BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED DELIVERY DEVICE, GREENLIGHT XPS

    MDR report key: 2575690 · Received May 2, 2012

    Report

    Report Number
    2937094-2012-00412
    Event Type
    Malfunction
    Date Received
    May 2, 2012
    Date of Event
    April 4, 2012
    Report Date
    April 11, 2012
    Manufacturer
    AMS INNOVATIVE CENTER-SAN JOSE
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ¿ REFERS TO FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER; A CODE REQUEST HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SIDE-FIRING FIBER WAS NOTICED TO HAVE COMMENCED FORWARD FIRING AT 11,589 JOULES DURING PROSTATE VAPORIZATION. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. IT WAS REPORTED THAT THERE WAS NO PT INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGLED DELIVERY DEVICE, GREENLIGHT XPS SURGICAL FIBER GEX AMS INNOVATIVE CENTER-SAN JOSE 0010-2400 209A

    Patients

    Seq Age Sex Outcome Treatment
    1 GREENLIGHT XPS SURGICAL LASER SYSTEM & ACCESSORIES