BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLARGEN 2100S TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE

    MDR report key: 3775941 · Received April 28, 2014

    Report

    Report Number
    2950727-2014-00010
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SECOND EVALUATION WAS HELD AND THE ORIGINAL RETURNED FOOT PEDAL WAS AGAIN VISUALLY INSPECTED. IT WAS CONNECTED TO AN OLD-MODEL SOLARGEN 2100S CONSOLE WITH THE 5-PIN CONNECTED TO TEST THE FUNCTIONALITY AND PASSED THE FOOT PEDAL SHUTTER TEST; THE FOOT PEDAL WAS CONFIRMED TO BE FUNCTIONAL. THE FEMALE SIDE OF THE CONNECTOR DID NOT ESTABLISH GOOD CONTACT PROPERTIES WHICH IS WHY THE CUSTOMER HAD TO PUSH ON THE CONNECTOR TO COMPLETE THE CASE. THE FIELD SERVICE ENGINEER REPLACED THE CONNECTOR ASSEMBLY WITH THE NEWEST REVISION, WHICH ALSO INCLUDED THE NEW STYLE FOOT PEDAL WITH THE LOCKING CONNECTOR.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: MODEL NUMBER, WAS CORRECTED TO LSR-SG2100S. ACCORDING TO THE REPORT, THE FOOT PEDAL TO THE SOLARGEN 2100S CONSOLE WAS NOT OPERATIONAL. SURGERY WAS PROLONGED, BUT THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE. THE FOOT PEDAL WAS RETURNED; HOWEVER, IT COULD NOT BE CONNECTED TO A SOLARGEN 2100S CONSOLE TO TEST THE FUNCTIONALITY AS THE SOLARGEN 2100S CONSOLE ON SITE HAS THE NEWEST REVISION OF THE CONNECTOR ASSEMBLY AND IS NOT COMPATIBLE WITH THIS FOOT PEDAL. THE CUSTOMER WAS SENT A REPLACEMENT FOOT PEDAL THAT INCORPORATED THE FIVE-PIN CONNECTOR, BUT AFTER THE CUSTOMER INSTALLED THE REPLACEMENT FOOT PEDAL THE LASER CONSOLE STILL DID NOT WORK. AN EMERGENCY SERVICE CALL WAS SCHEDULED TO ADDRESS THE ISSUE. THE SERVICE ENGINEER FOUND THE FEMALE SIDE OF THE CONNECTOR WAS NOT RECOGNIZING THE MALE PORTION OF THE FOOT PEDAL CONNECTOR. THE FEMALE SIDE OF THE CONNECTOR DID NOT ESTABLISH GOOD CONTACT PROPERTIES WHICH IS WHY THE CUSTOMER HAD TO PUSH ON THE CONNECTOR TO COMPLETE THE CASE. THE FIELD SERVICE ENGINEER REPLACED THE CONNECTOR ASSEMBLY WITH THE NEWEST REVISION, WHICH ALSO INCLUDED THE NEW STYLE FOOT PEDAL WITH THE LOCKING CONNECTOR. UPGRADING TO THE NEW LOCKING STYLE CONNECTOR SHOULD ELIMINATE FURTHER FOOT PEDAL ISSUES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE FOOT PEDAL TO THE SOLARGEN 2100S CONSOLE WAS NOT OPERATIONAL. SURGERY WAS PROLONGED, BUT THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE FOOT PEDAL TO THE SOLARGEN 2100S CONSOLE WAS NOT OPERATIONAL. SURGERY WAS PROLONGED, BUT THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE FOOT PEDAL TO THE SOLARGEN 2100S CONSOLE WAS NOT OPERATIONAL. SURGERY WAS PROLONGED, BUT THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253873 SOLARGEN 2100S TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE TRANSMYOCARDIAL REVASCULARIZATION LASER SYSTEM MNO CARDIOGENESIS CORPORATION LSR-SG2100S VEG02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other