BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3915555 · Received June 4, 2014

    Report

    Report Number
    2028159-2014-01066
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 4, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SAMPLE WAS RETURNED AND EXAMINED USING 25 X MAGNIFICATION. THE NEEDLE WAS SEVERELY BENT AT THE PROBE BODY. ASPIRATION TESTING WAS PERFORMED AND FOUND TO BE CONFORMING. ACTUATION TESTING WAS PERFORMED AND FOUND TO BE NONCONFORMING (NO MOVEMENT OF THE INNER CUTTER). THE PROBE WAS DISASSEMBLED AND THE COMPONENTS INSPECTED. THERE WAS RESISTANCE FELT WHILE REMOVING THE INNER CUTTER FROM THE SEVERLY BENT NEEDLE. THERE IS 15 - 20 MINUTES OF WEAR ON THE INNER CUTTER WHEN COMPARED TO WEAR VISUAL STANDARDS. THERE ARE WEAR MARKS ON THE INNER CUTTER SHAFT AT THE BEND AREA. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER COMPLAINANT ISSUE WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO ACCEPTANCE CRITERIA. THE ROOT CAUSE FOR THE ACTUATION FAILURE IS THE BENT NEEDLE. HOW OR WHEN THE NEEDLE BECAME BENT CANNOT BE DETERMINED. A BENT NEEDLE WOULD THEN CAUSE THE INNER CUTTER TO BECOME BENT. THE INNER CUTTER WOULD THEN RUB THE OUTER NEEDLE AND IMPEDE THE FUNCTION OF THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A 25G PROBE WAS UNABLE TO ASPIRATE SUDDENLY DURING SURGERY. NO PATIENT HARM WAS REPORTED. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326062 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR LXT-JAPAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PAK, ULTRAVIT 25+ 5000