BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3131205 · Received May 23, 2013

    Report

    Report Number
    2937094-2013-00610
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODES FIBER AND CAP REFER TO THE RESULTS CODE THERMAL PROBLEM. FIBER ANALYSIS: THE FIBER WAS FOUND TO HAVE A CIRCUMFERENTIAL FRACTURE OF THE GLASS CAP, DISTAL TO THE FIBER/CAP FUSION ZONE. THE FIBER PROXIMAL TO THE FRACTURE WAS FOUND TO ROTATE INDEPENDENTLY OF THE METAL CAP; DETRITUS AND CHAR WAS ALSO OBSERVED ON THE METAL CAP. THE IDENTIFIED ISSUES MAY ACTIVATE THE FIBERLIFE FUNCTION WHICH WOULD MODULATE THE POWER SHOWING A PULSING BEAM OR THE SYSTEM WOULD BE PLACED INTO STANDBY MODE. THIS ISSUE MAY ALSO RESULT IN A FORWARD-FIRING CONDITION OF THE SIDE-FIRING SURGICAL FIBER. THE MOST PROBABLE ROOT CAUSE OF THE DEVICE ISSUE WAS DETERMINED TO BE LOCALIZED HEAT ACCUMULATION/USER HANDLING, DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. REFERENCE MFR. REPORT NUMBER: 2937094-2013-00609, 2937094-2013-00611.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THREE FIBERS WERE USED AND ALL EXPERIENCED THE FIBER CAP NOT ROTATING WITH THE FIBER WHEN LASING RESULTING IN SIGNIFICANTLY DIMINISHED VAPORIZATION EFFICIENCY. THE FIRST FIBER AT 22338 JOULES; SECOND FIBER AT 69153 JOULES; THIRD FIBER AT 79790 JOULES. THE PROCEDURE WAS COMPLETED USING A FOURTH FIBER. "NO PATIENT INJURY" REPORTED. THIS REPORT IS FOR THE SECOND SURGICAL FIBER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229019 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 245B

    Patients

    Seq Age Sex Outcome Treatment
    1