BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 9485180 · Received December 17, 2019

    Report

    Report Number
    2937094-2019-61683
    Event Type
    Injury
    Date Received
    December 17, 2019
    Date of Event
    November 25, 2019
    Report Date
    April 9, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    00878953005508
    PMA / PMN Number
    K092735
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICES MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. SERVICE ANALYSIS OF THE DEVICE REVEALED THAT THE SCREEN WAS UNABLE TO GO ONTO THE COUNTDOWN SEQUENCE. UPON CHECKING THE SOFTWARE SCREEN, IT WAS FOUND THAT THE PATHWAVE XSERIES APPLICATIONS (PXA SOFTWARE) WAS MISSING FROM THE SCREEN. THE PXA SOFTWARE WAS UPDATED AND THE LASER WAS DETERMINED TO BE WORKING; THE UNIT WAS TURNED ON/OFF SEVERAL TIMES WITHOUT ANY ISSUE. BASED ON ANALYSIS RESULTS, A CONCLUSION CODE OF CAUSE TRACED TO COMPONENT FAILURE WAS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE WITH A PATIENT INVOLVED, THE CONSOLE SCREEN FROZE. THE PROCEDURE WAS RE-SCHEDULED DUE TO THIS EVENT. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE WITH A PATIENT INVOLVED, THE CONSOLE SCREEN FROZE. THE PROCEDURE WAS RE-SCHEDULED DUE TO THIS EVENT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275662 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 0010-0210 00878953005508

    Patients

    Seq Age Sex Outcome Treatment
    1 Other