BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 2990348 · Received March 5, 2013

    Report

    Report Number
    2950727-2013-00001
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 27, 2013
    Report Date
    August 2, 2013
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, THE SURGEON WAS UNABLE TO ADVANCE THE FIBER OF THE SOLOGRIP III HANDPIECE (LOT TA-03822, SN (B)(4)). THE HANDPIECE WAS RETURNED FOR EVALUATION AND AN INVESTIGATION WAS PERFORMED. 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 FOR THE HANDPIECE. QUALITY CONTROL REVIEWED THE INCOMING INSPECTION BATCH RECORD FOR TA-03822 AND CONFIRMED THAT THE RECORD WAS COMPLETE, ACCURATE, AND FULLY APPROVED. THE HANDPIECE WAS VISUALLY INSPECTED FOR DAMAGE. THE HANDPIECE WAS NOT TESTED USING A LASER AS THE FIBER HAD CLEARLY BEEN SEVERED. THE FIBERS WERE OBSERVED TO HAVE BEEN CHARRED AND SEVERED WITHIN THE HANDPIECE. THE OBSERVED DAMAGE IS INDICATIVE OF USER MISHANDLING. 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 AND BREAKAGE OF THE FIBER BUNDLE. LASER ENERGY WOULD THEN DISPERSE AT THE AREA OF BREAKAGE, AS WAS SEEN DURING EVALUATION.

    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, AFTER 9 CHANNELS (175 PULSES) THE SURGEON NOTICED THAT THE CORD AT THE BOTTOM END OF THE SOLOGRIP III HANDPIECE WAS SEPARATED AND APPEARED BURNED. THE PATIENT'S SURGERY WAS PROLONGED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, AFTER 9 CHANNELS (175 PULSES) THE SURGEON NOTICED THAT THE CORD AT THE BOTTOM END OF THE SOLOGRIP III HANDPIECE WAS SEPARATED AND APPEARED BURNED. THE PATIENT'S SURGERY WAS PROLONGED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94203 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE MNO CARDIOGENESIS CORPORATION 705-37020 TA-03822

    Patients

    Seq Age Sex Outcome Treatment
    1 Other