BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 3657287 · Received March 4, 2014

    Report

    Report Number
    2937094-2014-00113
    Event Type
    Injury
    Date Received
    March 4, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 10, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MASTER CONTROL BOARD (MCB) S/N (B)(4) WAS RETURNED TO AMS ON (B)(6) 2014 AND WAS SENT TO SUPPLIER. PRODUCT EVALUATION: THE MASTER CONTROL BOARD S/N (B)(4) WAS EVALUATED BY THE SUPPLIER ON (B)(6) 2014. THE REPORTED ¿ERRORS 233, 235, 210, 211 AND 202.13¿ ISSUES WERE CONFIRMED AND SYSTEM FILE FAILED AT TEST. THE SD CARD WAS NOTED MISSING. DURING TROUBLE SHOOTING U500 AND U800 WERE TOUCHED UP AND NO DEFECTS WERE NOTED BEFORE TOUCH UP. THE SD CARD WAS REPLACED AND MASTER CONTROL BOARD PASSED THE STANDARD PRODUCTION TEST. PROBABLE ROOT CAUSE: BASED ON SUPPLIER FA REPORT, THE ROOT CAUSE WAS DETERMINED TO BE THE SYSTEM FILE AND SD CARD IN THE MASTER CONTROL BOARD.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE MASTER CONTROL BOARD (MCB) S/N (B)(4) WAS RETURNED TO AMS ON (B)(6) 2014 AND WAS SENT TO SUPPLIER.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE CONSOLE WAS EVALUATED AND REPAIRED IN THE FIELD ON (B)(4) 2014. FIELD SERVICE ENGINEER CONFIRMED THE REPORTED ISSUE. ERROR 233, 235, 210, 211, 202 WERE OBSERVED DURING WARM UP. PROBABLE ROOT CAUSE: BASED ON THE FIELD SERVICE REPORT RESULTS THE ROOT CAUSE WAS DETERMINED TO BE THE LPS AND MCB.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ERROR CODES WERE OBSERVED DURING THE PROCEDURE. THE CUSTOMER WAS UNSUCCESSFUL IN GETTING THE LASER TO RESUME FUNCTION. THE PHYSICIAN COMPLETED THE PROCEDURE WITH TURP. ¿NO INJURY TO PATIENT¿ REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129779 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0210

    Patients

    Seq Age Sex Outcome Treatment
    1 Other