BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PACK

    MDR report key: 20564945 · Received October 30, 2024

    Report

    Report Number
    1644019-2024-02527
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Report Date
    January 24, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380657524501
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6. AND H.11. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. THE RETURNED SAMPLE WAS VISUALLY INSPECTED AND NO OBVIOUS DEFECTS WERE FOUND. THE NON-INVASIVE FLOW SENSOR (NIFS) ON THE CASSETTE HOUSING WAS IN GOOD CONDITION. A CALIBRATED CONSOLE REPRESENTING THE CURRENT SOFTWARE VERSION WAS USED TO TEST THE SAMPLE. THE DRIP CHAMBER AND PROBE ENGINE WERE CUT OFF FROM THE MANIFOLDS ON RETURNED CONDITION. THE CUT OFF DRIP CHAMBER AND PROBE ENGINE WERE NOT RETURNED. THE TUBING SURFACE INDICATE THAT THE MANIFOLDS WERE CUT OFF. THE INFUSION CANNULA WAS NOT RETURNED. THE PROBE, ADMIN MANIFOLD AND INFUSION CANNULA FROM LAB STOCK WERE USED TO TEST THE RETURNED CASSETTE. THE RETURNED IRRIGATION/ASPIRATION (I/A) MANIFOLD, INFUSION MANIFOLD, CONNECTORS, AND COMPONENTS WERE FOUND TO BE IN GOOD CONDITION. THE CONNECTORS WERE CONNECTED TO THE CASSETTE WITHOUT ANY INTERFERENCE. THE LIGHT-EMITTING DIODE (LED) RINGS ON THE CONSOLE TURNED GREEN AS THE PROBE CONNECTORS WERE ENGAGED TO THE CONSOLE INDICATING THE PROPER COMMUNICATION BETWEEN THE PROBE AND THE CONSOLE. THE USED DRAIN BAG WAS CUT ON THE TOP PORTION CLOSE TO THE INLET VALVE ON THE RETURNED CONDITION. SURGICAL RESIDUE WAS INSIDE THE DRAIN BAG. THERE WAS NO OCCLUSION IN THE DRAIN BAG INLET VALVE. THE FILMS WERE SEALED PROPERLY WITHOUT ANY MISALIGNMENT. THE SAMPLE COULD PRIME AND PASS INTRAOCULAR PRESSURE (IOP) CALIBRATION SUCCESSFULLY. NO ANOMALIES WERE OBSERVED DURING PRIMING. NO SYSTEM MESSAGE CODE WAS GENERATED DURING TESTING. FLUID FLOWED FROM THE BALANCED SALT SOLUTION (BSS) BOTTLE TO THE DRAIN BAG WITHOUT ANY INTERFERING. NO LEAKAGE WAS DETECTED FROM THE PUMP ELASTOMER OR ON THE PUMP AREA OF THE FLUIDICS MODULE. CLEANING PROCESS WAS ABLE TO BE PERFORMED AFTER FUNCTIONAL TEST HAD COMPLETED. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE ESTABLISHED; THE RETURNED SAMPLE FUNCTIONED PER SPECIFICATIONS. AFTER AN INVESTIGATION OF THIS COMPLAINT, IT HAS BEEN DETERMINED THAT THIS SAMPLE FUNCTIONED PER SPECIFICATIONS; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. NO ADVERSE TRENDS HAVE BEEN OBSERVED ASSOCIATED WITH THE REPORTED PRODUCT AND EVENT. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT THE LIQUID-LEAKAGE OCCURRED THROUGH A GAP OF A CASSETTE AND A FLUIDICS MODULE DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043050 CONSTELLATION SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 16U44U 00380657524501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown