BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINELLE DTX SYSTEM

    MDR report key: 17552749 · Received August 15, 2023

    Report

    Report Number
    3014834623-2023-00012
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    July 10, 2023
    Report Date
    July 27, 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

    BASED ON INVESTIGATION, PHYSICIAN USED TWO SETS OF INCOMPATIBLE SCISSORS RESULTING TO PHYSICAL DAMAGE ON THE BLUE SCOPE STICK, WHICH CAUSED THE FAILURE OF 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 AND USES INCOMPATIBLE INSTRUMENTS. THERE WERE NO REPORTS OF PATIENT HARM. 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 THE LOANER SCOPE WAS DAMAGED DURING A PATIENT PROCEDURE. THE CUSTOMER EXPLAINED THAT THERE WAS SEVERE DAMAGE TO THE BLUE SCOPE STICK, BUT DID NOT SPECIFY HOW THE DAMAGE OCCURRED. THERE WERE NO PATIENT ADVERSE EVENTS DUE TO THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1793152 LUMINELLE DTX SYSTEM CYSTOSCOPE FAJ UVISION 360, INC. 20030 00853277008046

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female