BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 3582984 · Received January 21, 2014

    Report

    Report Number
    2950727-2014-00002
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 17, 2014
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. DEVICE NOT YET RETURNED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, A CARDIOGENESIS SOLOGRIP HANDPIECE WAS USED ON (B)(6) 2014 FOR A CABG/TMR PROCEDURE. DURING THE HANDPIECE USEAGE THE SURGEON NOTICED THAT SOMETHING SEEMED "OUT OF WHACK." WHEN FINISHING UP THE LASER HANDPIECE PART OF THE CASE, THE SURGEON NOTICED THAT THE "TIP OF THE HANDPIECE (THAT GOES INTO THE HEART-LASER PART)" WAS BENT AND BROKEN. THERE ARE LITTLE FIBERS ARE STICKING OUT OF IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48966 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL LASER REVASCULARIZATION HANDPIECE MNO CARDIOGENESIS CORPORATION HP-SG3

    Patients

    Seq Age Sex Outcome Treatment
    1