BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 5658666 · Received May 16, 2016

    Report

    Report Number
    2937094-2016-00521
    Event Type
    Injury
    Date Received
    May 16, 2016
    Date of Event
    May 12, 2016
    Report Date
    May 12, 2016
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM ANALYSIS/SERVICE REPAIR ON JUNE 16, 2016: THE REPORTED ISSUE OF ¿ERROR CODES 211, 235, 302.13, AND 202.1¿ WAS CONFIRMED. THE RESONATOR WAS REPLACED AND THE LASER WAS CALIBRATED. THE SYSTEM WAS TESTED AND VERIFIED TO MEET MANUFACTURER'S SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    SYSTEM ANALYSIS/SERVICE REPAIR IN THE FIELD WAS PERFORMED ON (B)(6) 2016. THE REPLACED RESONATOR S/N (B)(4) WAS RECEIVED AT THE MANUFACTURER ON JULY 11, 2016.

    Additional Manufacturer Narrative · 1

    SYSTEM ANALYSIS/SERVICE REPAIR IN THE FIELD WAS PERFORMED ON JUNE 16, 2016. THE REPLACED RESONATOR S/N (B)(4) WAS RECEIVED AT THE MANUFACTURER ON JULY 11, 2016. PRODUCT EVALUATION: THE RESONATOR EVALUATION WAS COMPLETED ON AUGUST 30, 2016 AND NOTED ERROR CODE 211, 235, 302.13, 202.1 AND OVER VOLTAGE WERE DUPLICATED; COULD NOT TURN ON DIODE, THIRD BAR FROM TOP WAS BURNT AND COUPLER COVER WAS STUCK. NO ISSUE NOTED WITH COUPLER ASSEMBLY. THE DIODE, COUPLER COVER AND DESICCANT WERE REPLACED. THE POWER CHECK AND P/I CURVE WAS PERFORMED. A NEW TEST REPORT WAS COMPLETED. PROBABLE ROOT CAUSE: BASED ON THE ANALYSIS REPORT, THE ROOT CAUSE WAS DETERMINED TO BE DEFECTIVE DIODE IN THE RESONATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BPH SURGICAL PROCEDURE "ERROR CODES 211, 235, 302.13, AND 202.1" WERE NOTED. THE CASE WAS COMPLETED USING AN ALTERNATE PROCEDURE (TURP). PATIENT OUTCOME: "NO INJURY" TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311160 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