BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 4397209 · Received January 8, 2015

    Report

    Report Number
    2937094-2015-00020
    Event Type
    Malfunction
    Date Received
    January 8, 2015
    Date of Event
    December 19, 2014
    Report Date
    December 24, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SERVICE IN FIELD WAS PERFORMED ON (B)(6) 2014. RESONATOR S/N (B)(4) WAS RETURNED TO AMS AND ANALYSIS PERFORMED ON (B)(6) 2015. PRODUCT EVALUATION SUMMARY: THE RESONATOR EVALUATION NOTED THAT YAG ROD WAS PUSHED FORWARD; Q-SWITCH HAD OVERHEAD TEMPERATURE. THE YAG ROD WAS ADJUSTED AND RE-TORQUED THE ROD HOUSING. Q-SWITCH, CLAMPS, HOSING AND DESICCANT WERE REPLACED. THE RESONATOR WAS RE-PEAKED AND A NEW TEST REPORT WAS COMPLETED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE CONSOLE WAS EVALUATED AND REPAIRED IN THE FIELD ON DECEMBER 25, 2014. INFORMATION EXTRACTED FROM SERVICE REPORT: ¿STEP ON THE FOOT PEDAL; ERROR '171' DISPLAY; LOG ERROR CODE '171' '251' '866'; REPLACE RESONATOR .REPLACE PM KIT AND CALIBRATION.¿ PROBABLE ROOT CAUSE: BASED ON THE RESULTS OF THE INVESTIGATION, THE PRODUCT COMPLAINT OF "ERROR 171" WAS CONFIRMED; THERE WAS A FAILURE FOUND WITH THE RESONATOR, AND THE RESONATOR WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE LASER STOPPED AND ERROR 171 (LASER UNDER POWER) DISPLAYED WHEN THE PHYSICIAN STEPPED ON FOOT PEDAL. THE PHYSICIAN CHANGED ¿SURGICAL PROCEDURE¿ TO COMPLETE THE CASE. PATIENT OUTCOME ¿FINE¿ REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17618 GREENLIGHT HPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0077

    Patients

    Seq Age Sex Outcome Treatment
    1