BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS FIBER OPTIC

    MDR report key: 2921822 · Received January 14, 2013

    Report

    Report Number
    2937094-2013-00063
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE CONCLUSION OF THE PROCEDURE AND REMOVAL, THE FIBER APPEARED TO HAVE BECOME STUCK IN TISSUE AND THE FIBER TIP BROKE OFF INSIDE OF THE PT. THE PHYSICIAN USED GRASPER TO REMOVE THE TIP FROM THE BLADDER AND WAS COMFORTABLE THAT THE TIP WAS REMOVED FROM THE PT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. IT WAS REPORTED THAT THERE WAS NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21534 GREENLIGHT HPS FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 244A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GREENLIGHT HPS LASER SYSTEM| ACCESSORIES