BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3223363 · Received July 10, 2013

    Report

    Report Number
    2937094-2013-00735
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    February 27, 2013
    Report Date
    April 17, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MFR REPORT #: 2937094-2013-00497. THE COMPONENT CODES 814 FIBER AND 424 CAP REFER TO THE RESULTS CODE 642 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. CHAR AND DETRITUS WERE ALSO OBSERVED ON THE CAP SURFACE. THE IDENTIFIED ISSUES MAY ACTIVATE THE LASER SYSTEMS FIBERLIFE FUNCTION WHICH WILL MODULATE THE POWER SHOWING A PULSING BEAM OR THE SYSTEM WILL REVERT TO STANDBY MODE. THE CIRCUMFERENTIAL FRACTURE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE FIBER TIP BURNED AT 33,736 JOULES OF USE; THE FIBER WAS REPLACED AND THE CASE CONTINUED WITH A SECOND FIBER . AT 28,739 JOULES OF USE WHILE USING THE SECOND FIBER, THE FIBER CARD TIMED OUT. THE PHYSICIAN REVERTED TO TURP TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OR INJURY. THIS REPORT IS FOR THE FIRST FIBER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316009 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 142A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other