BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 3967678 · Received July 30, 2014

    Report

    Report Number
    2950727-2014-00014
    Event Type
    Injury
    Date Received
    July 30, 2014
    Date of Event
    December 9, 2013
    Report Date
    December 9, 2013
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON WAS DOING A CORONARY ARTERY BYPASS GRAFTING + TRANSMYOCARDIAL LASER REVASCULARIZATION AND THE SOLOGRIP III HP MALFUNCTIONED AND "FELL APART IN THE FIELD." A NEW DEVICE WAS OPENED AND THE CASE PROCEEDED WITH NO ISSUES. ON (B)(4) 2013 ADDITIONAL INFORMATION WAS GIVEN. THE SURGERY WAS PROLONGED DUE TO THE NEED TO GET A NEW HANDPIECE; HOWEVER, THIS DID NOT CAUSE HARM TO THE PATIENT. THE HANDPIECE WAS RETURNED TO CRYOLIFE. THE SAMPLE REVIEW WAS HELD ON 01/02/2014. THE HANDPIECE WAS VISUALLY INSPECTED AND CONNECTED TO THE HENE LASER. IT WAS NOTED THAT BOTH THE MONOFILAMENT AND MULTIFILAMENT FIBERS HAD DETACHED FROM THE COUPLER. THERE MAY HAVE BEEN SOME SLIGHT CHARRING, BUT IT IS UNCLEAR WHETHER OR NOT IT WAS EXPECTED CHARRING FROM THE MANUFACTURING PROCESS. THERE WAS A PARTICLE IN THE CHANNEL THAT RUNS THROUGH THE COUPLER; OTHERWISE, THE COUPLER APPEARED NORMAL. LIGHT PASSED THROUGH THE FIBER AS NORMAL WHEN CONNECTED TO THE HENE LASER AND THERE WAS NO DAMAGE NOTED TO THE FIBER WHEN THE HANDPIECE WAS OPENED. A REVIEW OF AVAILABLE RECORDS WAS PERFORMED FOR THIS EVENT. ALL AVAILABLE RECORDS SHOW THE HANDPIECES WERE CORRECTLY ASSEMBLED FROM APPROVED COMPONENTS AND WERE INSPECTED TO SPECIFICATIONS. ALL SPECIFICATIONS IMPACTING THE INTEGRITY OF THE CRYSTALFLEX COUPLER WERE MET. THERE IS NO EVIDENCE HANDPIECE SERIAL (B)(4) WAS PRODUCED OUT OF SPECIFICATION AND WOULD HAVE ALTERATIONS LEADING TO THE DEVELOPMENT OF THIS COMPLAINT. WHILE THE ROOT CAUSE REMAINS UNKNOWN ONE POSSIBILITY COULD BE THAT THE FILAMENT DISCONNECTION FROM THE COUPLER COULD HAVE BEEN CAUSED BY EXCESSIVE FORCE BY THE HOSPITAL; SUCH AS, PULLING THE CONSOLE ACROSS THE ROOM BY THE HANDPIECE, REMOVING THE HANDPIECE FROM THE TRAY BY PULLING THE MONOFILAMENT OR MULTIFILAMENT FIBER, OR PLACING THE CONSOLE TOO FAR AWAY CAUSING TENSION DURING USE. THE INSTRUCTIONS FOR USE STATES, "SOLOGRIP III HANDPIECE CONTAINS FRAGILE FIBEROPTIC ELEMENTS. ALWAYS HANDLE THE INSTRUMENT CAREFULLY. PLACE THE LASER CONSOLE NEAR THE STERILE FIELD. POSITION THE WHITE COUPLER NEAR THE OPERATIVE SITE TO MINIMIZE TENSION ON THE OPTICAL FIBER WHEN THE HANDPIECE IS IN USE. DO NOT BEND THE OPTICAL FIBER AT SHARP ANGLES. IF BREAKS OR FRACTURES APPEAR IN THE OPTICAL FIBER, IMMEDIATELY DISCONTINUE USE AND REPLACE WITH A NEW HANDPIECE."

    Description of Event or Problem · 1

    THE SURGEON WAS DOING A CORONARY ARTERY BYPASS GRAFTING + TRANSMYOCARDIAL LASER REVASCULARIZATION AND THE SOLOGRIP III MALFUNCTIONED AND "FELL APART IN THE FIELD." A NEW DEVICE WAS OPENED AND THE CASE PROCEEDED WITH NO ISSUES. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2014 THAT THE TIME IT TOOK TO GET A NEW DEVICE DELAYED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443572 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE MNO CARDIOGENESIS CORPORATION TA-04002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other