BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3052904 · Received April 1, 2013

    Report

    Report Number
    2937094-2013-00438
    Event Type
    Injury
    Date Received
    April 1, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 8, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE CAP DETACHED INSIDE THE PATIENT. THE CAP WAS RETRIEVED; METHOD UNKNOWN. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131420 GREENLIGHT HPS BPH FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS NA 242H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other