BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 3931642 · Received July 14, 2014

    Report

    Report Number
    2937094-2014-00611
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE LASER SYSTEM S/N (B)(4) WAS RETURNED TO AMS ON JULY 28, 2014. THE LASER SYSTEM S/N (B)(4) WAS EVALUATED ON JULY 29, 2014. THE LOW RESISTIVITY OF DI WATER CAUSED SHORT CIRCUIT IN THE RESONATOR DIODE STACK. CUSTOMER DECIDED TO NOT HAVE THE UNIT REPAIRED AT THIS TIME.

    Description of Event or Problem · 1

    INFORMATION AS IT WAS REPORTED TO AMS INDICATES THAT THE CUSTOMER EXPERIENCED A SYSTEM MALFUNCTION DURING A PROCEDURE. THE CUSTOMER REPORTED ERROR CODES RECEIVED (ERROR 171 & 820) . THE CASE WAS COMPLETED WITH A "ROLLERBALL" PROCEDURE. PATIENT OUTCOME: "NO PATIENT INJURY" WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410958 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0210

    Patients

    Seq Age Sex Outcome Treatment
    1