BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PAK

    MDR report key: 19172887 · Received April 24, 2024

    Report

    Report Number
    1644019-2024-00798
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    March 14, 2024
    Report Date
    July 24, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETAIN THE FINISHED GOODS LOT NUMBER SPECIFIC TO THIS EVENT; THEREFORE, DEVICE HISTORY RECORD AND LOT HISTORY COULD NOT BE REVIEWED. THE USED PAK WAS VISUALLY INSPECTED AND NO OBVIOUS DEFECTS WERE FOUND. NO KINK WAS FOUND AT THE ASPIRATION LINE AT THE ENTRANCE OF THE TUBING INSERTION TO THE PROBE ENGINE INSIDE THE REAR SHELL. THE RETURNED PROBE, MANIFOLDS, 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. 10000 CUT RATE DISPLAYED ON THE SCREEN WHEN THE RADIO FREQUENCY IDENTIFICATION (RFID) WAS CONNECTED TO THE CONSOLE. A CALIBRATED CONSOLE REPRESENTING THE CURRENT SOFTWARE VERSION WAS USED TO TEST THE SAMPLE. 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 BALANCE 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. ASPIRATION FLOW RATE WAS MEASURED AND MET SPECIFICATIONS, NO ANOMALIES WERE OBSERVED. WE WERE UNABLE TO REPLICATE THE CUSTOMER'S EXPERIENCE DURING LABORATORY EVALUATION. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE ESTABLISHED; THE RETURNED SAMPLE FUNCTIONED PER SPECIFICATIONS. AFTER INVESTIGATION OF THIS COMPLAINT, IT HAS BEEN DETERMINED THAT THIS SAMPLE FUNCTIONED PER SPECIFICATIONS; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT. 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 HEALTHCARE PROFESSIONAL REPORTED THAT UNUSUAL NOISE FROM OPHTHALMIC CUTTER, A KINK WITHIN THE HANDPIECE OF CUTTER DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY CHANGING A NEW PRODUCT. THERE WAS NO REPORT ON PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948445 CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CUSTOM-PAK SURGICAL PROCEDURE PACK.