BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 2199301 · Received August 4, 2011

    Report

    Report Number
    2937094-2011-01610
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    AMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN AMERICAN MEDICAL SYSTEMS FIELD SVC ENGINEER (FSE) DETERMINED THAT THE RESONATOR (SERIAL # (B)(4)) HAD LOW POWER. THE FSE REPLACED THE RESONATOR ON (B)(6) 2011. THE RESONATOR WAS RETURNED TO AMERICAN MEDICAL SYSTEMS ON (B)(6) 2011. A FAILURE ANALYSIS, CONDUCTED BY AN AMERICAN MEDICAL SYSTEMS QUALITY ENGINEER, DISCLOSED THAT THE RESONATOR DID EXHIBIT LOW POWER. THE LOW POWER ISSUE WAS DUE TO DAMAGED OPTICAL COMPONENTS (LBO, PMUX AND DIODE MODULE). THERE WAS NO MECHANICAL/ELECTRICAL RISK AND/OR HAZARD ASSOCIATED WITH THE REPORTED ERROR MESSAGE CODES AS THE LASER SYSTEM SOFTWARE WILL NOT ALLOW THE USER ACCESS TO THE OPERATIONAL MODES. THERE WAS, HOWEVER; A RISK TO THE PT AS THE LASER SYSTEM COULD NOT BE USED TO COMPLETE THE PROCEDURE AND THE CASE WAS ABORTED. THE CUSTOMER DID INDICATE THERE WAS NO PT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011 DURING THE PROCEDURE ERROR MESSAGE CODE 171 (UNDER POWER) OCCURRED AT 8,000 JOULES. PER THE CUSTOMER, ERROR MESSAGE CODE 171 WAS CLEARED AND THEN OCCURRED AGAIN AT 10,000 JOULES. THE CUSTOMER REPORTED ERROR MESSAGE CODE 171 WAS ABLE TO BE CLEARED BUT THEN ERROR MESSAGE CODE 152 (LBO TEMP OUT OF RANGE) OCCURRED. PER THE CUSTOMER, THE PROCEDURE WAS ABORTED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT HPS LASER SYSTEM LASER SURGICAL INSTRUMENT GEX AMS, INNOVATION CENTER - SILICON VALLEY 0010-0070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1