BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 5328550 · Received December 27, 2015

    Report

    Report Number
    2937094-2015-01249
    Event Type
    Injury
    Date Received
    December 27, 2015
    Report Date
    December 3, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF SERVICE (B)(4) 2015: SYSTEM ANALYSIS/SERVICE REPAIR: ERROR CODE #173, #866 ON LOG FILE. REPLACE RESONATOR S/N (B)(4) WITH RESONATOR (B)(4) AFTER CALIBRATION. PERFORMANCE TEST. REPORTEDLY, RESONATOR S/N (B)(4) WAS RETURNED.

    Additional Manufacturer Narrative · 1

    SYSTEM ANALYSIS/ SERVICE REPAIR WAS PERFORMED ON DECEMBER 03, 2015. THE REPLACED RESONATOR S/N (B)(4) WAS RECEIVED BY THE MANUFACTURER ON DECEMBER 29, 2015. PRODUCT EVALUATION: THE RESONATOR EVALUATION WAS COMPLETED BY FEBRUARY 25, 2016. THE EVALUATION NOTED NO PACKAGING DAMAGE ON CRATE; NO EXTERNAL DAMAGE TO THE RESONATOR; Q-SWITCH AND LAM OPTIC WAS NOTED TO HAVE BRIGHT SPOT AND COUPLER COVER WAS STUCK. THE Q-SWITCH, LAM OPTIC WITH PLATE; COUPLER COVER AND DESICCANT WERE REPLACED. THE RESONATOR POWER WAS RE-PEAKED AND A NEW TEST REPORT WAS COMPLETED. PROBABLE ROOT CAUSE: BASED ON THE ANALYSIS REPORT, THE ROOT CAUSE WAS DETERMINED TO BE Q-SWITCH, LAM OPTIC AND COUPLER COVER.

    Additional Manufacturer Narrative · 1

    SYSTEM ANALYSIS/ SERVICE REPAIR WAS PERFORMED ON DECEMBER 03, 2015. THE RESONATOR S/N (B)(4) WAS REPLACED WITH RESONATOR S/N (B)(4). THE REPLACED RESONATOR S/N (B)(4) HAS NOT BEEN RECEIVED BY THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION UPDATED; DEVICE EVALUATED BY MANUFACTURER UPDATED. SYSTEM ANALYSIS/ SERVICE REPAIR WAS PERFORMED ON DECEMBER 03, 2015. THE REPLACED RESONATOR S/N (B)(4) WAS RECEIVED BY THE MANUFACTURER ON DECEMBER 29, 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, "ERROR CODE #173 POP UP DISPLAY AFTER POWER IS TURNED ON, CANNOT CLEAR". THE PROCEDURE WAS COMPLETED BY A TURP. PATIENT OUTCOME: "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852651 GREENLIGHT HPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0077

    Patients

    Seq Age Sex Outcome Treatment
    1 Other