BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 5143873 · Received October 12, 2015

    Report

    Report Number
    2937094-2015-01022
    Event Type
    Malfunction
    Date Received
    October 12, 2015
    Date of Event
    September 22, 2015
    Report Date
    September 22, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM ANALYSIS/SERVICE REPAIR WAS PERFORMED ON SEPTEMBER 23, 2015. THE REPLACED RESONATOR S/N (B)(4) WAS RETURNED TO THE MANUFACTURER ON OCTOBER 19, 2015. PRODUCT EVALUATION SUMMARY: THE REPLACED RESONATOR WAS EVALUATED ON NOVEMBER 02, 2015. THE EVALUATION REVEALED DIODE VOLTAGE TO BE LOW AND 6TH BAR ON THE DIODE WAS NOTED BURNT. DIODE BASE PLATE WAS FOUND TO BE DOWN REVISION. DIODE, DIODE BASE PLACE AND DESICCANT WERE REPLACED. THE RESONATOR WAS REALIGNED AND A NEW TEST REPORT WAS COMPLETED.

    Additional Manufacturer Narrative · 1

    SYSTEM ANALYSIS/SERVICE REPAIR ON (B)(6) 2015: THE CUSTOMER'S REPORT WAS CONFIRMED AND FOUND TO BE THE RESULT OF A FAULTY RESONATOR. THE ROOT CAUSE WAS DETERMINED TO BE A SHORT STACK IN THE DIODE WITHIN THE RESONATOR. THE RESONATOR WAS REMOVED (S/N (B)(4)) AND REPLACED WITH (S/N (B)(4)) . THE SYSTEM WAS TESTED AND VERIFIED TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    UNCHECKED REPORT TYPE FROM ¿ADVERSE EVENT¿ AND CHECKED ¿PRODUCT PROBLEM.¿ UNCHECK OUTCOME ATTRIBUTED TO ADVERSE EVENT ¿OTHER SERIOUS (IMPORTANT MEDICAL EVENTS).¿ UNCHECKED TYPE OF REPORTABLE EVENT FROM ¿SERIOUS INJURY¿ AND CHECKED ¿MALFUNCTION.¿

    Additional Manufacturer Narrative · 1

    ON FOLLOW-UP #03 "DATE RECEIVED BY MANUFACTURER" WAS LEFT BLANK. THE DATE SHOULD HAVE BEEN "04/12/2016."

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE WAS DETERMINED TO BE A SHORT IN THE DIODE STACK WITHIN THE RESONATOR. THE RESONATOR WAS REMOVED (S/N (B)(4)) AND HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    ADDED TO FOLLOW UP # 3. REPORTABILITY AWARE DATE IS: 04/12/2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ERROR CODES 171, 235 & 210 WERE DISPLAYED DURING A PROCEDURE. CUSTOMER WAS ABLE TO CLEAR THE ERROR CODES BUT ERROR CODES RECURRED. THE PROCEDURE WAS COMPLETED USING A BOVIE. PATIENT OUTCOME: "NO INJURY". THERE WAS NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674326 GREENLIGHT HPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0070

    Patients

    Seq Age Sex Outcome Treatment
    1 Other