BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 3243334 · Received July 23, 2013

    Report

    Report Number
    2950727-2013-00039
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 26, 2013
    Report Date
    August 6, 2013
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, TWO HANDPIECES INITIALLY FIRED BUT STOPPED WORKING AFTER A FEW CHANNELS. THERE WERE NO PATIENT INJURIES. THIS REPORT REPRESENTS THE FIRST OF THE TWO HANDPIECES. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. BOTH DEVICES WERE EVALUATED VISUALLY. THIS EVALUATION REVEALED CHARRING OF THE FIBER THAT IS USUALLY CONTAINED WITHIN THE HANDPIECE; THE CHARRING CAUSED THE FIBER TO BREAK APART AND THIS ALLOWED THE FIBER TO SLIP OUT THE BACK. THIS DAMAGE IS CONSISTENT WITH USER ERROR INVOLVING 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 BREAKAGE OF THE FIBER BUNDLE. THE SAME DAMAGE WAS SEEN IN BOTH DEVICES.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, TWO HANDPIECES INITIALLY FIRED BUT STOPPED WORKING AFTER A FEW CHANNELS. THERE WERE NO PATIENT INJURIES. THIS REPORT REPRESENTS THE FIRST OF THE TWO HANDPIECES. BOTH DEVICES WERE EVALUATED VISUALLY. THIS EVALUATION REVEALED CHARRING OF THE FIBER THAT IS USUALLY CONTAINED WITHIN THE HANDPIECE; THE CHARRING CAUSED THE FIBER TO BREAK APART AND THIS ALLOWED THE FIBER TO SLIP OUT THE BACK. THIS DAMAGE IS CONSISTENT WITH USER ERROR INVOLVING 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 BREAKAGE OF THE FIBER BUNDLE. THE SAME DAMAGE WAS SEEN IN BOTH DEVICES.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE HANDPIECE WOULD FIRE AND THEN STOP WORKING AFTER A FEW CHANNELS.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE HANDPIECE WOULD FIRE AND THEN STOP WORKING AFTER A FEW CHANNELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342751 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL LASER REVASCULARIZATION HANDPIECE MNO CARDIOGENESIS CORPORATION HP-SG3 TA-03836

    Patients

    Seq Age Sex Outcome Treatment
    1