BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 8759126 · Received July 3, 2019

    Report

    Report Number
    2028159-2019-01214
    Event Type
    Malfunction
    Date Received
    July 3, 2019
    Report Date
    October 8, 2019
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    E-STOP CABLE ASSEMBLY WAS RECEIVED FOR EVALUATION. A VISUAL ASSESSMENT OF THE SAMPLE SHOWED THAT THE E-STOP BUTTON WAS BROKEN INTO PIECES AND COULD NOT BE FUNCTIONALLY TESTED. IT WAS VISUALLY CONFIRMED TO BE NONCONFORMING AND NO FURTHER TESTING WAS PERFORMED. HOWEVER, HOW OR WHEN THE LASER E-STOP BUTTON BECAME NONCONFORMING COULD NOT BE DETERMINED CONCLUSIVELY. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A BROKEN LASER EMO STOP CABLE. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO THE LAMP, WHICH EXCEEDED ITS RATED LIFE. HOWEVER, NO PROBLEM WAS FOUND WITH THE LAMP AS IT FUNCTIONED TO ITS EXPECTED RATED LIFE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND REPLICATED THE REPORTED EVENT. THE COMPANY SERVICE REPRESENTATIVE DETERMINED THAT THE LASER (EMERGENCY OFF) EMO SWITCH WAS BROKEN. THE COMPANY SERVICE REPRESENTATIVE REPLACED THE LASER EMO STOP CABLE AND THE XENON LAMP TO RESOLVE THE ISSUES. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE SYSTEM MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A BROKEN LASER EMO STOP CABLE. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO THE XENON LAMP, WHICH EXCEEDED ITS RATED LIFE. HOWEVER, NO PROBLEM WAS FOUND WITH THE XENON LAMP AS IT FUNCTIONED TO ITS EXPECTED RATED LIFE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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 HEALTHCARE PROFESSIONAL REPORTED THE LASER INTERMITTENTLY SHUTS OFF AND THE TABLETOP ILLUMINATION HAS EXCEEDED OPERATIONAL HOURS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555200 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER TABLETOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1