BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 3165595 · Received June 12, 2013

    Report

    Report Number
    2950727-2013-00026
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    October 18, 2012
    Report Date
    June 12, 2013
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, THE SURGEON ATTEMPTED TO USE TWO SOLOGRIP III HANDPIECES TO PERFORM TMR; HOWEVER, NO LASER ENERGY WAS SEEN OR FELT COMING OUT OF EITHER HANDPIECE. ADDITIONAL INFORMATION PROVIDED BY THE CV NURSE MANAGER INDICATES THAT SHE ATTEMPTED TO USE THE TEST PROBE PRIOR TO THE PROCEDURE. A POPPING SOUND WAS HEARD BUT NO MOVEMENT WAS SEEN IN THE TEST WATER. THE CRYOLIFE REPRESENTATIVE FOR THIS HOSPITAL EVALUATED THE TEST PROBE AND CONFIRMED THAT NO LASER OUTPUT WAS SEEN (VERIFIED AFTER THE SURGERY). A PRELIMINARY EVALUATION PROVIDED BY FIELD SERVICES INDICATES THAT THE TMR CONSOLE MAY HAVE MALFUNCTION DUE TO A CRACKED BLAST SHIELD. FIELD SERVICES PERFORMED SERVICE ON THE HOSPITAL'S TMR 2000 CONSOLE SERIAL (B)(4). THIS EVALUATION DETERMINED THAT THE CONSOLE WAS FUNCTIONING PROPERLY. THE TEST FIBER WAS TESTED AND WAS FUNCTIONED AS INTENDED. THE CALIBRATION SETTINGS WERE VERIFIED TO BE CORRECT AND IT WAS DETERMINED THAT THE CONSOLE WAS OPERATING ACCORDING TO ALL FACTORY SPECIFICATIONS. THE HANDPIECES WERE RETURNED TO CRYOLIFE FOR EVALUATION. THE HANDPIECES WERE VISUALLY INSPECTED FOR DAMAGE AND WERE FURTHER EVALUATED USING A HENE LASER. IN ADDITION, BOTH HANDPIECES WERE TESTED WITH A FULLY OPERATIONAL TMR 2000 CONSOLE. HANDPIECE TA-03800-04 HAD EVIDENCE OF MISUSE. THE SHEATH COVERING THE MULTIFILAMENT FIBER SHOWED EVIDENCE OF DAMAGE. IT APPEARS THE FIBER MAY HAVE BEEN CLIPPED. WHEN THE HANDPIECE WAS PLUGGED INTO THE HENE LASER THERE WAS NOT DAMAGE TO THE MULTIFILAMENT FIBER AT THIS LOCATION; HOWEVER, THERE WAS DAMAGE APPROXIMATELY 3 MM FROM THE COUPLER. THE HANDPIECE WAS TESTED WITH A FULLY FUNCTIONAL TMR 200 CONSOLE. THE HANDPIECE WAS DELIVERING LASER ENERGY BUT WAS SPARKING AT THE AREA OF MULTIFILAMENT FIBER DAMAGE. THE INSTRUCTIONS FOR USE CURRENTLY PROVIDE INSTRUCTIONS FOR PROPER OPTICAL FIBER HANDLING. AT THE TIME THE REPORT WAS RECEIVED, CARDIOGENESIS DID NOT BELIEVE THE EVENT MET THE REPORTING REQUIREMENTS OF 21 CFR 803. THE EVENT DID NOT INVOLVE INJURY TO THE PATIENT, USER, OR ANY OTHER INDIVIDUAL. FURTHERMORE, THE EVENT WAS CONSIDERED TO BE OF A NATURE SUCH THAT A RECURRENCE COULD NOT REASONABLY BE EXPECTED TO CAUSE INJURY OR DEATH BECAUSE THE MALFUNCTION WAS CONFINED TO THE END OF THE FIBER WHICH DOES NOT CONTACT THE PATIENT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE SURGEON ATTEMPTED TO USE TWO SOLOGRIP III HANDPIECES TO PERFORM TMR; HOWEVER, NO LASER ENERGY WAS SEEN OR FELT COMING OUT OF EITHER HANDPIECE. ADDITIONAL INFORMATION PROVIDED BY THE CV NURSE MANAGER INDICATES THAT SHE ATTEMPTED TO USE THE TEST PROBE PRIOR TO THE PROCEDURE. A POPPING SOUND WAS HEARD BUT NO MOVEMENT WAS SEEN IN THE TEST WATER. THE CRYOLIFE REPRESENTATIVE FOR THIS HOSPITAL EVALUATED THE TEST PROBE AND CONFIRMED THAT NO LASER OUTPUT WAS SEEN (VERIFIED AFTER THE SURGERY). A PRELIMINARY EVALUATION PROVIDED BY FIELD SERVICES INDICATES THAT THE TMR CONSOLE MAY HAVE MALFUNCTION DUE TO A CRACKED BLAST SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265003 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL LASER REVASCULARIZATION MNO CARDIOGENESIS CORPORATION HP-SG3 TA-03800

    Patients

    Seq Age Sex Outcome Treatment
    1