BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2161013 · Received June 17, 2011

    Report

    Report Number
    2028159-2011-00690
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 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
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE LASER SYSTEM AND WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED EVENT. THE COMPANY REPRESENTATIVE REPLACED THE KEYSWITCH CABLE ASSEMBLY AND THE PROBE DETECTOR PRINTED CIRCUIT BOARD (PCB) FOR DIAGNOSTIC PURPOSES. THE LASER SYSTEM WAS THEN TESTED AND MET PRODUCT SPECIFICATIONS. THE KEYSWITCH CABLE ASSEMBLY AND THE PROBE DETECTOR PCB WAS RETURNED FOR EVALUATION. ADDITIONAL INFORMATION REGARDING PRODUCT EVALUATION IS PENDING. 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 REPORTED THAT DURING SURGERY, THE LASER WOULD NOT TURN ON. THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED WITH NO HARM TO THE PATIENT.

    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