BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED DELIVERY DEVICE, GREENLIGHT XPS

    MDR report key: 2781811 · Received October 5, 2012

    Report

    Report Number
    2937094-2012-01033
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 13, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODES FOR FIBER AND CAP ARE ASSOCIATED WITH THE DEVICE CODE FOR BREAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBER CAP DETACHED DURING THE PROSTATE PROCEDURE. IT IS UNK IF THE DEVICE WAS INSIDE THE PT AT THE TIME OF THE DETACHMENT, HOWEVER, IT APPEARS IT MAY HAVE BEEN DURING USE. THE LOCATION OF THE CAP IS UNK, HOWEVER, THERE WAS NO REPORT OF THE DEVICE REMAINING INSIDE THE PT OR THAT CAP RETRIEVAL WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. NO PT INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGLED DELIVERY DEVICE, GREENLIGHT XPS POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. 0010-2400 221A

    Patients

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