BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINELLE DTX SYSTEM

    MDR report key: 17552750 · Received August 15, 2023

    Report

    Report Number
    3014834623-2023-00013
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    August 1, 2023
    Report Date
    August 1, 2023
    Manufacturer
    UVISION 360, INC.
    Product Code
    FAJ
    UDI-DI
    00853277008046
    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

    AS OF THE TIME OF THIS SUBMISSION, UVISION HAS NOT YET RECEIVED THE SYSTEM FOR A FULL INVESTIGATION. SINCE THIS EVENT WAS REPORTED BY THE SAME FACILITY AS PREVIOUS COMPLAINT, WHICH WAS ATTRIBUTED TO THE USE OF INCOMPATIBLE ISNTRUMENTS WITH TEH DEVICE, BASED ON THE TIMING OF THIS REPORT, IT IS BELIEVED THAT THE ROOT CAUSE IS THE SAME. ONCE THE DEVICE IS RECEIVED, UVISION WILL PERFORM AN INVESTIGATION AND IF A NEW ROOT CAUSE IS IDENTIFIED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED. A NOTIFICATION WAS SENT TO ALL CUSTOMERS AS A REMINDER OF THE POSSIBLE DAMAGE THAT CAN OCCUR WHEN USING INCOMPATIBLE INSTRUMENTS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY NOTICED THE BLUE CASING OF THE SCOPE IS STARTING TO TEAR. THEY REPORTED THE SCOPE HAD ONLY BEEN USED IN TWO CASES. THE CUSTOMER PROVIDED PHOTOS OF THE PHYSICAL DAMAGE TO THE SCOPE STICK. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1793153 LUMINELLE DTX SYSTEM CYSTOSCOPE FAJ UVISION 360, INC. 20030 00853277008046

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female