BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 4838666 · Received June 11, 2015

    Report

    Report Number
    2937094-2015-00590
    Event Type
    Injury
    Date Received
    June 11, 2015
    Date of Event
    May 23, 2015
    Report Date
    May 27, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION UPDATED. DEVICE CODES ADDED. DEVICE EVALUATED BY MANUFACTURER UPDATED. EVALUATION CODES ADDED. SERVICE IN THE FIELD WAS PERFORMED ON (B)(6) 2015. THE RESONATOR, S/N (B)(4), WAS RETURNED TO MANUFACTURER ON JULY 02, 2015. PRODUCT EVALUATION SUMMARY: THE RESONATOR S/N (B)(4) WAS EVALUATED ON JULY 29, 2015. THE REPORTED ¿ERROR CODES 174, 302 AND 202¿ ISSUES COULD NOT BE REPRODUCED; HOWEVER THE CONNECTOR J310 WAS NOTED BROKEN ON RCB WHICH MIGHT HAVE BEEN DAMAGED DURING DISASSEMBLY. THE RCB WAS REPLACED. THE RESONATOR WAS OPENED AND ALL OPTICS AND PARTS WERE OBSERVED TO BE FINE. POWER CHECK AND P/I CURVE WAS DONE. THE RESONATOR WAS REALIGNED AND A NEW TEST REPORT WAS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPAIRED IN THE FIELD AND NOT RETURNED TO THE MANUFACTURER. SYSTEM ANALYSIS / SERVICE REPAIR: REPORTED ISSUE WAS ¿ERROR CODE 174, 302, 202." ¿THE RESONATOR WAS CHANGED.¿ THE SYSTEM WAS TESTED AND VERIFIED TO BE WITHIN AMS SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "ERROR MESSAGE 302, 202, 174, 171, 820, 330, 448, 213," WAS OBSERVED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED BY ALTERNATE PROCEDURE (TURP). THE PATIENT OUTCOME WAS REPORTED AS: OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383362 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0210

    Patients

    Seq Age Sex Outcome Treatment
    1 Other