BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2515460 · Received March 29, 2012

    Report

    Report Number
    2028159-2012-00454
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Date of Event
    December 15, 2011
    Report Date
    December 15, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS THE (B)(4) COMPLAINT REPORTED FOR THIS ISSUE. THERE HAVE BEEN NO ADDITIONAL COMPLAINTS REPORTED AGAINST THE FINISH GOODS LOT AND THE DEVICE HISTORY RECORD (DHR) SHOWS THE PRODUCT WAS RELEASED PER SPECIFICATIONS. THE USED RETURNED CASSETTE, WITH MANIFOLD AND TRAY, WERE VISUALLY INSPECTED AND NO OBVIOUS DEFECTS WERE FOUND. SYSTEM CONSOLES, REPRESENTING CURRENT SOFTWARE VERSIONS, WERE USED TO TEST THE SAMPLES. THE SAMPLE PASSED THE PRIMING TEST AND INTRAOCULAR PRESSURE (IOP) CALIBRATION SUCCESSFULLY. THE RINGS ILLUMINATED GREEN AS THE PROBE CONNECTORS WERE INSERTED TO THE PORT ON THE CONSOLE. THE CONNECTION BETWEEN THE PROBE AND THE CONSOLE WAS ESTABLISHED PROPERLY. THE 5000 CPM - CUT- RATE TEST PASSED AS THE PROGRESS BAR REACHED 5000 CPM. THE ULTRA VIT PROBE WAS SUBMERGED INTO WATER. NO LEAKAGE WAS FOUND ON THE FLUID LINE AND THE PROBE ENGINE. NO BUBBLE WAS SEEN FROM THE NEEDLE OF THE PROBE. THE NEEDLE OF THE PROBE REMAINED IN PLACE ON THE PROBE. WHILE TOGGLING THE INFUSION AND THE FLUID/AIR EXCHANGE (F/AX) MODES ON FOOTSWITCH, FLUID AND AIR FLOWED FROM THE CASSETTE TO THE INFUSION LINE CONTINUOUSLY WITHOUT ANY BUBBLE IN VARIOUS SETTINGS. THE DATA OF THE INFUSION, IRRIGATION, AND ASPIRATION PRESSURE WERE COLLECTED BY USING A PRESSURE METER; THE DATA WAS WITHIN SPECIFICATION. NO MESSAGE CODES WERE DISPLAYED ON THE SCREEN. FLUID FLOWED FROM BALANCED SALT SOLUTION (BSS) TO THE DRAIN BAG WITHOUT ANY INTERFERING. NO LEAKAGE WAS DETECTED FROM THE PUMP ELASTOMER OR ON THE PUMP AREA OF THE FLUIDICS MODULE. THE FUNCTIONAL TEST HAD COMPLETED, AND THE CLEANING PROCESS WAS PERFORMED. THE CHECK VALVE WIDTH IN THE DRAIN BAG WAS WITHIN SPECIFICATIONS. THE RADIO FREQUENCY IDENTIFICATION (RFID) PNEU MALE WAS USED TO COLLECT DATA FROM THE RFID CONNECTORS OF THE PROBE. THE DATA OF BLOCK 9 INDICATED THE PROBE COULD REACH 5000 CUT PER MINUTE. THE DATA OF THE PROBE WAS WITHIN SPECIFICATION PER THE DRAWING. THE SAMPLE PASSED THE FUNCTIONAL/PERFORMANCE TEST. EVALUATION PERFORMED ON THE TWO RETURNED VITRECTOMY PROBES RESULTED IN THE FOLLOWING: SAMPLE A WAS FOUND TO BE VISUALLY CONFORMING. SAMPLE B WAS FOUND TO HAVE LOOSE NEEDLE DUE TO FAILURE OF THE BOND BETWEEN THE NEEDLE AND THE SLEEVE STIFFENER. SURGICAL DEBRIS WAS OBSERVED INSIDE THE PORT AND ON THE INNER CUTTER SURFACE. THE INNER CUTTER ALSO EXHIBITED WEAR MARKS INDICATING IT MAY HAVE BEEN USED. FUNCTIONAL TESTING RESULTS ARE AS FOLLOWS: SAMPLE A WAS FOUND TO BE FUNCTIONALLY CONFORMING. NO BUBBLES WERE OBSERVED COMING OUT FROM THE PORT NOR THE ASPIRATION LINE. SAMPLE B WAS FOUND TO BE NONCONFORMING. THE LOOSE NEEDLE WAS "JACK-HAMMERING" DURING ACTUATION. ASPIRATION TEST DID NOT SHOW ANY BUBBLES COMING OUT FROM THE PORT, BUT THERE WERE BUBBLES IN THE ASPIRATION LINE. THE ROOT CAUSE OF THE REPORTED EVENT, TINY BUBBLES CAME OUT OF THE PORT, COULD NOT BE DETERMINED. THE ROOT CAUSE OF THE REPORTED EVENT, NEEDLE COULD MOVE FREELY, IS BOND FAILURE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING SURGERY, TINY BUBBLES CAME OUT OF THE PORT WHILE BOTH ASPIRATION AND CUTTING WERE ON. ALSO THE NEEDLE COULD MOVE FREELY. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION WITH LASER UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER CONSTELLATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CUSTOM PAK