BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINELLE DTX SYSTEM

    MDR report key: 16587898 · Received March 21, 2023

    Report

    Report Number
    3014834623-2023-00002
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    July 24, 2020
    Report Date
    March 21, 2023
    Manufacturer
    UVISION 360, INC.
    Product Code
    HIH
    UDI-DI
    00853227708019
    PMA / PMN Number
    K181909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UVISION 360, INC. (HEREAFTER UVISION) PERFORMED FUNCTIONAL TESTING AT THE UVISION OFFICE. A VISUAL INSPECTION OF THE RETURNED PRODUCT AS WELL AS PRODUCT IN STOCK WAS PERFORMED. A TESTING OF THE RETURNED PRODUCT PER IFU INSTRUCTIONS, TESTING OF THE MECHANICAL COMPONENTS, AND TESTING OF THE ELECTRICAL COMPONENTS OF THE RETURNED PRODUCT WERE ALSO PERFORMED. THE DEVICE PERFORMED AS INTENDED, AND NO ERRORS WERE FOUND. THE MALFUNCTION REPORTED BY THE USER WAS NOT ABLE TO BE REPLICATED BY THE UVISION TEAM. UVISION DEVELOPED AN ACTION PLAN IN THE CASE THE PROBLEM RECURS. UVISION DID NOT CONSIDER THIS A MEDICAL DEVICE REPORTABLE EVENT AND THEREFORE DID NOT REPORT THIS COMPLAINT WHEN INITIALLY RECEIVED DUE TO THE FOLLOWING: AFTER INVESTIGATION AND INSPECTIONS OF THE RETURNED PRODUCT, THERE WAS NO EVIDENCE THE DEVICE WAS DEFECTIVE. NO PATIENT HARM WAS OBSERVED AS A RESULT OF THE MALFUNCTION. BASED ON THE MEDICAL ADVISOR'S QUALIFIED OPINION, THIS MALFUNCTION WAS UNLIKELY TO CAUSE SERIOUS HARM OR DEATH TO A PATIENT IF THIS MALFUNCTION WERE TO RECUR. THE MALFUNCTION WAS EVALUATED AS A POSSIBLE HAZARDOUS SITUATION AND FAILURE MODE OF THE DEVICE THROUGH THE PRODUCT HAZARD ANALYSIS AND DFMEA. ALL RISKS ASSOCIATED WITH THIS MALFUNCTION WERE DEEMED ACCEPTABLE. THE MAUDE DATABASE WAS REVIEWED FOR THE PRODUCT CODE HIH AND IT WAS FOUND THAT NO EVENTS WERE REPORTED FOR SIMILAR DEVICES, AS DEFINED BY FDA GUIDANCE "MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF 2016." FOLLOWING AN FDA ROUTINE INSPECTION PERFORMED IN FEBRUARY 2023, THE INSPECTOR ISSUED AN FDA 483 IDENTIFYING THIS COMPLAINT AS A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    THE IMAGE FROM THE LUMINELLE SYSTEM SCOPE'S CAMERA, DISPLAYED ON THE MONITOR, WAS EXPERIENCING INTERMITTENT FREEZING WHEN THE SCOPE WAS BEING MANIPULATED. THIS DEVICE PROBLEM WAS NOTICED DURING PATIENT USE AND BY INFORMAL TESTING BY THE DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937260 LUMINELLE DTX SYSTEM HYSTEROSCOPE WITH SHEATH HIH UVISION 360, INC. 20030 REV02 21199 00853227708019

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female