BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 3312720 · Received August 15, 2013

    Report

    Report Number
    2937094-2013-00953
    Event Type
    Injury
    Date Received
    August 15, 2013
    Date of Event
    February 1, 2013
    Report Date
    July 30, 2013
    Manufacturer
    AMS
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE: "UNROOFED MIDLINE PROSTATE CYST MISLED INTO A STRICKTURE WITH OBLITERATIVE BLADDER NECK CONTRACTURE FOLLOWING A LASER PROSTATECTOMY": RICHILDA RED DIAZ, JOO YONG LEE, YOUNG DEUK CHOI, KANG SU CHO; 2013 KOREAN CONTINENCE SOCIETY.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A CASE REPORT, "UNROOFED MIDLINE PROSTATE CYST MISLED INTO A STRICTURE WITH OBLITERATIVE BLADDER NECK CONTRACTURE FOLLOWING A LASER PROSTATECTOMY (DIAZ, LEE, CHOI, CHO)": IT WAS REPORTED THAT FOLLOWING A POTASSIUM TITANYL PHOSPHASE LASER PHOTOSELECTIVE VAPORIZATION OF PROSTATE, THIS PT PRESENTED, AT 3 MONTHS POST PROCEDURE, WITH: PERSISTENT LOWER URINARY TRACT SYMPTOMS, OBLITERTIVE BLADDER NECK CONTRACTURE WITH AN INCIDENTAL, MISLEADING, AND RARE PRESENCE OF AN UNROOFED MIDLINE ANTERIOR PROSTATIC CYST PRESENTING AS A STRICTURE. A RESECTION OF THE BLADDER NECK CONTRACTURE WAS PERFORMED AS WELL AS TRANSURETHRAL RESECTION OF CYST WALL AND COMPLETION TURP. UNK IF A LASERSCOPE/AMS KTP LASER WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394617 GREENLIGHT HPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R