BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2102258 · Received May 19, 2011

    Report

    Report Number
    2028159-2011-00567
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 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
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. A SAMPLE HAS BEEN RETURNED, BUT HAS NOT YET BEEN EVALUATED. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THE RADIO FREQUENCY IDENTIFICATION DEVICE TECHNOLOGY (RFID) OF THE ENDOILLUMINATION PROBE WAS NOT DETECTED PRIOR TO SURGERY. DURING SURGERY, A SYSTEM MESSAGE WAS DISPLAYED. THE CUSTOMER REMOVED THE IRRIGATION LINE FROM THE BSS BOTTLE (NON-ALCON PRODUCT) AND NOTED IT WAS OBSTRUCTED BY A PLASTIC FRAGMENT THAT CAME FROM THE RUBBER STOPPER OF THE BSS BOTTLE. AFTER REMOVING THIS FRAGMENT, THE SURGERY WAS COMPLETED. THERE WAS NO PT INJURY 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