BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLARGEN III HANDPIECE

    MDR report key: 5093522 · Received September 22, 2015

    Report

    Report Number
    1063481-2015-00229
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    August 25, 2015
    Report Date
    August 25, 2015
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MNO
    UDI-DI
    00877234000102
    PMA / PMN Number
    P970029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, "CIRCULATOR WAS GETTING THE HAND PIECE READY FOR USE YET IT WAS NOT WORKING PROPERLY." THE HOSPITAL PROVIDED INFORMATION WHICH STATED "THE LASER WOULD NOT PASS THE CALIBRATION PROCESS ON FOUR DIFFERENT TRIES." THE PROCEDURE WAS DELAYED 20 MINUTES AS ANOTHER HANDPIECE WAS OBTAINED AND USED WITHOUT ANY FURTHER ISSUES. ADDITIONAL INFORMATION INDICATED "[HANDPIECE TA-04070] DID NOT PASS LASER OUTPUT TEXT [TEST] X4 TRIES - ADDED APPROXIMATELY 20 MINS [MINUTES] TO PROCEDURE - NURSE HAD TO LEAVE ROOM TO GET ANOTHER LASER FIBER [HANDPIECE]" AND "THE LASER WOULD NOT PASS THE CALIBRATION PROCESS ON FOUR DIFFERENT TRIES." THE MANUFACTURING RECORDS FOR LOT TA-04070 WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. THE LOT PASSED FUNCTIONAL TESTING AND MET CRYOLIFE RELEASE SPECIFICATIONS. THE HANDPIECE WAS RETURNED AND EVALUATED. NO DAMAGE WAS NOTED. THE HANDPIECE WAS CONNECTED TO THE HELIUM-NEON (HENE) LASER TO TEST FUNCTIONALITY AND EFFECTIVELY DELIVERED LASER. THE HANDPIECE WAS TESTED AT ITS CALIBRATION OF 43%, AS WELL AS 49% AND 50% NUMEROUS TIMES AND FUNCTIONED PROPERLY. THE HANDPIECE WAS CONNECTED TO A SOLARGEN 2100S CONSOLE AND WAS TESTED, DELIVERING LASER BURSTS ONTO BLACK LASER ALIGNMENT PAPER. IT FUNCTIONED WITH NO DEFECTS NOTED. A ROOT CAUSE COULD NOT BE DETERMINED AND THE COMPLAINT COULD NOT BE CONFIRMED AS THE HANDPIECE EFFECTIVELY DELIVERED LASER ENERGY.

    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, "CIRCULATOR WAS GETTING THE HAND PIECE READY FOR USE YET IT WAS NOT WORKING PROPERLY." THE HOSPITAL PROVIDED INFORMATION WHICH STATED "THE LASER WOULD NOT PASS THE CALIBRATION PROCESS ON FOUR DIFFERENT TRIES." THE PROCEDURE WAS DELAYED 20 MINUTES AS ANOTHER HANDPIECE WAS OBTAINED AND USED WITHOUT ANY FURTHER ISSUES.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, "CIRCULATOR WAS GETTING THE HAND PIECE READY FOR USE YET IT WAS NOT WORKING PROPERLY." THE HOSPITAL PROVIDED INFORMATION WHICH STATED "THE LASER WOULD NOT PASS THE CALIBRATION PROCESS ON FOUR DIFFERENT TRIES." THE PROCEDURE WAS DELAYED 20 MINUTES AS ANOTHER HANDPIECE WAS OBTAINED AND USED WITHOUT ANY FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626986 SOLARGEN III HANDPIECE TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE MNO CRYOLIFE, INC. HP-SG3 TA-04070 00877234000102

    Patients

    Seq Age Sex Outcome Treatment
    1