BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2891313 · Received December 21, 2012

    Report

    Report Number
    2937094-2012-01337
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 23, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE (B)(4) 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 DURING A PROSTATE PROCEDURE, THE SIDE-FIRING SURGICAL FIBER WAS OBSERVED TO FIRE "STRAIGHT." NO REPORT IS PATIENT OR END USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 220A

    Patients

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