BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINELLE DTX SYSTEM

    MDR report key: 17552729 · Received August 15, 2023

    Report

    Report Number
    3014834623-2023-00008
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    June 26, 2019
    Report Date
    June 26, 2019
    Manufacturer
    UVISION 360, INC.
    Product Code
    FAJ
    UDI-DI
    00853277008046
    PMA / PMN Number
    K181909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED WHICH DETERMINED THAT THE ROOT CAUSE OF THE MALFUNCTION WAS DUE TO DAMAGE TO THE FIBER OPTIC STICK. THE CAUSE OF DAMAGE TO THE FIBER OPTIC STICK WAS DUE TO APPARENT MISUSE BY THE CUSTOMER. NO PATIENT HARM WAS REPORTED DUE TO THIS MALFUNCTION. 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 THEY WERE EXPERIENCING INTERMITTENT IMAGES FROM THE SCOPE ON THE MONITOR. THE CUSTOMER SENT IMAGES OF A PHYSICAL DAMAGE THEY NOTICE AS WELL. CLEAR DAMAGE TO THE FIBER OPTIC STICK WAS VISIBLE IN THE IMAGES. THE FIBER OPTIC CABLE WAS VISUALLY AND FUNCTIONALLY TESTED TO CONFIRM THE PHYSICAL AND FUNCTIONAL DAMAGE SEEN BY THE CUSTOMER. THE USAGE COMMUNICATED BY THE CUSTOMER WAS RECREATED IN AN ATTEMPT TO RECREATE THE DAMAGE. THE DAMAGE COULD NOT BE RECREATED USING THE SAME INSTRUMENTATION USED WITH THE DEVICE. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792713 LUMINELLE DTX SYSTEM CYSTOSCOPE FAJ UVISION 360, INC. 20030 REV 02 00853277008046

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female