BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 2902971 · Received December 26, 2012

    Report

    Report Number
    2937094-2012-01284
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SIDE-FIRING FIBER WAS NOTICED TO HAVE COMMENCED FORWARD FIRING AT 6,614 JOULES DURING A PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE SURGICAL PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT HPS BPH FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 228H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ACCESSORIES| GREENLIGHT SURGICAL LASER SYSTEM