BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINELLE DTX SYSTEM

    MDR report key: 17552746 · Received August 15, 2023

    Report

    Report Number
    3014834623-2023-00010
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    December 2, 2022
    Report Date
    December 6, 2022
    Manufacturer
    UVISION 360, INC.
    Product Code
    FAJ
    UDI-DI
    10853277008012
    PMA / PMN Number
    K181909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHYSICAL DAMAGED OCCUR TO THE BLUE SCOPE STICK IS THE CAUSE THE FAILURE TO THE IMAGE LIGHT. ALTHOUGH THE SCOPE IS INTENDED TO BE FLEXIBLE, EXCESSIVE BENDING CAN DAMAGE THE FIBEROPTICS BUNDLES AND THE INTERNAL COMPONENTS. SUCH DAMAGE WILL COMPROMISE THE LIGHT ILLUMINATING FIBERS AT THE DISTAL END OF THE SCOPE. THE DAMAGE TO THE FIBEROPTICS CAN OCCUR WHEN A USER MISHANDLES THE PRODUCT. THERE WERE NO REPORTS OF PATIENT HARM. WHEN THIS COMPLAINT WAS REPORTED, UVISION 360 DID NOT CONSIDER THIS A MEDICAL DEVICE REPORTABLE EVENT AND THEREFORE BASED ON THE RISK OF THIS COMPLAINT AT THE TIME OF OCCURRENCE, DID NOT REPORT THIS COMPLAINT. UPON FURTHER EVALUATION, IT WAS IDENTIFIED THAT THIS EVENT OCCURRED DURING PATIENT USE AND THEREFORE IT IS NOW CONSIDERED REPORTABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE SCREEN WHERE THE IMAGE WAS SUPPOSED TO DISPLAY WAS DARK DURING USE OF THE DEVICE. WHEN THE DEVICE WAS RECEIVED BACK TO UVISION 360, THERE APPEARED TO BE DAMAGE TO THE SCOPE STICK. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1793149 LUMINELLE DTX SYSTEM CYSTOSCOPE FAJ UVISION 360, INC. 20040 10853277008012

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female