BEUDAMED
    FDA Adverse Event Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 2418378 · Received January 17, 2012

    Report

    Report Number
    2950727-2012-00003
    Date Received
    January 17, 2012
    Date of Event
    November 28, 2011
    Report Date
    August 22, 2012
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FUTHERMORE, THIS REPORT RELECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED ON LOTS POSSIBLY AVAILABLE AT THE TIME THE EVENT OCCURRED. THE MANUFACTURING REVIEW INDICATES THAT ALL LOTS WERE MANUFACTURED ACCORDING TO ALL MANUFACTURING SPECIFICATIONS. IT IS POSSIBLE THAT RESTRICTION OF THE AXIAL MOVEMENT OF THE FIBER BUNDLE DURING THUMBSLIDE RETRACTION CAUSED THE FIBER BUNDLE TO BUCKLE AND FAIL. HOWEVER, WITH THE AVAILABLE INFORMATION, NO DEFINITIVE CONCLUSIONS CAN BE MADE. CARDIOGENESIS CORPORATION IS IMPLEMENTING CHANGES TO ENSURE THERE ARE CLEAR PRECAUTIONS AGAINST BENDING THE FIBER OR THE WHITE TUBING AT A SHARP ANGLE OR OTHERWISE IMPEDING MOVEMENT OF THE FIBER.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, A BURNING SMELL WAS NOTED WHEN THE SURGEON ATTEMPTED TO USE THE FIRST HANDPIECE. IN ADDITION, THE HANDPIECE WOULD NOT CREATE CHANNELS. A SECOND HANDPIECE WAS OPENED. THE HANDPIECE WORKED INITIALLY; HOWEVER, AFTER THE FIRST 20 MINUTES THE HANDPIECE WOULD NO LONGER CREATE CHANNELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLOGRIP III HANDPIECE TMR HANDPIECE DEVICE MNO CARDIOGENESIS CORPORATION 705-37020

    Patients

    Seq Age Sex Outcome Treatment
    1