BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3060183 · Received April 11, 2013

    Report

    Report Number
    2937094-2013-00433
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE CAP DETACHED AND WAS RETRIEVED AT 131741 JOULES. A SECOND FIBER WAS USED TO COMPLETE THE CASE. PATIENT OUTCOME: "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155557 GREENLIGHT HPS BPH FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 302H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other