BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 3020848 · Received March 18, 2013

    Report

    Report Number
    2937094-2013-00338
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURES DESIGNATED SERVICE TECHNICIAN WAS DISPATCHED TO THE FACILITY TO EVALUATE THE LASER SYSTEM. THE SERVICE TECHNICIAN DETERMINED THAT THE ROOT CAUSE OF THE ERROR WAS DUE TO A DAMAGED INLET PORT ON THE EXTERNAL SYSTEM RESERVOIR WHICH HAS BEEN REPAIRED. THE SERVICE WAS COMPLETED AND THE LASER WAS RELEASED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE BEGINNING OF A PROCEDURE, THE LASER SYSTEM DISPLAYED ERRORS INDICATIVE OF A SYSTEM MALFUNCTION. THE LASER SYSTEM WAS REBOOTED; HOWEVER, THE ERRORS DID NOT CLEAR. THE LASER SYSTEM WAS NO LONGER ABLE TO BE UTILIZED. THE CASE WAS COMPLETED WITH ANOTHER LASER SYSTEM. NO INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112799 GREENLIGHT HPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-0070

    Patients

    Seq Age Sex Outcome Treatment
    1