BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 5058468 · Received September 4, 2015

    Report

    Report Number
    2937094-2015-00885
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 12, 2015
    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). SYSTEM ANALYSIS/SERVICE REPAIR: THE LASER CONSOLE WAS RETURNED TO THE MANUFACTURER FOR FURTHER ANALYSIS. IT WAS DETERMINED THERE WAS A DAMAGED LASER CONTROL BOARD AND A SHORTED CABLE HARNESS FROM RESONATOR CONTROL BOARD TO LASER CONTROL BOARD. LASER CONTROL BOARD, CABLE ASSEMBLY AND Q-SW DRIVER WERE REPLACED. THE RESONATOR MODULE WAS REPAIRED. THE SYSTEM WAS TESTED AND VERIFIED TO MEET SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE SMOKE ISSUE WAS DETERMINED TO BE FROM AN INTERNAL CABLE ASSEMBLY THAT HAS SHORTED AND BURNT MULTIPLE WIRES, PER THE PHOTOS RECEIVED FROM THE DISTRIBUTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING THE PROCEDURE, THE SMELL OF SMOKE OCCURRED FROM THE INSIDE OF THE DEVICE AND THEN THE TOUCH PANEL DISPLAYED AN "ERROR" THE TOUCH PANEL DISPLAY HAD TURNED BLACK FINALLY. THE POWER HAD NOT TURNED OFF SO AFTER TUNING OFF THE POWER, THE PROCEDURE HAD BEEN DISCONTINUED". NO ADDITIONAL INFORMATION PROVIDED. PATIENT OUTCOME: THERE WAS NO REPORT OF HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588907 GREENLIGHT HPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0077

    Patients

    Seq Age Sex Outcome Treatment
    1