECEIVE A VIDEO FEED FROM THE GLIDESCOPE BFLEX 5.0 VIA THE QUICKCONNECT CABLE EVEN THOUGH THE BFLEX WAS RECEIVING POWER FROM THE CORE 10" MONITOR AS THE LED TIP WAS TURNED ON FOR A SHORT PERIOD. THE ROOT CAUSE OF THE CUSTOMER COMPLAINT IS DUE TO A DEFECTIVE ONANON RECEPTACLE COMPONENT THAT HAS PIN 5 AND PIN 6 SOLDERED TOGETHER ON THE RECEPTACLE'S PCBA. THIS PROBLEM HAS BEEN DEEMED TO HAVE A RISK RATING OF R1 WHICH IS AN ACCEPTABLE RISK.

    Additional Manufacturer Narrative · 1

    THE GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE WAS RECEIVED BY VERATHON INC ON 30 JUL 2020 BUT HAS NOT YET BEEN ANALYZED. VERATHON CONTINUES TO INVESTIGATE THE REPORTED EVENT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE, THE DEVICE WOULD NOT GENERATE AN IMAGE. IT WAS REPORTED THAT OTHER BRONCHOSCOPES IN THE SAME BOX WERE WORKING FINE. AN UNSPECIFIED DELAY IN THE PROCEDURE OCCURRED AS ANOTHER GLIDESCOPE BFLEX 5.0 BRONCHOSCOPE WAS OBTAINED. NO HARM TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883059 GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ VERATHON MEDICAL ULC 0570-0374 FS202001 00879123006332

    Patients

    Seq Age Sex Outcome Treatment
    1