BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 3261261 · Received July 31, 2013

    Report

    Report Number
    2937094-2013-00833
    Event Type
    Injury
    Date Received
    July 31, 2013
    Date of Event
    April 1, 2012
    Report Date
    July 11, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFO IS AVAILABLE REGARDING SERIAL NUMBER OF THE LASER USED; THE DOCTOR BELIEVES IT WAS A 120W SYSTEM (HPS GREENLIGHT LASER SYSTEM).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS "COMPLETELY INCONTINENT POST OP AND NEVER RECOVERED". THE PHYSICIAN STATES, "I AM NOT SURE WHY IT HAPPENED; MAYBE THE PT HAD AN INTRINSIC SPHINCTER DEFICIENCY" PRIOR TO THE SURGERY. PT/USER OUTCOME: PT IS INCONTINENT AND HAS NOT RECOVERED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357110 GREENLIGHT HPS LASER SYSTEM POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-0070

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability