BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 3165495 · Received June 12, 2013

    Report

    Report Number
    2950727-2013-00017
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    June 7, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, THE SOLOGRIP III HANDPIECE WAS SUCCESSFULLY TESTED PRIOR TO USE. HOWEVER, WHEN THE SURGEON BEGAN THE CHANNEL MAKING PROCESS, HE NOTICED THERE WAS NO ENERGY EXITING FROM THE DISTAL END OF THE FIBER. A POPPING SOUND CAME FROM WITHIN THE HANDPIECE AND A BURNING ODOR WAS VERY EVIDENT. THE SURGEON IMMEDIATELY DISCONTINUED USE OF THE HANDPIECE. THE HANDPIECE WAS RETURNED TO CRYOLIFE FOR EVALUATION. AS SUCH, AN INVESTIGATION WAS PERFORMED. UPON EVALUATION, THE FIBERS WERE OBSERVED TO HAVE BEEN COMPLETELY SEVERED WITHIN THE HANDPIECE. THE SEVERED FIBERS APPEARED CHARRED. ADDITIONALLY, CHARRING WAS NOTED ON THE INSIDE OF THE HANDPIECE ADJACENT TO THESE FIBERS. THE PATTERN OF CHARRING ON THE PLASTIC APPEARS INDICATIVE OF BURNING THAT OCCURRED DURING BACKWARDS MOVEMENT OF THE THUMBSLIDE. ADDITIONALLY, THE WHITE STRAIN RELIEF TUBING ATTACHED TO THE HANDGRIP APPEARED TO BE BENT. A MANUFACTURING RECORDS REVIEW WAS PERFORMED TO DETERMINE IF THERE WERE ISSUES DURING MANUFACTURING THAT COULD BE ATTRIBUTED TO THE FAILURE. THERE WERE NO ISSUES DURING MANUFACTURING NOTED IN THE DEVICE HISTORY RECORD. FIBER DAMAGE CAN OCCUR WITHIN THE HANDPIECE WHEN THE MOVEMENT OF THE FIBER WITHIN THE HANDPIECE IS RESTRICTED. THE CAUSE OF THE DAMAGE OBSERVED IS MOST LIKELY FROM BENDING THE STRAIN RELIEF TUBING WHILE MOVING THE THUMBSLIDE, RESULTING IN RESTRICTION OF THE FIBER AND BUCKLING OF THE FIBER WITHIN IN THE HANDPIECE. WHEN THE LASER IS PULSED EXTREME HEAT IS PRODUCED RESULTING IN CHARRING OF THE FIBER. AS A CORRECTIVE ACTION, AN ATTENTION LABEL IS NOW ADHERED TO THE DEVICE PACKAGING. THE LABEL PROVIDES ADDITIONAL HANDLING INSTRUCTION DESIGNED TO PREVENT A RECURRENCE OF THIS TYPE OF EVENT. 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 HANDPIECE HOUSING WHICH DOES NOT CONTACT THE PATIENT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE HANDPIECE WAS NOT WORKING. THE CONSOLE WAS SUCCESSFULLY TESTED WITH THE TEST FIBER. ADDITIONALLY, THE HANDPIECE TESTED FINE IN WATER. HOWEVER, WHEN THE SURGEON BEGAN THE CHANNEL PROCESS, HE NOTICED THERE WAS NO ENERGY EXITING FROM THE DISTAL END OF THE FIBER. A POPPING SOUND WAS COMING FROM WITHIN THE HANDPIECE AND A BURNING ODOR WAS VERY EVIDENT. THE SURGEON IMMEDIATELY DISCONTINUED USE OF THE HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265467 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL LASER REVASCULARIZATION HANDPIECE MNO CARDIOGENESIS CORPORATION 705-37020

    Patients

    Seq Age Sex Outcome Treatment
    1