BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS

    MDR report key: 1887174 · Received October 26, 2010

    Report

    Report Number
    2937094-2010-00877
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    May 29, 2008
    Report Date
    September 15, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CTR - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE REACHED BECAUSE THE COURT DOCUMENTS DID NOT IDENTIFY OR RETURN THE DEVICE. NO ATTEMPTS HAVE BEEN MADE DIRECTLY TO THE USER FACILITY SINCE THIS IS A LEGAL MATTER.

    Description of Event or Problem · 1

    EVENT IS DESCRIBED BY COURT DOCUMENTS VIA LEGAL CASE. DURING SURGICAL PROCEDURE - LASER ABLATION OF THE PROSTATE, THE PT EXPERIENCED COMPLETE COMPLEX OBLITERATION OF ANTERIOR URETHRA. NO OTHER INFO REGARDING THE PT CARE OR OUTCOME IS AVAILABLE TO AMERICAN MEDICAL SYSTEM AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT HPS LASER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CTR - SILICON VALLEY NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O