BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGREENLIGHT HPS FIBER OPTIC

    MDR report key: 2982304 · Received February 25, 2013

    Report

    Report Number
    2937094-2013-00274
    Event Type
    Injury
    Date Received
    February 25, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 12, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE FIBER CAP HAD DETACHED INSIDE THE PATIENT AT 16,271 JOULES. THE PHYSICIAN WAS ABLE TO RETRIEVE THE FIBER CAP WITH GRASPERS. THERE WAS NO INDICATION OR REPORT OF ANY PART OF THE DEVICE REMAINING INSIDE THE PATIENT. A SECOND FIBER WAS USED TO COMPLETE THE CASE. NO INJURY TO PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79377 AGREENLIGHT HPS FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 242H

    Patients

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