BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINELLE DTX SYSTEM

    MDR report key: 16587901 · Received March 21, 2023

    Report

    Report Number
    3014834623-2023-00005
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    December 8, 2021
    Report Date
    March 21, 2023
    Manufacturer
    UVISION 360, INC
    Product Code
    HIH
    UDI-DI
    00853277008046
    PMA / PMN Number
    K181909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    UVISION 360 COMPLETED THE TECHNICAL INSPECTION OF THE LUMINELLE® DTX SYSTEM RECEIVED. AFTER REVIEWING THE RECEIVED SYSTEM AND PERFORMING FUNCTIONAL CHECKS, IT WAS DETERMINED THAT THE RECEIVED SCOPE WAS FUNCTIONING AS INTENDED AND NO PHYSICAL DAMAGE WAS SHOWN. WHEN ATTACHING VARIOUS SHEATHS TO THE SCOPE IT WAS FOUND THAT MINIMAL LATERAL FORCE COULD DISLODGE THE CONNECTING FINGERS, CAUSING THE MALFUNCTION THE USER WAS EXPERIENCING. UVISION DID NOT CONSIDER THIS A MEDICAL DEVICE REPORTABLE EVENT AND THEREFORE DID NOT REPORT THIS COMPLAINT WHEN INITIALLY RECEIVED DUE TO THE FOLLOWING: NO PATIENT HARM WAS OBSERVED AS A RESULT OF THE MALFUNCTION. THE MALFUNCTION COULD RESULT IN A FLUID LEAK, BUT THIS WOULD NOT RESULT IN ANY PATIENT HARM. 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 (B)(6) 2023, THE INSPECTOR ISSUED AN FDA 483 IDENTIFYING THIS COMPLAINT AS A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    SCOPE AND SHEATH(S) DO NOT CONSISTENTLY ATTACH TO THE DEVICE. WHILE CONDUCTING PROCEDURES, THE SCOPE AND SHEATH(S) BECOME DISLODGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938136 LUMINELLE DTX SYSTEM HYSTEROSCOPE WITH SHEATH HIH UVISION 360, INC 20030 REV 08 32366 00853277008046

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female