BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINELLE DTX SYSTEM

    MDR report key: 16587896 · Received March 21, 2023

    Report

    Report Number
    3014834623-2023-00001
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    January 21, 2020
    Report Date
    March 21, 2023
    Manufacturer
    UVISION 360, INC
    Product Code
    HIH
    UDI-DI
    00853277008008
    PMA / PMN Number
    K181909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UVISION 360, INC. (HEREAFTER, UVISION) PERFORMED FUNCTIONAL TESTING AT THE UVISION OFFICE. VISUAL INSPECTION WAS PERFORMED ON THE RETURNED PRODUCT AS WELL AS PRODUCT IN STOCK. TESTING OF THE PRODUCT PER IFU INSTRUCTIONS AND TESTING OF MECHANICAL COMPONENTS WERE COMPLETED ON THE RETURNED PRODUCT. THE SHEATH PERFORMED AS INTENDED, AND THE MALFUNCTION EXPERIENCED BY THE USER COULD NOT BE REPLICATED. 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. 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. FOLLOWING AN FDA ROUTINE INSPECTION PERFORMED IN (B)(6) 2023, THE INSPECTOR ISSUED AN FDA 483 IDENTIFYING THIS COMPLAINT AS A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    FLUID WAS VISIBLY NOT FLOWING THROUGH THE SCOPE'S OUTFLOW FLUID TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937258 LUMINELLE DTX SYSTEM HYSTEROSCOPE WITH SHEATH HIH UVISION 360, INC 20020 REV03 9080 00853277008008

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female