BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2121818 · Received May 20, 2011

    Report

    Report Number
    2028159-2011-00563
    Event Type
    Malfunction
    Date Received
    May 20, 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

    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. (B)(4).

    Description of Event or Problem · 1

    A NURSE MANAGER REPORTED THAT THE FIRST SURGICAL PROCEDURE OF THE DAY WAS DELAYED BY SEVERAL EVENTS. SYSTEM MESSAGES APPEARED DURING THE PRIMING STEP AND THE LASER DID NOT WORK. AFTER 3 REBOOTS, THE SYSTEM FINALLY WORKED. THE SURGERY WAS PERFORMED, WITHOUT ANY PROBLEMS. THERE WAS A DELAY OF AN HOUR AND A HALF. PATIENT STAYED IN THE OPERATING ROOM DURING ALL THIS TIME AND WAS UNDER ANESTHESIA. NO PATIENT INJURY WAS 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