BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AURYON LASER SYSTEM 100-120 VAC

    MDR report key: 12688386 · Received October 25, 2021

    Report

    Report Number
    1319211-2021-10018
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    September 29, 2021
    Report Date
    December 13, 2021
    Manufacturer
    EXIMO MEDICAL LTD.
    Product Code
    MCW
    PMA / PMN Number
    K181642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE AURYON UNIT WAS SERVICED IN THE FIELD BY ANGIODYNAMICS' CONTRACTED THIRD PARTY REPAIR SERVICE. DURING FUNCTIONAL TESTING, THE UNIT FAILED FUNCTIONAL TESTING DUE TO LASER FIRING ISSUE DURING COUNT DOWN. THE UNIT WAS REMOVED FROM SERVICE, AND RETURNED TO THE ANGIODYNAMICS' SERVICE CENTER FOR EVALUATION. UNIT ARRIVED AT QBY SERVICE CENTER AND MULTIPLE FUNCTIONAL TESTS PERFORMED AND LASER SYSTEM FAULT FIRING ISSUE WAS CONFIRMED. EVALUATION ALSO PERFORMED BY LASER SYSTEM COMPONENT SUPPLIER LUMIBIRD. ROOT CAUSE OF THE PREMATURE LASING AND THE LAMP VOLTAGE FAULTS WAS DUE TO DAMAGED I/O CABLE; ALSO OBSERVED THAT FAILURE ONLY OCCURS WHEN LAMP VOLTAGE FAULT PRESENT. REPLACED I/O CABLE AND ENSURED FULLY CONNECTED AND THEN RAN THE LASER SYSTEM - NO LASER OUTPUT (I.E. NO PREMATURE LASING) ON STARTUP, NO LAMP VOLTAGE FAULTS. THE ROOT CAUSE OF THE I/O CABLE DAMAGE IS LIKELY RELATED TO HANDLING DAMAGE BUT SPECIFIC ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED. IT WAS ALSO OBSERVED THAT REAR PANEL DID NOT HAVE ANY GROMMET MATERIAL ON THE SHARP EDGE; INSTALLED THE GROMMET MATERIAL ON THE BACK PANEL TO PROTECT THE WIRES FROM RUBBING AGAINST THE METAL CAUSING WEAR. UPON COMPLETION OF ALL REPAIRS/UPGRADES, THE UNIT WAS INSPECTED FOR ANY WEAR AND CHECKED POWER BOX TO ENSURE CONNECTORS ARE HOT GLUED. THE UNIT WAS TESTED PER FUNCTIONAL TEST AND ELECTRICAL SAFETY TEST PROCESSES; UNIT MEETS ALL ACCEPTABLE CRITERIA. A REVIEW OF THE DEVICE HISTORY RECORDS (SERVICE ORDER HISTORY) WAS PERFORMED FOR THE REPORTED SERIAL NUMBER EXL039 FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE SERVICE ORDER HISTORY REVIEW CONFIRMED THAT THE UNIT MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATION PRIOR TO DISTRIBUTION. LABELING REVIEW: THE USER MANUAL, WHICH IS SUPPLIED TO THE USER WITH THIS UNIT STATES: SAFETY PRECAUTIONS IN ANY EVENT OF AN INTERNAL FAULT IN THE LASER SYSTEM, TURN OFF THE LASER SYSTEM AND CALL AN EXIMO MEDICAL TECHNICIAN FOR FURTHER INSTRUCTIONS. