BEUDAMED
    FDA Adverse Event Death Summary report: N

    GREENLIGHT SURGICAL LASER SYSTEM

    MDR report key: 2629625 · Received June 22, 2012

    Report

    Report Number
    2937094-2012-00656
    Event Type
    Death
    Date Received
    June 22, 2012
    Date of Event
    May 31, 2012
    Report Date
    June 1, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR LABELING STATES AS WITH CONVENTIONAL ENDOSCOPIC TREATMENT, ADVERSE REACTIONS. MAY OCCUR FOLLOWING LASER TREATMENT. IN EXTREME CASES, DEATH MAY OCCUR DUE TO PROCEDURAL COMPLICATION, CONCURRENT ILLNESS OR THE APPLICATION OF THE LASER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHORTLY AFTER THE COMPLETION OF A PVP PROCEDURE, THE PT EXPIRED "IN RECOVERY." IT WAS REPORTED BY THE MFR REP THAT THERE WERE NO ABNORMALITIES NOTED WITH THE LASER EQUIPMENT DURING THE CASE, HOWEVER, DURING PROSTATE VAPORIZATION, THE PT EXPERIENCED AN ARTERIAL BLEED THAT WAS DIFFICULT TO CONTROL. IT WAS REPORTED THAT THE PHYSICIAN WAS NOT ABLE TO CONTROL THE ARTERIAL BLEED WITH THE LASER COAGULATION FEATURE AND SEVERAL OTHER INSTRUMENTS BEFORE PUTTING IN A CATHETER AND HOLDING TRACTION (APPLYING PRESSURE). THE ANESTHESIOLOGIST ORDERED BLOOD FOR TRANSFUSION, HOWEVER THE MFR REP WAS NOT AWARE IF ADMINISTERED, BUT RECALLS THE PT'S NUMBERS BEING OKAY. THE CASE WAS COMPLETED; THE PT WAS REPORTED TO HAVE PASSED AWAY POST-OPERATIVELY WHILE IN RECOVERY. THE EXACT CAUSE OF DEATH IS UNK TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT SURGICAL LASER SYSTEM LASER SYSTEM GEX AMERICAN MEDICAL SYSTEMS, INC. 0010-0070

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R SURGICAL FIBER(S)