BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 3168396 · Received June 13, 2013

    Report

    Report Number
    2950727-2013-00038
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 28, 2013
    Report Date
    October 9, 2013
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CRYOLIFE HAS INITIATED AN INVESTIGATION AND IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION. THE RESULTS OF THE INVESTIGATION AND ANY ADDITIONAL INFORMATION OBTAINED WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, SPARKS WERE EMITTED FROM THE FIBER, APPROXIMATELY ONE FOOT FROM THE CONSOLE. NO INJURIES OCCURRED. 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. HANDPIECE TA-03826-37 WAS EVALUATED AND THE MONOFILAMENT FIBER AND THE SLEEVE WERE BROKEN. THERE WERE BREAKS IN THE FIBER WHICH RESULTED IN MELTING AND BREAKAGE OF THE SLEEVE WHEN THE LASER WAS PASSED THROUGH THE BROKEN FIBER. THERE APPEARED TO BE ABERRATIONS ON THE ACTUAL MONOFILAMENT FIBER. IT APPEARS THAT THE MONOFILAMENT FIBER BROKE RESULTING IN THE EMISSION OF ENERGY THAT CAUSES THE SHEATH TO MELT AND BREAK. HOWEVER, THE REASON FOR THE BREAK CANNOT BE DETERMINED. THE HANDPIECE RETURNED TO THE CONTRACT MANUFACTURER FOR FURTHER EVALUATION. THE CONTRACT MANUFACTURER EVALUATED THE RETURNED HANDPIECE AND THE DEVICE HISTORY RECORD FOR THE HANDPIECE DID NOT REVEAL ANY ISSUES. FOR HANDPIECE TA-03826-37, THE OUTER TUBING JACKET APPEARED TO HAVE BEEN MELTED WHERE THE BREAK IN THE FIBER OCCURRED. THE FIBER HAD MINOR VISUAL ABERRATIONS IN ADDITION TO BLACK BURN SPOTS. AFTER REVIEWING THE VISUAL SPECIFICATION FOR THE FIBER PART, THE ABERRATIONS WHICH WERE VISIBLE UNDER 10X MAGNIFICATION WOULD NOT HAVE BEEN REJECTED AT RECEIVING INSPECTION. THE UNIT WAS ALSO REVIEWED WITH MANUFACTURING PERSONNEL AND WITH THE EXCEPTION OF THE BURN SPOTS, DID NOT VISIBLY DIFFER FROM THE CURRENT PARTS IN THE MANUFACTURING AREA. IT IS UNKNOWN WHETHER THESE ANOMALIES MAY HAVE CONTRIBUTED TO THE FAILURE AND THE CONTRACT MANUFACTURER WAS UNABLE TO DETERMINE A ROOT CAUSE. THE CONTRACT MANUFACTURER CONTINUED TO STATE THAT DEVICES ARE 100% TESTED FOR BROKEN FIBERS AT BOTH THE CRYSTAL FLEX SUB ASSEMBLY AND SOLOGRIP FINAL QC INSPECTION. A BROKEN FIBER IN THE AREA WHERE THE TUBING JACKET MELTED WOULD HAVE EXHIBITED A RED GLOW UNDERNEATH THE TUBING JACKET AND WOULD HAVE BEEN REJECTED PER PROCEDURE. CORRECTED DATA: ON THE INITIAL REPORT, THE SERIAL NUMBER WAS MISREPORTED AS (B)(4). THE CORRECT SERIAL NUMBER IS (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, SPARKS WERE EMITTED FROM THE OPTICAL FIBER APPROXIMATELY ONE FOOT FROM THE CONSOLE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, SPARKS WERE EMITTED FROM THE OPTICAL FIBER APPROXIMATELY ONE FOOT FROM THE CONSOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270043 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL LASER REVASCULARIZATION HANDPIECE MNO CARDIOGENESIS CORPORATION HP-SG3 TA-03826

    Patients

    Seq Age Sex Outcome Treatment
    1