BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 11419062 · Received March 5, 2021

    Report

    Report Number
    2937094-2021-00210
    Event Type
    Malfunction
    Date Received
    March 5, 2021
    Date of Event
    February 11, 2021
    Report Date
    June 15, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    00878953005508
    PMA / PMN Number
    K092735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT A Q-SWITCH ELECTRICAL OVERSTRESS CONTRIBUTED TO THE DEVICE DISPLAYS 200 (LASER POWER SUPPLY) AND 100 (RESONATOR) ERROR MESSAGES. THE Q-SWITCH DRIVER FAILED FUNCTIONAL TESTING. FAULTS WITH THE Q-SWITCH DRIVER CAN GENERATE ERROR CODES. THE Q-SWITCH DRIVER CANNOT BE REPAIRED. IT CAN ONLY BE REPLACED. PER SERVICE REPORT PERFORMED ON SITE, THE CONSOLE PASSED FUNCTIONAL TESTING AFTER REPLACEMENT OF THE Q-SWITCH. THE REPORTED EVENT IS CONFIRMED BASED SERVICES REPORT AND ANALYSIS OF THE RETURNED Q-SWITCH. THE REVIEW FROM THE PRODUCT RECORD REVIEW CONFIRMED THAT THE CONSOLE MET SPECIFICATION PRIOR TO RELEASE AND THERE WAS NO PATIENT HARM DUE TO THE REPORTED EVENT. THERE WAS NO INFORMATION TO REASONABLY SUGGEST THAT THE REPORTED ERROR CODES DUE TO Q-SWITCH ELECTRICAL OVERSTRESS COULD POTENTIALLY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO REOCCUR. DEVICE HISTORY RECORD (DHR): A REVIEW OF THE DHR CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. DEVICE TECHNICAL ANALYSIS: THE CONSOLE WAS SERVICED BY A FIELD SERVICE ENGINEER (FSE) ONSITE. THE FSE REPLACED THE CONSOLE Q-SWITCH (QSW). THE CONSOLE WAS FUNCTIONALLY TESTED, AND THE SYSTEM MET MANUFACTURER SPECIFICATION. THE QSW WAS RETURNED FOR ANALYSIS TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. VISUAL INSPECTION CONFIRMED THAT THE QSW WAS IN OVERALL GOOD PHYSICAL CONDITION. DURING QSW DRIVER FUNCTIONAL TESTING, THE NOISE ON STATUS LINE, OUTPUT AND ADJUSTMENT, STATUS LINES CORRECT, AND CORRECT GATE MODEM FUNCTIONS DID NOT WORK. LABELING REVIEW: REVIEW OF THE COMPLAINT INFORMATION AND THE DEVICE INSTRUCTION FOR USE MANUAL DID NOT REVEAL ANY EVIDENCE OF DEVICE OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. INVESTIGATION CONCLUSION: BASED ON ANALYSIS RESULTS, A CONCLUSION CODE OF CAUSE TRACED TO COMPONENT FAILURE IS ASSIGNED TO THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE CONSOLE Q-SWITCH CONTRIBUTED TO THE REPORTED ERROR CODE 100 AND 200 AS THE CONSOLE PASSED FUNCTIONAL TESTING AFTER REPLACEMENT OF THE Q-SWITCH. THE REPORTED EVENT IS CONFIRMED. THE REVIEW FROM THE PRODUCT RECORD REVIEW CONFIRMED THAT THE CONSOLE MET SPECIFICATION PRIOR TO RELEASE AND THERE WAS NO PATIENT HARM DUE TO THE REPORTED EVENT. THERE WAS NO INFORMATION TO REASONABLY SUGGEST THAT THE REPORTED ERROR CODES LIKELY DUE TO Q-SWITCH ISSUE COULD POTENTIALLY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO REOCCUR. DEVICE HISTORY RECORD (DHR): A REVIEW OF THE DHR CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. DEVICE TECHNICAL ANALYSIS: THE CONSOLE AND/OR CONSOLE PARTS WERE NOT RETURNED FOR ANALYSIS; THEREFORE, VISUAL AND FUNCTIONAL ANALYSIS CANNOT BE PERFORMED. HOWEVER, THE CONSOLE WAS SERVICED BY A FIELD SERVICE ENGINEER (FSE) ONSITE. THE FSE REPLACED THE CONSOLE Q-SWITCH. THE CONSOLE WAS FUNCTIONALLY TESTED, AND THE SYSTEM MET MANUFACTURER SPECIFICATION. LABELING REVIEW: REVIEW OF THE COMPLAINT INFORMATION AND THE DEVICE INSTRUCTION FOR USE MANUAL DID NOT REVEAL ANY EVIDENCE OF DEVICE OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. INVESTIGATION CONCLUSION: BASED ON ANALYSIS RESULTS, A CONCLUSION CODE OF CAUSE TRACED TO COMPONENT FAILURE IS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PHOTOSELECTIVE VAPORIZATION PROCEDURE OF THE PROSTATE, ERROR CODES 235, 102.9 AND 202.11 APPEARED AFTER 90,000 JOULES OF USE. THE CONSOLE WAS SHUT DOWN AND REBOOTED; HOWEVER, THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PHOTOSELECTIVE VAPORIZATION PROCEDURE OF THE PROSTATE, ERROR CODES 235, 102.9 AND 202.11 APPEARED AFTER 90,000 JOULES OF USE. THE CONSOLE WAS SHUT DOWN AND REBOOTED; HOWEVER, THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PHOTOSELECTIVE VAPORIZATION PROCEDURE OF THE PROSTATE, ERROR CODES 235, 102.9 AND 202.11 APPEARED AFTER 90,000 JOULES OF USE. THE CONSOLE WAS SHUT DOWN AND REBOOTED; HOWEVER, THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317604 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 0010-0210 XPS50230 00878953005508

    Patients

    Seq Age Sex Outcome Treatment
    1