BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 2891248 · Received December 31, 2012

    Report

    Report Number
    2950727-2012-00012
    Event Type
    Injury
    Date Received
    December 31, 2012
    Date of Event
    November 28, 2012
    Report Date
    August 6, 2013
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, THE SOLOGRIP III HANDPIECE (TA-03809-49) WAS DEFECTIVE. IN ADDITION, THE COMPLAINANT REPORTED THAT THE DEVICE BLEW APART AT THE HAND PIECE, THE FIBERS EXPLODED, AND "SPARKS FLEW." ANOTHER HANDPIECE WAS SUCCESSFULLY USED AND THE DEFECTIVE HANDPIECE WAS RETURNED FOR EVALUATION. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED FOR THIS DEVICE. THE BATCH RECORD WAS COMPLETE, ACCURATE, AND FULLY APPROVED. SIMILAR EVENTS HAVE BEEN DUE TO BENDING THE STRAIN RELIEF TUBING WHILE MOVING THE THUMBSLIDE, RESULTING IN RESTRICTION OF THE FIBER AND BUCKLING OF THE FIBER WITHIN IN THE HANDPIECE. THE HANDPIECE WAS VISUALLY INSPECTED FOR DAMAGE AND EVIDENCE OF MISHANDLING WAS NOTED. THE SHEATH PROTECTING THE MULTIFILAMENT FIBER APPEARED TO HAVE BEEN CLIPPED. IN ADDITION, THE MULTIFILAMENT FIBER WAS COMPLETELY SEVERED PROXIMAL TO THE STRAIN RELIEF. THE HANDGRIP WAS OPENED AND THE FIBERS WITHIN THE HANDGRIP WERE SEVERED AND CHARRED. CLIPPING THE MULTIFILAMENT FIBER RESULTED IN RESTRICTION OF THE MULTIFILAMENT FIBER. WHEN THIS OCCURS, THE FIBERS WITHIN THE HANDGRIP BUCKLE. CONTINUED USE OF THE HANDPIECE RESULTS IN FIBER BREAKAGE, CHARRING, AND SPARKING. IT IS NOT UNCOMMON FOR A LOUD POPPING NOISE TO OCCUR WHEN THE FIBERS BREAK DURING USE. IN RESPONSE TO COMPLAINTS OF HANDPIECE FAILURES, TSC PROJECT (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.

    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, THE SOLOGRIP III HANDPIECE WAS DEFECTIVE, IN ADDITION, THE COMPLAINANT REPORTED THAT THE DEVICE BLEW APART AT THE HAND PIECE, THE FIBERS EXPLODED AND "SPARKS FLEW." ANOTHER HANDPIECE WAS SUCCESSFULLY USED. THE DEFECTIVE HANDPIECE WAS REVIEWED. THE FIBERS PROXIMAL TO THE HANDPIECE WERE DAMAGED. IN ADDITION, THE FIBERS WITHIN THE HANDPIECE WERE DAMAGED. HOWEVER, THE HANDPIECE WAS INTACT UPON RETURN.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE SOLOGRIP III HANDPIECE WAS DEFECTIVE. IN ADDITION, THE COMPLAINANT REPORTED THAT THE DEVICE BLEW APART AT THE HAND PIECE, THE FIBERS EXPLODED AND "SPARKS FLEW". ANOTHER HANDPIECE WAS SUCCESSFULLY USED. THE DEFECTIVE HANDPIECE WAS REVIEWED. THE FIBERS PROXIMAL TO THE HANDPIECE WERE DAMAGED. IN ADDITION, THE FIBERS WITHIN THE HANDPIECE WERE DAMAGED. HOWEVER, THE HANDPIECE WAS INTACT UPON RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE MNO CARDIOGENESIS CORPORATION 705-37020 TA-03809

    Patients

    Seq Age Sex Outcome Treatment
    1 Other