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATION OF THE UNIT CONFIRMED THE REPORTED ISSUE, WHEN IN READY MODE THE SYSTEM WOULD INTERMITTENTLY DELIVER LASER PULSES WITHOUT THE FOOT PEDAL BEING PRESSED. THIS CAN ONLY OCCUR WHEN THE SYSTEM IS IN READY MODE; IN STANDBY MODE THE LASER DOES NOT RECEIVE POWER AS THE FLASHLAMPS ARE TURNED OFF, AND THE INTERNAL SHUTTER REMAINS CLOSED, PHYSICALLY BLOCKING THE OPTICAL PATH. MECHANICAL DAMAGE TO ONE OF THE INTERNAL CABLES WAS FOUND, WHICH WAS THE CAUSE OF THE ISSUE. THE CABLE INVOLVED PASSES CLOSE TO THE FRAME OF THE SYSTEM. THERE WAS DAMAGE TO THE CABLE JACKET NOTED IN THE AREA NEAR WHERE THE CABLE PASSES BY THE FRAME. BENEATH THIS AREA OF DAMAGE TO THE CABLE JACKET, THE INDIVIDUAL CONDUCTORS ALSO HAD DAMAGE TO THE WIRES. UPON REVIEW OF THE HISTORY OF THIS LASER SYSTEM SERIAL NUMBER, IT WAS IDENTIFIED THAT THE UNIT HAD SUFFERED SIGNIFICANT PHYSICAL SHOCK DURING TRANSPORTATION OF THE SYSTEM. IT WAS REPORTED THAT THE SHIPPING CRATE HAD DAMAGE TO ONE SIDE, AND THAT THE RUBBER BUSHINGS INTENDED TO SUPPORT THE LASER CONTROL BOX WITHIN THE SYSTEM WERE BENT OUT OF ALIGNMENT ON EACH SIDE. IT IS BELIEVED THAT THE OBSERVED CABLE DAMAGE OCCURRED FROM THIS EXTERNAL MECHANICAL SHOCK. IN CLINICAL USE, THE PHYSICIAN WILL NOT PLACE THE SYSTEM SOFTWARE IN READY MODE UNTIL THE CATHETER HAS ADVANCED OVER THE GUIDE WIRE WITHIN THE ARTERY AND IS IN FRONT OF THE LESION TO BE ABLATED. THE TYPICAL ATHERECTOMY PROCEDURE REQUIRES A FEW (UP TO 10) MINUTES OF THE DELIVERY OF LASER PULSES TO THE LESION. BECAUSE THE ISSUE WOULD RESULT IN RELATIVELY SHORT BURSTS (A FEW SECONDS) OF LOWER ENERGY LASER PULSES IN THE MIDST OF SEVERAL MINUTES OF INTENTIONAL PULSE DELIVERY, THERE WOULD NOT BE ANY MEANINGFUL IMPACT ON THE ATHERECTOMY PROCEDURE, AND IT IS UNLIKELY THE PHYSICIAN WOULD REALIZE IT HAD OCCURRED. THE ISSUE NOTED IN THIS ROUTINE SERVICE PROCEDURE WAS THE RESULT OF UNUSUAL SHIPPING DAMAGE AND IS AN ISOLATED INCIDENT. THERE HAVE BEEN NO PREVIOUS REPORTS OF LASER SYSTEM DELIVERING PULSES IN AN UNEXPECTED MANNER. THERE WAS NO PATIENT INVOLVED IN THIS REPORT, AND ALTHOUGH IT IS UNLIKELY THAT PATIENT INJURY WOULD OCCUR UNDER THIS SET OF CIRCUMSTANCES, IN AN ABUNDANCE OF CAUTION, THIS EVENT HAS BEEN FILED AS AN MDR REPORT. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2021, ROUTINE PREVENTIVE MAINTENANCE WAS PERFORMED ON (B)(6) ON LASER SERIAL # (B)(4), AT (B)(6). DURING THE MEASUREMENT OF THE LASER POWER OUTPUT, THE SERVICE TECHNICIAN NOTED THAT WHEN IN READY MODE, THE SYSTEM WOULD INTERMITTENTLY DELIVER SHORT BURSTS OF LASER PULSES LASTING 1-2 SECONDS WITHOUT THE FOOT PEDAL BEING PRESSED. THE MEASURED POWER OUTPUT DURING THESE SHORT BURSTS WAS APPROXIMATELY 18 MJ. THE MAXIMUM OUTPUT OF THE SYSTEM IN NORMAL USE IS 33.5 MJ. THE LASER UNIT WAS REMOVED FROM SERVICE AND RETURNED TO ANGIODYNAMICS (THE US DISTRIBUTOR) FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591586 AURYON LASER SYSTEM 100-120 VAC AURYON LASER SYSTEM 100-120 VAC MCW EXIMO MEDICAL LTD. EXM-2001-1100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown