BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 2801546 · Received October 18, 2012

    Report

    Report Number
    2937094-2012-01050
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    August 8, 2012
    Report Date
    September 25, 2012
    Manufacturer
    AMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE CODE REFERS TO FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER; A CODE REQUEST HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIDE-FIRING FIBER WAS NOTICED TO HAVE COMMENCED FORWARD FIRING DURING A PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. NO PT OR END USER 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 AMS 0010-2090 214H

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESSORIES| GREENLIGHT HPS LASER SYSTEM