BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 7243316 · Received February 6, 2018

    Report

    Report Number
    2937094-2018-00123
    Event Type
    Malfunction
    Date Received
    February 6, 2018
    Date of Event
    January 5, 2018
    Report Date
    January 8, 2018
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE XPS RESONATOR S/N (B)(4) WAS RECEIVED AT THE MANUFACTURER ON FEBRUARY 23, 2018.

    Additional Manufacturer Narrative · 1

    THE XPS RESONATOR S/N (B)(4) WAS RECEIVED AT THE MANUFACTURER ON FEBRUARY 23, 2018. PRODUCT EVALUATION: THE BOX IN WHICH THE RESONATOR WAS RETURNED WAS UNDAMAGED. A VISUAL INSPECTION OF THE RETURNED RESONATOR DID NOT SHOW ANY ISSUES. IT WAS FOUND THAT THE RESONATOR WAS FULL OF WATER AND THE RESONATOR IS A COMPLETE LOSS. THE RESONATOR ASSEMBLY WILL BE SCRAPPED. PROBABLE ROOT CAUSE: BASED ON THE ANALYSIS, THE PROBABLE ROOT CAUSE IS WATER DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE, MULTIPLE ERROR CODES WERE RECEIVED. THE PROCEDURE WAS NOT PERFORMED AND WAS RESCHEDULED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88776 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0210

    Patients

    Seq Age Sex Outcome Treatment
    1