BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 2801552 · Received October 18, 2012

    Report

    Report Number
    2937094-2012-01080
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 20, 2012
    Manufacturer
    AMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    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 AT 27, 257 JOULES DURING A PROSTATE PROCEDURE. IT WAS ALSO REPORTED THAT THE FIBER CAP WAS OBSERVED TO BE DAMAGED. A SECOND FIBER WAS USED AND REPORTED UNDER (REFERENCE MFR REPORT NUMBER 2937094-2012-01081); THE CASE WAS COMPLETED WITH THE SECOND 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 212H

    Patients

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