BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 4646206 · Received March 31, 2015

    Report

    Report Number
    2937094-2015-00340
    Event Type
    Malfunction
    Date Received
    March 31, 2015
    Date of Event
    March 6, 2015
    Report Date
    March 6, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER ANESTHESIA HAD BEEN ADMINISTERED TO THE PATIENT AND PRIOR TO BEGINNING THE SURGERY, THE LASER SYSTEM DISPLAYED ERROR CODES 821, 235, 302.13 AND 202.11. THE PROCEDURE WAS RESCHEDULED. PATIENT OUTCOME: "OK" - THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212657 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0210

    Patients

    Seq Age Sex Outcome Treatment
    1