BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINELLE DTX SYSTEM

    MDR report key: 16587903 · Received March 21, 2023

    Report

    Report Number
    3014834623-2023-00003
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    September 11, 2020
    Report Date
    March 21, 2023
    Manufacturer
    UVISION 360, INC.
    Product Code
    HIH
    UDI-DI
    10853277008029
    PMA / PMN Number
    K181909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    UVISION 360, INC. (HEREAFTER UVISION) PERFORMED FUNCTIONAL TESTING AT THE UVISION 360 OFFICE. THE DEVICE DID NOT PERFORM AS INTENDED, HOWEVER, THE ISSUE HAD ALREADY BEEN ADDRESSED BY UVISION THROUGH AN UPDATE TO THE DESIGN. THIS IMPROVEMENT WAS RELEASED AFTER THE SALE DATE OF THIS SYSTEM. UVISION DID NOT CONSIDER THIS A MEDICAL DEVICE REPORTABLE EVENT AND THEREFORE DID NOT REPORT THIS COMPLAINT WHEN INITIALLY RECEIVED DUE TO THE FOLLOWING: THE MALFUNCTION WAS AN ISOLATED EVENT AS THE IMPROVEMENT WAS RELEASED TO ADDRESS THE MALFUNCTION TYPE AFTER THE MALFUNCTION OCCURRED. 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.

    Description of Event or Problem · 0

    DR. MACHIN WAS PERFORMING AN IUD REMOVAL AND THE IMAGE ON THE MONITOR WENT OUT. THE STAFF WAS ABLE TO MOVE THE CORD AND THE IMAGE RE-APPEARED TO COMPLETE THE PROCEDURE. THE PATIENT HAS BEEN REPORTED AS DOING FINE. THE PHYSICIAN REPORTED NO INJURY OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938138 LUMINELLE DTX SYSTEM HYSTEROSCOPE WITH SHEATH HIH UVISION 360, INC. 20050 REV 01 22363 10853277008029

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female