BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 6149068 · Received December 6, 2016

    Report

    Report Number
    2937094-2016-01185
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Date of Event
    November 23, 2016
    Report Date
    November 23, 2016
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE IN THE FIELD WAS PERFORMED ON DECEMBER 20, 2016. THE REPLACED LPS AND Q-SWITCH DRIVER WERE RECEIVED AT THE MANUFACTURER ON SEPTEMBER 26, 2017.

    Additional Manufacturer Narrative · 1

    AS PREVIOUSLY REPORTED. SERVICE IN THE FIELD WAS PERFORMED ON DECEMBER 20, 2016. THE REPLACED LPS AND Q-SWITCH DRIVER WERE RECEIVED AT THE MANUFACTURER ON SEPTEMBER 26, 2017. THE LPS HAS BEEN DISPOSITION TO BE SCRAPPED ONCE THE FAILURE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    SYSTEM ANALYSIS / SERVICE REPAIR PERFORMED ON DECEMBER 20, 2016: THE REPORTED PROBLEM OF "POWER AND COMMUNICATIONS ISSUE" WAS CONFIRMED. REPLACED Q-SWITCH DRIVER AND CABLE, LASER POWER SUPPLY, ADDED WATER AND CLEANED FIBER PORT. RF POWER, WATER FLOW AND DETECTORS WERE SET. THE SYSTEM WAS TESTED AND VERIFIED TO MEET MANUFACTURER'S SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF A PROSTATE PROCEDURE "THE SYSTEM TURNED INTO WAITING MODE". ADDITIONAL INFORMATION WAS NOT REPORTED. NO COMPLICATION TO PATIENT WAS REPORTED. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800313 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0210R

    Patients

    Seq Age Sex Outcome Treatment
    1