BEUDAMED
    FDA Adverse Event Death Summary report: N

    GREENLIGHT SURGICAL LASER SYSTEM

    MDR report key: 2574053 · Received May 9, 2012

    Report

    Report Number
    2937094-2012-00394
    Event Type
    Death
    Date Received
    May 9, 2012
    Date of Event
    April 25, 2012
    Report Date
    April 25, 2012
    Manufacturer
    AMERICAN MED SYSTEMS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K092735
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN INDICATED THERE WAS NO DEVICE FAILURE, AND NO DEVICE EVAL IS ANTICIPATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE END OF A ROUTINE PVP PROCEDURE, THE PT EXPERIENCED A "MASSIVE MYOCARDIAL INFARCTION", AND THAT CPR AND LIFE SAVING MEASURES WERE PERFORMED FOR ONE HOUR AND THE PT COULD NOT BE RECEIVED. PER THE PHYSICIAN, THE PT'S DEATH WAS LIKELY DUE TO ANESTHESIA AND WAS UNRELATED TO THE LASER, WHICH FUNCTIONED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT SURGICAL LASER SYSTEM LASER SYSTEM GEX AMERICAN MED SYSTEMS, INC. 0010-0210

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death SURGICAL FIBER(S)