BEUDAMED
    FDA Adverse Event Summary report: N

    SOLOGRIP III

    MDR report key: 2705543 · Received August 20, 2012

    Report

    Report Number
    2950727-2012-00006
    Date Received
    August 20, 2012
    Report Date
    September 12, 2012
    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

    A MANUFACTURING RECORDS REVIEW WAS PERFORMED TO DETERMINE IF THERE WERE ISSUES DURING MANUFACTURING THAT COULD BE ATTRIBUTED TO THE REPORTED EVENT. THERE WERE NO ISSUES DURING MANUFACTURING NOTED IN THE DEVICE HISTORY RECORD. UPON EVALUATION OF THE HANDPIECE, THE FIBER WITHIN THE HANDPIECE WAS FOUND TO BE CHARRED. ADDITIONALLY, THE FIBER WAS FOUND TO BE SEVERED. 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. CARDIOGENESIS CORPORATION IS IMPLEMENTING CHANGES TO ENSURE THERE ARE CLEAR PRECAUTIONS AGAINST BENDING THE FIBER OR THE WHITE TUBING AT A SHARP ANGLE OR OTHERWISE IMPEDING MOVEMENT OF THE FIBER.

    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 SOLOGRIP III HANDPIECE MALFUNCTIONED DURING USE AND EMITTED SPARKS DURING MOVEMENT OF THE THUMBSLIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLOGRIP III TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE MNO CARDIOGENESIS CORPORATION 705-37020 TA-03792

    Patients

    Seq Age Sex Outcome Treatment
    1