BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 14031140 · Received April 6, 2022

    Report

    Report Number
    2124215-2022-09882
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    March 16, 2022
    Report Date
    May 6, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    00878953005508
    PMA / PMN Number
    K092735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BASED ON THE INFORMATION AVAILABLE, THE CAUSE THAT CONTRIBUTED TO THE REPORTED CONSOLE STOPPED WORKING CANNOT BE ESTABLISHED AS THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. DEVICE TECHNICAL ANALYSIS: THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. LABELING REVIEW: A REVIEW OF THE DEVICE INSTRUCTIONS FOR USE (IFU) WAS COMPLETED AND DID NOT REVEAL ANY EVIDENCE OF DEVICE MISUSE, OFF LABEL USE, OR FAILURE TO FOLLOW INSTRUCTIONS. INVESTIGATION CONCLUSION: BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, THE CONSOLE STOPPED WORKING TWO TIMES CAUSING TWO FIBERS TO NO LONGER WORK. THE CONSOLE WAS TURNED OFF, THE WATER LEVEL WAS CHECKED, AND THEN THE CUSTOMER WAITED FOR A WHILE. THE CONSOLE WAS THEN TURNED ON BUT THE DEVICE STOPPED WORKING A FEW MINUTES LATER. ERROR MESSAGES 211, 235, 202.2 (LASER POWER SUPPLY), AND 302 (MASTER CONTROL BOARD) WERE DISPLAYED ON THE CONSOLE SCREEN. THE PROCEDURE WAS NOT COMPLETED AND ONLY A PARTIAL PHOTOVAPORIZATION WAS DONE. THE PATIENT HAD BEEN SEDATED WHEN THE PROCEDURE WAS ABORTED. ANOTHER PROCEDURE WILL NEED TO BE SCHEDULED. THERE WERE NO COMPLICATIONS TO THE PATIENT AND HE HAS FULLY RECOVERED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN PREPARATION FOR A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, THE PATIENT WAS SEDATED. DURING THE PROCEDURE THE CONSOLE STOPPED WORKING TWO TIMES CAUSING TWO FIBERS TO NO LONGER WORK. WHEN THE DEVICE WAS TURNED ON, THE FIRST FIBER WAS NOT RECOGNIZED. THE DEVICE WAS TURNED OFF, THE WATER LEVEL WAS CHECKED, AND THEN SOME TIME WAS ALLOWED TO PASS BEFORE TURNING THE DEVICE ON AGAIN USING A SECOND FIBER. THE SECOND FIBER WAS CONFIRMED TO BE IN GOOD CONDITION AFTER UNPACKING AND PREPARATION. HOWEVER, THE DEVICE STOPPED WORKING A FEW MINUTES LATER. ERROR MESSAGES 211, 235, 202.2 (LASER POWER SUPPLY), 302 (MASTER CONTROL BOARD), 650, AND 651 WERE DISPLAYED ON THE CONSOLE SCREEN. IT WAS NOTED THAT THE FIBER WAS NOT BURIED IN TISSUE DURING USE, AND THE METAL CAP WAS NOT LOOSE/ROTATING. THE PROCEDURE WAS NOT COMPLETE AND ONLY A PARTIAL PHOTOVAPORIZATION WAS DONE. THE PROCEDURE WAS THEN RESCHEDULED. IT WAS NOTED THAT THE PATIENT WAS ADMITTED BEYOND THE STANDARD OF CARE, THE DEVICE/PROCEDURE DID NOT CONTRIBUTE TO ANY PATIENT COMPLICATIONS, AND THE PATIENT HAS FULLY RECOVERED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2340740 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 0010-0210 00878953005508

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown