BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLARGEN 2100S CONSOLE

    MDR report key: 5080239 · Received September 16, 2015

    Report

    Report Number
    1063481-2015-00228
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    August 27, 2015
    Report Date
    August 27, 2015
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MNO
    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, "SURGEON WAS USING THE HAND PIECE ON THE PATIENT WHEN THE OR LIGHT BOOM WENT OUT. THEN THE SOLARGEN LOST POWER. THE LIGHTS CAME BACK ON AND THEY TRIED TO PLUG THE LASER INTO ANOTHER OUTLET YET THE LASER STILL WOULD NOT WORK." THE CASE WAS DELAYED. THE SOLARGEN CONSOLE WAS RETURNED TO CRYOLIFE IN ITS REUSABLE CONTAINER AND UNPACKED ON (B)(4) 2015 FOR EVALUATION. AN "OUT OF SERVICE" TAG WAS PLACED ON THE LASER BY THE HOSPITAL. THE CONSOLE WAS OPENED AND THE LASER CAVITY WAS INSPECTED. THE OPTIC WAS VISIBLY DAMAGED. THE REST OF THE LASER CAVITY DID NOT EXHIBIT ANY SIGNS OF DAMAGE. THE CONSOLE WAS CONNECTED TO POWER TO TEST BASIC FUNCTIONALITY AND TURNED ON WITHOUT ANY ERROR CODES. DUE TO THE DAMAGED OPTIC, FURTHER FUNCTIONALITY WAS NOT TESTED. THE HANDPIECES WHICH WERE USED DURING THE PROCEDURE WERE ALSO RETURNED FOR EVALUATION (SOLOGRIP III HANDPIECES, LOT NUMBERS TA-04071-01 AND TA-04047-87). THE HOSPITAL DID NOT NOTE ANYTHING SPECIFIC ON THE HAND PIECES, YET THEY WERE USING THEM AT THE TIME OF THE INCIDENT. THE HANDPIECES WERE VISUALLY INSPECTED AND NO DAMAGE WAS NOTED TO EITHER HANDPIECE. THE HANDPIECES WERE CONNECTED TO A HENE [HELIUM-NEON] LASER TO TEST OUTPUT. BOTH HANDPIECES EFFECTIVELY DELIVERED LASER AND NO DAMAGE WAS NOTED. THE THUMB SLIDE MECHANISMS ON BOTH HANDPIECES WERE FUNCTIONAL AND THE FIBERS RETRACTED WITHOUT PROBLEM. THE MANUFACTURING RECORDS FOR SOLARGEN CONSOLE SERIAL NUMBER (B)(4) AND SOLOGRIP III HANDPIECE LOT NUMBERS TA-04071-01 AND TA-04047-87 WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. A REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED. ON (B)(4) 2015, CRYOLIFE WAS NOTIFIED THAT THE LASER HAD TRIPPED ITS INTERNAL CIRCUIT BREAKER. AS NO REPLACEMENT PARTS WERE AVAILABLE, THE CUSTOMER WAS SENT A LOANER LASER WHICH WAS INSTALLED ON (B)(6) 2015. CONSOLE (B)(4) WAS RETURNED TO CRYOLIFE FOR SERVICE. PREVIOUS SERVICE REPORTS NOTE THAT LASER (B)(4) HAD BEEN SERVICED ON THE RECOMMENDED PREVENTIVE MAINTENANCE (PM) SCHEDULE. THE ROOT CAUSE IS THE OPTICAL CAVITY (OC) OPTIC FAILED, WHICH CAUSED THE LASER TO RAMP UP POWER TO COMPENSATE FOR THE DEFICIENCY; THE BUILT-IN SAFETY FUNCTIONS TRIPPED THE CIRCUIT BREAKER AS THEY WERE DESIGNED TO DO. THE OC OPTIC WAS REPLACED AND CLEANED, AND THE OPTICAL CAVITY RESONATOR ASSEMBLY WAS ALIGNED FOR MAXIMUM EFFICIENCY. THE ROOT CAUSE IS THE OPTICAL CAVITY (OC) OPTIC FAILED, WHICH CAUSED THE LASER TO RAMP UP POWER TO COMPENSATE FOR THE DEFICIENCY; THE BUILT-IN SAFETY FUNCTIONS TRIPPED THE CIRCUIT BREAKER AS THEY WERE DESIGNED TO DO. THE OC OPTIC WAS REPLACED AND CLEANED, AND THE OPTICAL CAVITY RESONATOR ASSEMBLY WAS ALIGNED FOR MAXIMUM EFFICIENCY. NO ISSUES WERE NOTED WITH THE TWO SOLOGRIP III HANDPIECES WHICH WERE USED DURING THE PROCEDURE. THE IFU PROVIDES THE FOLLOWING INSTRUCTIONS: "MAINS POWER QUALITY SHOULD BE THAT OF A TYPICAL HOSPITAL ENVIRONMENT," "POWER REQUIREMENT FOR THE 115 VOLT CONFIGURATION IS A 115 ± 10% VAC, 50-60 HZ, SINGLE-PHASE DEDICATED OUTLET RATED AT 15 AMPS," "A DEDICATED OUTLET IS REQUIRED FOR THE PROPER OPERATION OF THE LASER CONSOLE. DO NOT PLUG THE LASER CONSOLE INTO A POWER STRIP," AND "FOR MAJOR MALFUNCTIONS, (B)(4).

    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, "SURGEON WAS USING THE HAND PIECE ON THE PATIENT WHEN THE OR LIGHT BOOM WENT OUT. THEN THE SOLARGEN LOST POWER. THE LIGHTS CAME BACK ON AND THEY TRIED TO PLUG THE LASER INTO ANOTHER OUTLET YET THE LASER STILL WOULD NOT WORK." THE CASE WAS DELAYED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, "SURGEON WAS USING THE HAND PIECE ON THE PATIENT WHEN THE O.R. LIGHT BOOM WENT OUT. THEN THE SOLARGEN LOST POWER. THE LIGHTS CAME BACK ON AND THEY TRIED TO PLUG THE LASER INTO ANOTHER OUTLET YET THE LASER STILL WOULD NOT WORK." THE CASE WAS DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614010 SOLARGEN 2100S CONSOLE TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE MNO CRYOLIFE, INC. LSR-SG2100S

    Patients

    Seq Age Sex Outcome Treatment
    1