BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 4262851 · Received November 19, 2014

    Report

    Report Number
    2950727-2014-00025
    Event Type
    Injury
    Date Received
    November 19, 2014
    Date of Event
    November 10, 2014
    Report Date
    November 10, 2014
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    THE SURGEON COMPLETED 19 CHANNELS ON THE PATIENT OF TMR AND THEN CONTINUED TO CONDUCT A CABG. LATER IN THE CASE THE SURGEON DECIDED TO ADD MORE CHANNELS AND IT WAS DISCOVERED THAT THE HANDPIECE WAS NOT FUNCTIONAL AND THE CABLE HAD SEPARATED AT THE COUPLER. THE STAFF OPENED ANOTHER HANDPIECE TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE SURGERY AND THE PATIENT HAD NO IMPACT. THE HANDPIECE WAS RETURNED TO CRYOLIFE ON 11/12/2014. THE HANDPIECE WAS VISUALLY INSPECTED. THE HANDPIECE WAS RETURNED TO CRYOLIFE IN TWO PIECES WITH THE DISCONNECTION BEING ON THE MONOFILAMENT SIDE OF THE COUPLER. THE MONOFILAMENT FIBER WAS NOT DISCONNECTED FROM THE COUPLER. CHARRING COULD BE SEEN WHERE THE FIBER BECAME DISCONNECTED AND THE PLASTIC OUTER COVERING HAD BEEN MELTED. DAMAGE NOTED DURING THE REVIEW IS CONSISTENT WITH DAMAGE CAUSED BY FIRING THE LASER WHILE THE MONOFILAMENT FIBER IS DAMAGED. IF THE FIBER BECOMES BENT OR DAMAGED AND THE LASER IS PULSED EXTREME HEAT IS PRODUCED RESULTING IN CHARRING OF THE FIBER WHICH CAN EVENTUALLY BURN THROUGH THE MONOFILAMENT FIBER. THE MANUFACTURING RECORDS FOR THE LOT NUMBER WAS REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. THE IFU STATES "IF BREAKS OR FRACTURES APPEAR IN THE OPTICAL FIBER, IMMEDIATELY DISCONTINUE USE AND REPLACE WITH A NEW HANDPIECE." ALL UNITS FROM THE LOT WERE CONSTRUCTED FROM APPROVED COMPONENTS AND MET ALL SPECIFICATIONS; THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT CRYOLIFE. THE IFU CONTAINS ADEQUATE INSTRUCTIONS AND WARNINGS FOR PROPER OPERATION OF THE DEVICE.

    Description of Event or Problem · 1

    SURGEON COMPLETED 19 CHANNELS ON THE PATIENT AND THEN CONTINUED TO CONDUCT A CABG. LATER IN THE CASE THE SURGEON DECIDED TO ADD MORE CHANNELS AND IT WAS DISCOVERED THAT THE HANDPIECE WAS NOT FUNCTIONAL AND THE CABLE HAD SEPAERATED AT THE COUPLER. THE STAFF HAD TO OPEN ANOTHER HANDPIECE TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN TE SURGERY AND THE PATIENT HAD NO IMPACT.

    Description of Event or Problem · 1

    SURGEON COMPLETED 19 CHANNELS ON THE PATIENT AND THEN CONTINUED TO CONDUCT A CABG. LATER IN THE CASE THE SURGEON DECIDED TO ADD MORE CHANNELS AND IT WAS DISCOVERED THAT THE HANDPIECE WAS NOT FUNCTIONAL AND THE CABLE HAD SEPARATED AT THE COUPLER. THE STAFF HAD TO OPEN ANOTHER HANDPIECE TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN TE SURGERY AND THE PATIENT HAD NO IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749561 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL REVASCULARIZATION MNO CARDIOGENESIS CORPORATION HP-SG3 TA-04039

    Patients

    Seq Age Sex Outcome Treatment
    1 Other