BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 2707338 · Received August 21, 2012

    Report

    Report Number
    2950727-2012-00007
    Event Type
    Malfunction
    Date Received
    August 21, 2012
    Date of Event
    May 2, 2012
    Report Date
    August 21, 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

    THIS EVENT WAS PREVIOUSLY SUBMITTED AS MANUFACTURER REPORT NUMBER 1604318-2012-00020; HOWEVER, THE CORRECT MANUFACTURER REPORT NUMBER IS 2950727-2012-00007. 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 FIBERS WERE OBSERVED TO HAVE BEEN DAMAGED, POSSIBLY DUE TO SHARP BENDING OF THE FIBERS. 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, FLAMES WERE EMITTED FROM THE PROXIMAL END OF THE SOLOGRIP III HANDPIECE AFTER APPROXIMATELY NINE CHANNELS WERE CREATED. NO INJURIES WERE REPORTED AND ANOTHER HANDPIECE WAS UTILIZED TO COMPLETE THE CASE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, FLAMES WERE EMITTED FROM THE PROXIMAL END OF THE SOLOGRIP III HANDPIECE AFTER CREATING APPROXIMATELY NINE CHANNELS. NO INJURIES WERE REPORTED AND ANOTHER HANDPIECE WAS UTILIZED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE MNO CARDIOGENESIS CORPORATION 705-37020 TA-03733

    Patients

    Seq Age Sex Outcome Treatment
    1