BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINELLE DTX SYSTEM

    MDR report key: 16998988 · Received May 24, 2023

    Report

    Report Number
    3014834623-2023-00007
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    April 19, 2023
    Report Date
    May 24, 2023
    Manufacturer
    UVISION 360, INC.
    Product Code
    HIH
    UDI-DI
    10853277008012
    PMA / PMN Number
    K181909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UVISION 360, INC. (HEREAFTER, UVISION) PERFORMED A VISUAL AND FUNCTIONAL TESTING AT THE UVISION OFFICE. THE SCOPE PRESENTED MINOR KINKS TO THE SCOPE COMPONENT THAT WAS CONCLUDED AS THE CAUSE OF THE MALFUNCTION. UVISION ADDITIONALLY REVIEWED THE MANUFACTURING AND INSPECTION RECORDS FOR THE ASSOCIATED DEVICE LOT TO ENSURE THAT THE ENTIRE DEVICE LOT MET ALL ACCEPTANCE CRITERIA PRIOR TO RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINED THAT WHILE USING THE LUMINELLE SYSTEM WITH A PATIENT, THE IMAGE DISPLAYED ON THE MONITOR WAS EXPERIENCING INTERMITTENT IMAGING ISSUES. THESE ISSUES WERE LIMITED DURING SCOPE MANIPULATION. THERE WAS NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760233 LUMINELLE DTX SYSTEM HYSTEROSCOPE WITH SHEATH HIH UVISION 360, INC. 20040 REV02 22498 10853277008012

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female