BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 3165857 · Received June 12, 2013

    Report

    Report Number
    2950727-2013-00036
    Event Type
    Injury
    Date Received
    June 12, 2013
    Date of Event
    May 21, 2013
    Report Date
    July 31, 2013
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    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

    ACCORDING TO THE REPORT, DR. (B)(6) SAID THE TIP FELT LIKE IT WAS STICKING IN THE SOLOGRIP III HAND PIECE (TA-03828-13) AND WAS NOT WORKING PROPERLY. THEY OPENED ANOTHER LASER AND REMOVED THE DEFECTIVE ONE. THEY THEN REALIZED THAT THE CORD AT THE BOTTOM OF THE HAND PIECE APPEARED BURNED. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED FOR THIS DEVICE. THE BATCH RECORD WAS COMPLETE, ACCURATE, AND FULLY APPROVED. THE HANDPIECE WAS VISUALLY INSPECTED FOR DAMAGE AND THE MULTIFILAMENT FIBER WAS FOUND TO BE COMPLETELY BROKEN NEAR THE THUMBSLIDE; IT HAD COMPLETELY SEPARATED FROM THE HANDPIECE COMPONENT. THE OBSERVED DAMAGE WAS MOST LIKELY FROM BENDING THE STRAIN RELIEF TUBING WHILE MOVING THE THUMBSLIDE, RESULTING IN RESTRICTION OF THE FIBER AT THE PROXIMAL END OF THE HANDPIECE. IN RESPONSE TO COMPLAINTS OF HANDPIECE FAILURES, (B)(4) WAS INITIATED. THE PROJECT RESULTED IN DESIGN CHANGES TO THE TMR HANDPIECES TO ELIMINATE FIBER BREAKAGE WITHIN THE MAIN BODY OF THE HANDPIECES AND OUTSIDE AND PROXIMAL TO THE MAIN BODY OF THE HANDPIECES. NO FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT THE SURGEON STATED THE TIP FELT LIKE IT WAS STICKING IN THE HAND PIECE AND WAS NOT WORKING PROPERLY. WE OPENED ANOTHER LASER AND REMOVED THE DEFECTIVE ONE. WE THEN REALIZED THAT THE CORD AT THE BOTTOM OF THE HANDPIECE APPEARED BURNED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT THE SURGEON STATED THE TIP FELT LIKE IT WAS STICKING IN THE HAND PIECE AND WAS NOT WORKING PROPERLY. WE OPENED ANOTHER LASER AND REMOVED THE DEFECTIVE ONE. WE THEN REALIZED THAT THE CORD AT THE BOTTOM OF THE HANDPIECE APPEARED BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266458 SOLOGRIP III HANDPIECE TRANSMYCARDIAL LASER REVASCULARIZATION HANDPIECE MNO CARDIOGENESIS CORPORATION HP-SG3 TA-03828

    Patients

    Seq Age Sex Outcome Treatment
    1