BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINELLE DTX SYSTEM

    MDR report key: 16587900 · Received March 21, 2023

    Report

    Report Number
    3014834623-2023-00004
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    May 4, 2021
    Report Date
    March 21, 2023
    Manufacturer
    UVISION 360, INC.
    Product Code
    FAJ
    UDI-DI
    00853277008046
    PMA / PMN Number
    K181909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER THE PRODUCT MALFUNCTIONED, THE SURGEON WAS ABLE TO PERFORM 2 IUD REMOVAL PROCECDURES SUCCESSFULLY LATER IN THE DAY WITH NO ERRORS. UVISION360, INC. (HEREAFTER UVISION) PERFORMED VISUAL INSPECTION ON THE RETURNED PRODUCT AT THE UVISION OFFICE. THE DEVICE WAS PUT TOGETHER FOLLOWING THE IFU AND PERFORMED AS INTENDED. 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 FEBRURARY 2023, THE INSPECTOR ISSUED AN FDA 483 IDENTIFYING THIS COMPLAINT AS A REPORTABLE MALFUNCTION. ADDITIONAL RESEARCH WAS PERFORMED IN THE MAUDE DATABASE FOR PRODUCT CODE FAJ AND IT WAS FOUND THAT EVENTS HAD BEEN REPORTED FOR SIMILAR DEVICES UNDER THIS PRODUCT CODE.

    Description of Event or Problem · 0

    IN A PRE-SALE DEMONSTRATION, THE SURGEON WAS USING THE LUMINELLE DTX SYSTEM FOR A CYSTOSCOPY PROCEDURE AND THE SALES REPRESENTATIVE REPORTED THAT THE VISIBILITY WAS VERY DARK. THE SALES REPRESENTATIVE AND SURGEON SAID THAT IT WAS DIFFICULT TO VIEW THE BLADDER UNLESS THE SCOPE WAS VERY CLOSE TO THE BLADDER WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938135 LUMINELLE DTX SYSTEM HYSTEROSCOPE WITH SHEATH FAJ UVISION 360, INC. 20030 REV 03 29726 00853277008046

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female