BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 5460870 · Received February 25, 2016

    Report

    Report Number
    2937094-2016-00194
    Event Type
    Malfunction
    Date Received
    February 25, 2016
    Date of Event
    February 8, 2016
    Report Date
    February 15, 2016
    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

    SYSTEM ANALYSIS/SERVICE REPAIR IN THE FIELD WAS PERFORMED ON (B)(4) 2016. THE RESONATOR S/N (B)(4) WAS RECEIVED AT THE MANUFACTURER ON (B)(4) 2016. PRODUCT EVALUATION: THE RESONATOR EVALUATION WAS COMPLETED ON MARCH 15, 2016 AND NOTED NO PACKAGING DAMAGE ON THE CRATE AND NO EXTERNAL DAMAGE ON THE RESONATOR. THE 4TH BAR ON THE DIODE WAS NOTED BURNT AND ALL OTHER OPTICS WERE NOTED TO BE FINE. THE DIODE AND DESICCANT WERE REPLACED. THE RESONATOR POWER WAS RE-PEAKED AND A NEW TEST REPORT WAS COMPLETED. PROBABLE ROOT CAUSE: BASED ON THE FA REPORT, THE ROOT CAUSE WAS DETERMINED TO BE DIODE IN THE RESONATOR.

    Additional Manufacturer Narrative · 1

    SYSTEM ANALYSIS/SERVICE REPAIR IN THE FIELD WAS PERFORMED ON FEBRUARY 13, 2016. THE RESONATOR S/N (B)(4) WAS RECEIVED AT THE MANUFACTURER ON FEBRUARY 29, 2016.

    Additional Manufacturer Narrative · 1

    SYSTEM ANALYSIS/SERVICE REPAIR BY THE DISTRIBUTOR ON FEBRUARY 13, 2016: THE REPORTED ERROR CODES 211 & 235 WERE CONFIRMED AND DETERMINED TO BE THE RESULT OF A DEFECTIVE RESONATOR. THE RESONATOR WAS REPLACED AND CALIBRATION WAS PERFORMED. THE SYSTEM WAS TESTED AND VERIFIED TO MEET SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHILE IN PREPARATION OF THE SURGERY, THE DEVICE HAD POWERED ON. AFTER POWERING ON ERROR 211, 235 WAS OBSERVED AND THEN THE LASER WOULD NOT POWER ON ANY LONGER. THE SURGERY WAS COMPLETED BY ANOTHER METHOD. PATIENT OUTCOME: THERE WAS NO REPORT OF A PATIENT OR USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116807 GREENLIGHT HPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0077

    Patients

    Seq Age Sex Outcome Treatment
    1