BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLARGEN 2100S TRANSYMOCARDIAL REVASCULARIZATION LASER CONSOLE

    MDR report key: 4352883 · Received December 22, 2014

    Report

    Report Number
    2950727-2014-00027
    Event Type
    Malfunction
    Date Received
    December 22, 2014
    Date of Event
    December 11, 2014
    Report Date
    December 11, 2014
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    THE LASER INVOLVED WAS THE SOLARGEN CONSOLE SERIAL NUMBER (B)(4). THE SYSTEM GENERATED THE ERROR 16 (WHICH INDICATES THE ENERGY DELIVERED FORM THE HOLMIUM LASER WAS TOO HIGH) WHEN THE HOSPITAL FIRST TURNED ON THE UNIT PRIOR TO DOING THE CASE. THE HOSPITAL THEN RESTARTED THE LASER SYSTEM AND WAS ABLE TO COMPLETE THE CASE WITHOUT ANY ERROR CODES. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CRYOLIFE REPRESENTATIVE. THE HOSPITAL HAS NOT HAD AN ERROR 16 WITH THE CONSOLE BEFORE. THE HOSPITAL HAS NOT HAD CRYOLIFE SERVICE THIS CONSOLE AFTER THE APPEARANCE OF ERROR 16, TO DATE. THE HOSPITAL DOES NOT HAVE A SERVICE AGREEMENT WITH CRYOLIFE AND THE HOSPITAL'S BIOMEDICAL DEPARTMENT HAS HISTORICALLY TAKEN CARE OF ALL THE SERVICING NEEDS OF THE CONSOLE. THE ERROR CAUSED A DELAY IN THE SURGERY. A REVIEW OF MANUFACTURING RECORDS FOR LASER CONSOLE (B)(4) WAS PERFORMED IN RESPONSE TO THIS COMPLAINT. ACCORDING TO THE DEVICE HISTORY RECORD (DHR) FOR SOLARGEN CONSOLE (B)(4), ALL MANUFACTURING PROCEDURES AND FINAL TESTING PERFORMED AT NEW STAR LASER ARE DOCUMENTED AS BEING COMPLETED AND VERIFIED BY NEW STAR'S QUALITY CONTROL DOCUMENT PRIOR TO ITS RELEASE. THE SYSTEM IS DOCUMENTED AS BEING ABLE TO PROCEED THROUGH THE START-UP SEQUENCE SUCCESSFULLY, AND CALIBRATION WAS COMPLETED. ALL TESTS RESULTS RECORDED FROM THE CALIBRATION TESTS ARE WITHIN SPECIFICATION SHOWING THE LASER CONSOLE WAS FUNCTIONING PROPERLY AT THE TIME OF RELEASE FOR DISTRIBUTION. THERE ARE NO NON-CONFORMANCES OR REWORKS INCLUDED IN THE RECORDS. SINCE THE ACCOUNT DOES NOT HAVE A CURRENT SERVICE AGREEMENT WITH CRYOLIFE, CRYOLIFE HAS NO WAY TO DETERMINE IF THE LASER HAS BEEN PROPERLY SERVICED AND CALIBRATED TO THE RECOMMENDED SPECIFICATIONS. THE ROOT CAUSE FOR THIS COMPLAINT IS UNKNOWN BUT IS MOST LIKELY THE LASER WAS NOT MAINTAINED PER RECOMMENDATIONS BY CRYOLIFE. THE IFU STATES, "NON-ROUTINE MAINTENANCE AND ALL SERVICING OF THE SOLARGEN 2100S LASER SUCH AS INSTALLATION, CALIBRATION AND REPAIR SHOULD ONLY BE PERFORMED BY AUTHORIZED REPRESENTATIVES. IT IS RECOMMENDED THAT MAINTENANCE OF THE SOLARGEN 2100S LASER CONSOLE, INCLUDING SYSTEM CALIBRATION BE PERFORMED TWICE ANNUALLY." THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT CRYOLIFE.

    Description of Event or Problem · 1

    THE LASER INVOLVED WAS THE SOLARGEN CONSOLE SERIAL NUMBER (B)(4). THE SYSTEM GENERATED THE ERROR 16 (WHICH INDICATES THE ENERGY DELIVERED FORM THE HOLMIUM LASER WAS TOO HIGH) WHEN THE HOSPITAL FIRST TURNED ON THE UNIT PRIOR TO DOING THE CASE. THE HOSPITAL THEN RESTARTED THE LASER SYSTEM AND WAS ABLE TO COMPLETE THE CASE WITHOUT ANY ERROR CODES.

    Description of Event or Problem · 1

    THE LASER INVOLVED WAS THE SOLARGEN SERIAL # (B)(4). THE SYSTEM GENERATED THE ERROR #16 WHEN THEY FIRST TURNED ON THE UNIT PRIOR TO DOING THE CASE, THEY THAN RESTARTED THE LASER SYSTEM AND WAS ABLE TO COMPLETE THE CASE WITHOUT ANY ERROR CODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842378 SOLARGEN 2100S TRANSYMOCARDIAL REVASCULARIZATION LASER CONSOLE TRANSMYOCARDIAL REVASCULARIZATION LASER SYSTEM MNO CARDIOGENESIS CORPORATION SG-2100S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other