BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 3165585 · Received June 12, 2013

    Report

    Report Number
    2950727-2013-00023
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    September 12, 2012
    Report Date
    June 12, 2013
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 HANDPIECES, THE FIBER WITHIN BOTH HANDPIECES WAS FOUND TO BE CHARRED. 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. AS A CORRECTIVE ACTION, AN ATTENTION LABEL IS NOW ADHERED TO THE DEVICE PACKAGING. THE LABEL PROVIDES ADDITIONAL HANDLING INSTRUCTION DESIGNED TO PREVENT A RECURRENCE OF THIS TYPE OF EVENT. AT THE TIME THE REPORT WAS RECEIVED, CARDIOGENESIS DID NOT BELIEVE THE EVENT MET THE REPORTING REQUIREMENTS OF 21 CFR 803. THE EVENT DID NOT INVOLVE INJURY TO THE PATIENT, USER, OR ANY OTHER INDIVIDUAL. FURTHERMORE, THE EVENT WAS CONSIDERED TO BE OF A NATURE SUCH THAT A RECURRENCE COULD NOT REASONABLY BE EXPECTED TO CAUSE INJURY OR DEATH BECAUSE THE MALFUNCTION WAS CONFINED TO THE HANDPIECE HOUSING WHICH DOES NOT CONTACT THE PATIENT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE SURGEON HAD TROUBLE RETRACTING THE FIBER WITH THE FIRST HANDPIECE, WHICH BROKE ON TEST FIRE. THUS, HE OPENED A SECOND HANDPIECE. DURING USE, THE SECOND HANDPIECE "SHOT FIRE OUT OF THE THUMB SLIDE" AFTER A FEW CHANNELS. A THIRD HANDPIECE WAS USED TO COMPLETE THE CASE WITH NO ISSUES. NO ONE WAS INJURED. THIS REPORT IS FOR THE FIRST OF THE TWO REPORTED MALFUNCTIONS; THE SECOND REPORTED MALFUNCTION WAS PREVIOUSLY REPORTED TO THE FDA AS MDR 2950727-2012-00009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265763 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL LASER REVASCULARIZATION HANDPIECE MNO CARDIOGENESIS CORPORATION 705-37020

    Patients

    Seq Age Sex Outcome Treatment
    1